Journal articles on the topic 'Master of Clinical Research'
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Cronenwett, Linda R. "Clinical Research by Master??s Students." JONA: The Journal of Nursing Administration 17, no. 1 (January 1987): 6???7. http://dx.doi.org/10.1097/00005110-198701000-00002.
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Park, Jay J. H., Louis Dron, and Edward J. Mills. "Moving forward in clinical research with master protocols." Contemporary Clinical Trials 106 (July 2021): 106438. http://dx.doi.org/10.1016/j.cct.2021.106438.
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Mingels, S., and M. Granitzer. "Master thesis research ready-to-use for clinical application." Physiotherapy 102 (November 2016): e80-e81. http://dx.doi.org/10.1016/j.physio.2016.10.078.
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Cecchini, Michael, Eric H. Rubin, Gideon M. Blumenthal, Kassa Ayalew, Howard A. Burris, Michele Russell-Einhorn, Hildy Dillon, et al. "Challenges with Novel Clinical Trial Designs: Master Protocols." Clinical Cancer Research 25, no. 7 (January 29, 2019): 2049–57. http://dx.doi.org/10.1158/1078-0432.ccr-18-3544.
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Bøttcher Berthelsen, Connie, Marianne Vamosi, and Bente Martinsen. "Camouflaging nursing research-related tasks in clinical practice–Experiences of newly-graduated masters of science in nursing." Journal of Nursing Education and Practice 10, no. 3 (November 25, 2019): 42. http://dx.doi.org/10.5430/jnep.v10n3p42.
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Objective: To explore and describe how newly-graduated Masters of Science in Nursing experienced engaging in nursing research-related tasks in daily clinical practice.Methods: Fifteen nurses withholding a Masters of Science in Nursing degree were recruited from our longitudinal cohort study and interviewed six months after graduation in December 2016 (n = 10) and in December 2017 (n = 5), respectively. Data were analysed using Graneheim and Lundmann’s qualitative manifest and latent content analysis. Lincoln and Guba’s four criteria of trustworthiness were followed.Results: The main theme of the overall interpretation was Camouflaging nursing research-related tasks in clinical practice. The main theme describe the Master of Science in Nursing graduates as highly motivated to use their new academic skills in clinical practice and how they have to hide their engagement in research due to the barriers, which are outlined in the three themes: the position as time restrainer, the management as gatekeeper, and the nursing culture as norm setter.Conclusions: The study contributes with knowledge on how the Master of Science in Nursing graduates struggle to use their academic skills in clinical practice and how they felt the need to camouflage their commitment in research because it was not well reputed among their colleagues.
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Bitterman, Danielle S., Daniel N. Cagney, Lisa L. Singer, Paul L. Nguyen, Paul J. Catalano, and Raymond H. Mak. "Master Protocol Trial Design for Efficient and Rational Evaluation of Novel Therapeutic Oncology Devices." JNCI: Journal of the National Cancer Institute 112, no. 3 (August 27, 2019): 229–37. http://dx.doi.org/10.1093/jnci/djz167.
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Abstract Historically, the gold standard for evaluation of cancer therapeutics, including medical devices, has been the randomized clinical trial. Although high-quality clinical data are essential for safe and judicious use of therapeutic oncology devices, class II devices require only preclinical data for US Food and Drug Administration approval and are often not rigorously evaluated prior to widespread uptake. Herein, we review master protocol design in medical oncology and its application to therapeutic oncology devices, using examples from radiation oncology. Unique challenges of clinical testing of radiation oncology devices (RODs) include patient and treatment heterogeneity, lack of funding for trials by industry and health-care payers, and operator dependence. To address these challenges, we propose the use of master protocols to optimize regulatory, financial, administrative, quality assurance, and statistical efficiency of trials evaluating RODs. These device-specific master protocols can be extrapolated to other devices and encompass multiple substudies with the same design, statistical considerations, logistics, and infrastructure. As a practical example, we outline our phase I and II master protocol trial of stereotactic magnetic resonance imaging–guided adaptive radiotherapy, which to the best of our knowledge is the first master protocol trial to test a ROD. Development of more efficient clinical trials is needed to promote thorough evaluation of therapeutic oncology devices, including RODs, in a resource-limited environment, allowing more practical and rapid identification of the most valuable advances in our field.
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Ray, Dee, Kimberly Jayne, and Raissa Miller. "Master Counselors as Teachers: Clinical Practices of Counselor Educators." Journal of Mental Health Counseling 36, no. 1 (January 1, 2014): 78–94. http://dx.doi.org/10.17744/mehc.36.1.r71044x11x44tn5p.
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Using a mixed methods design, we surveyed 117 counselor educators to explore their clinical practices and their perceptions of the impact of clinical practice on teaching, supervision, research, and service. The results indicate that clinical practice had the greatest influence on their supervision and teaching. A negative relationship between years served as a counselor educator and hours engaged in counseling was found. Through qualitative analysis, we identified several themes related to counselor educators' decisions to engage in clinical practice, among them staying relevant, enhancing teaching and supervision, and staying current in the field. Implications for counselors and counselor educators are discussed.
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Nayak, Arun. "Clinical photography: A to Z." APOS Trends in Orthodontics 7 (February 1, 2017): 19–28. http://dx.doi.org/10.4103/2321-1407.199175.
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Clinical orthodontic photography is a vital skill set that every practicing orthodontist should master to be successful at the documentation of case records, patient education, peer presentations, marketing, and at acquiring additional certifications. This article aims to review various aspects of orthodontic photography and relevant research.
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Barr, Frances. "Masters in clinical veterinary research." Veterinary Record 179, no. 8 (August 20, 2016): i—ii. http://dx.doi.org/10.1136/vr.i4522.
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Berthelsen, Connie, Bente Martinsen, and Marianne Vamosi. "Master of Science in Nursing students’ expectations to participate in nursing research-related tasks in clinical practice after completing their education – A cross-sectional survey." Journal of Nursing Education and Practice 10, no. 5 (December 25, 2019): 1. http://dx.doi.org/10.5430/jnep.v10n5p1.
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Objective: To describe Master of Science in Nursing students’ expectations to participate in nursing research-related tasks in daily clinical practice after completing their education.Methods: To support this assumption a descriptive cross-sectional study was conducted to describe Master of Science in nursing students’ expectations to participate in nursing research-related tasks in daily clinical practice after completing their education. Data were collected using a 41-item structured questionnaire.Results: A convenience sample of Master of Science in Nursing students (n = 116) was recruited during their third semester and 92 (79.3%) students replied the questionnaire. The results showed how 91.3% of the students expressed high expectations regarding their possibilities for participation in nursing research-related tasks in clinical practice. However, 64.1% doubted that time and resources would be allocated to nursing research.Conclusions: The key motivator for the students was to improve patient care, further develop clinical practice, and strengthen the nursing profession. However, the literature suggests that colleagues and the nursing management in clinical practice impose certain barriers that prevent nurses from participating in research.
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Musgrave, Elaine. "The Master of Science in Clinical and Translational Research at the University of Connecticut." Clinical and Translational Science 1, no. 2 (September 2008): 92. http://dx.doi.org/10.1111/j.1752-8062.2008.00047.x.
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Guzzetta, Cathie E. "Critical Care Research: Weaving a Body-Mind-Spirit Tapestry." American Journal of Critical Care 13, no. 4 (July 1, 2004): 320–27. http://dx.doi.org/10.4037/ajcc2004.13.4.320.
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Master weavers historically characterize the weaving of a tapestry as a calling, a transformation, a healing or sacred work. Tapestries are created by the collective efforts of many and are configured by the weavers’ consciousness and spirit. A holistic framework used to weave a body-mind-spirit tapestry for guiding holistic clinical practice and research is described. Various research studies that document the effects of holistic interventions on patients’ outcomes are examined. Implications for clinical practice are explored.
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Cruz, Isabel Cristina Fonseca da. "The Professional Master in Nursing at the Fluminense Federal University Nursing School will begin in 2004." Online Brazilian Journal of Nursing 2, no. 3 (October 20, 2004): 84–85. http://dx.doi.org/10.17665/1676-4285.20034893.
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The role of nurse with Master Degree represents an challenge career opportunity for professional nurses. Currently, there are only 2 Professional Master in Nursing in Brazil, one is at São Paulo Federal University (SP) and the other, recently approved by CAPES, is at Fluminense Federal University (RJ). At the Fluminense Federal University, the Professional Master in Nursing Program was designed for experienced nurses who is seeking preparation for advanced practice as a clinical specialist, educator, researcher, or administrator. It includes course work and clinical experience in advanced health assessment, physiology, pathophysiology and pharmacology, as well as research, nursing theories, health promotion and disease prevention, healthcare policy, health and culture, diagnostic reasoning, and clinical decision making. In addition to course work, nurses are required to publish an original article and to produce a dissertation. The Professional Master in Nursing encompass a 2 year program of study with specialized clinical experiences. Upon graduation, the nurse will have a base of knowledge in a specific area of nursing care; and can participate knowledgeably in research activity and application. Advanced clinical education and experience based on scientifc evidences have been identified as requirements for practice as a nurse with Professional Master Degree. The nursing practice has recently expanded as a result of changes occurring in health care settings, including increased acuity of hospitalized patients, demands of management hability to reduce length of stay and to coordinate patient/family care. The scope of practice for nurses with a Professional Master Degree is broad-based and involves, mainly, providing advanced nursing care to patients and their families according to the practice setting and patient population. For example, it may comprehend also therapeutic procedure work, aspects of case management, discharge planning, monitoring quality standards, clinical research, undergraduate preceptorship, and inservice education of nursing staff for the instituition. The Professional Master in Nursing at the Fluminense Federal University will offer a unique advanced practice opportunity for nurses to develop their nursing careers and for healthcare institutions and nursing faculties to improve the quality of their services.The Professional Master in Nursing at the Fluminense Federal University will be offered in March 2004. Do not miss the deadlines!
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Lenárt, Sára, Peter Lenárt, Jan Šmarda, Ján Remšík, Karel Souček, and Petr Beneš. "Trop2: Jack of All Trades, Master of None." Cancers 12, no. 11 (November 11, 2020): 3328. http://dx.doi.org/10.3390/cancers12113328.
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Trophoblast cell surface antigen 2 (Trop2) is a widely expressed glycoprotein and an epithelial cell adhesion molecule (EpCAM) family member. Although initially identified as a transmembrane protein, other subcellular localizations and processed forms were described. Its congenital mutations cause a gelatinous drop-like corneal dystrophy, a disease characterized by loss of barrier function in corneal epithelial cells. Trop2 is considered a stem cell marker and its expression associates with regenerative capacity in various tissues. Trop2 overexpression was described in tumors of different origins; however, functional studies revealed both oncogenic and tumor suppressor roles. Nevertheless, therapeutic potential of Trop2 was recognized and clinical studies with drug–antibody conjugates have been initiated in various cancer types. One of these agents, sacituzumab govitecan, has been recently granted an accelerated approval for therapy of metastatic triple-negative breast cancer. In this article, we review the current knowledge about the yet controversial function of Trop2 in homeostasis and pathology.
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Dudina, Oksana. "PECULIARITIES OF TRAINING MASTERS IN MEDICINE IN CHINISE UNIVERSITIES." Academic Notes Series Pedagogical Science 1, no. 192 (March 2021): 63–66. http://dx.doi.org/10.36550/2415-7988-2021-1-192-63-66.
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The article investigates and theoretically summarizes the peculiarities of training doctors at the master's level at the universities of ROC. Higher education in China is characterized by numerous changes due to the accumulation and adaptation of advanced successful experience in training specialists in different countries of the world. In this context, the property of scientists and educators of ROC concerning the organization of professional training of masters in medicine is of particular interest for Ukraine. Scientists are constantly searching for solutions and improving higher medical education in ROC. In the universities of the Republic of China, according to the field of study, the degree of master in medicine can be obtained as a professional degree and scientific degree. As a result, after completing the master's program in professional field, the master may work in positions such as senior physician, senior physician in health care, senior dentist, senior pharmaceutical, and the master in research field may work as the doctor-scientist, who carries out medical research as the main professional activity. The name of medical degrees is also different, for the professional field – clinical medicine, for the research field – preclinical medicine. Clinical medicine includes such areas of master's programs in medicine as health care, dentistry, pharmacological science; preclinical medicine includes clinical medicine, preventive medicine, dentistry, the science of human progress, the history of science and technology, biomedical engineering, social medicine and health management. The article examines the experience of implementing master's programs in medicine at higher educational institutions in China. The competence-based approach, forms and specialization of training in the organization of training and practicing students due to master's programs in medicine in ROC were determined.
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Cruz, Isabel Cristina Fonseca da. "The professional master in nursing: an new opportunity for brazilian nurse and an improvement in quality for the healthcare instituition." Online Brazilian Journal of Nursing 2, no. 1 (April 2, 2003): 1–2. http://dx.doi.org/10.17665/1676-4285.20034796.
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The role of nurse with Master Degree represents an challenge career opportunity for professional nurses. Currently, there are only 2 Professional Master in Nursing in Brazil, one is at São Paulo Federal University (SP) and the other, recently created, is at Fluminense Federal University (RJ). At the Fluminense Federal University, the Professional Master in Nursing includes course work and clinical experience in advanced health assessment, physiology, pathophysiology and pharmacology, as well as research, nursing theories, health promotion and disease prevention, healthcare policy, health and culture, diagnostic reasoning, and clinical decision making. In addition to course work, nurses are required to publish an original article and to produce a dissertation. The Professional Master in Nursing encompass a 2 year program of study with specialized clinical experiences. Advanced clinical education and experience based on scientifc evidences have been identified as requirements for practice as a nurse with Professional Master Degree. The nursing practice has recently expanded as a result of changes occurring in health care settings, including increased acuity of hospitalized patients, demands of management hability to reduce length of stay and to coordinate patient/family care. The scope of practice for nurses with a Professional Master Degree is broad-based and involves, mainly, providing advanced nursing care to patients and their families according to the practice setting and patient population. For example, it may comprehend also therapeutic procedure work, aspects of case management, discharge planning, monitoring quality standards, clinical research, undergraduate preceptorship, and inservice education of nursing staff for the instituition. The Professional Master in Nursing at the Fluminense Federal University will offer a unique advanced practice opportunity for nurses to develop their nursing careers and for healthcare institutions and nursing faculties to improve the quality of their services.
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Robinson, Georgeanna F. W. B., Charity G. Moore, Kathleen M. McTigue, Doris M. Rubio, and Wishwa N. Kapoor. "Assessing Competencies in a Master of Science in Clinical Research Program: The Comprehensive Competency Review." Clinical and Translational Science 8, no. 6 (August 29, 2015): 770–75. http://dx.doi.org/10.1111/cts.12322.
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Navar, Ann Marie, Eric D. Peterson, Dylan L. Steen, Daniel M. Wojdyla, Robert J. Sanchez, Irfan Khan, Xue Song, Matthew E. Gold, and Michael J. Pencina. "Evaluation of Mortality Data From the Social Security Administration Death Master File for Clinical Research." JAMA Cardiology 4, no. 4 (April 1, 2019): 375. http://dx.doi.org/10.1001/jamacardio.2019.0198.
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Zhang, Dandan, Junhong Chen, Wei Li, Daniel Bautista Salinas, and Guang-Zhong Yang. "A microsurgical robot research platform for robot-assisted microsurgery research and training." International Journal of Computer Assisted Radiology and Surgery 15, no. 1 (October 11, 2019): 15–25. http://dx.doi.org/10.1007/s11548-019-02074-1.
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Abstract Purpose Ocular surgery, ear, nose and throat surgery and neurosurgery are typical types of microsurgery. A versatile training platform can assist microsurgical skills development and accelerate the uptake of robot-assisted microsurgery (RAMS). However, the currently available platforms are mainly designed for macro-scale minimally invasive surgery. There is a need to develop a dedicated microsurgical robot research platform for both research and clinical training. Methods A microsurgical robot research platform (MRRP) is introduced in this paper. The hardware system includes a slave robot with bimanual manipulators, two master controllers and a vision system. It is flexible to support multiple microsurgical tools. The software architecture is developed based on the robot operating system, which is extensible at high-level control. The selection of master–slave mapping strategy was explored, while comparisons were made between different interfaces. Results Experimental verification was conducted based on two microsurgical tasks for training evaluation, i.e. trajectory following and targeting. User study results indicated that the proposed hybrid interface is more effective than the traditional approach in terms of frequency of clutching, task completion time and ease of control. Conclusion Results indicated that the MRRP can be utilized for microsurgical skills training, since motion kinematic data and vision data can provide objective means of verification and scoring. The proposed system can further be used for verifying high-level control algorithms and task automation for RAMS research.
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Fontana, Elena, Mauro Adenzato, Jacopo S. Penso, Ivan Enrici, and Rita B. Ardito. "On the Relationship between Theory of Mind and Syntax in Clinical and Non-Clinical Populations: State of the Art and Implications for Research." Open Psychology Journal 11, no. 1 (June 21, 2018): 95–104. http://dx.doi.org/10.2174/1874350101811010095.
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Background:Over the years, different explanations have been given on the relationship between syntax and Theory of Mind,i.e., the ability to attribute mental states to others and predict, describe, and explain behavior based on such mental states. In the present study, we focus on the relationship between false-belief understanding as a crucial aspect of Theory of Mind, and on the ability to master the syntax of complementation,i.e., the ability to produce and comprehend sentences in a recursive way.Objective:Our purpose is to test two main hypotheses on the relationship between false-belief understanding and the ability to master the syntax of complementation: the dependence and the independence of false-belief understanding on syntactic complementation.Method:We analyze studies on children with typical development, deaf children with deaf signing or hearing parents, children with specific language impairment, children diagnosed with autism spectrum disorder, longitudinal and training studies, and studies on adults with neuropsychological disorders.Conclusion:Strengths and weaknesses of the two hypotheses are discussed and limitations of the current state of knowledge are presented. A lifespan approach taking into account both the emergence and maintenance of false-belief understanding and using both implicit and explicit false-belief tasks is proposed to face the issue discussed.
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Jennings, Len, Ashley Sovereign, Nancy Bottorff, Melissa Pederson Mussell, and Christopher Vye. "Nine Ethical Values of Master Therapists." Journal of Mental Health Counseling 27, no. 1 (January 1, 2005): 32–47. http://dx.doi.org/10.17744/mehc.27.1.lmm8vmdujgev2qhp.
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This study employed the Consensual Qualitative Research method (Hill, Thompson, & Williams, 1997) to reanalyze interview data from a previous qualitative study of the personal characteristics of master therapists (Jennings & Skovholt, 1999). Previous research has demonstrated that therapists utilize a variety of resources when making ethical decisions, including professional codes of conduct and their own values. The current study's analysis of 10 master therapists' interviews resulted in the identification of nine ethical values related to their clinical practice: (a) relational connection, (b) autonomy, (c) beneficence, (d) nonmaleficence, (e) competence, (f) humility, (g) professional growth, (h) openness to complexity and ambiguity, and (i) self-awareness. Conducting oneself ethically is a critical task of the competent therapist (American Psychological Association, 2002). Making the best ethical decisions can be extremely challenging for most therapists due to the multitude of complex ethical situations that arise in practice. The goal of this study is to examine the ethical values of therapists considered to be "the best of the best" by their professional colleagues. It is hoped that such an examination will help to illuminate the ethical values that these master therapists seem to draw upon in their work.
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Coles, Christian, and Martin G. Ottolini. "Infectious Disease Clinical Research Program: Building the Bench." Military Medicine 184, Supplement_2 (November 1, 2019): 66–70. http://dx.doi.org/10.1093/milmed/usz094.
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ABSTRACT The role of physicians in the U.S. Armed Forces is diverse, encompassing a wide array of skills and responsibilities to provide superior healthcare to their patients and to advance military medicine. In addition to healthcare delivery and medical education, military physicians are engaged in public health, operational medicine, and cutting-edge medical research. Thus, clinical research is a crucial component of Graduate Medical Education (GME) and supports critical thinking (knowledge, skills, and abilities) and the development of leadership skills among U.S. military physicians. The Infectious Disease Clinical Research Program (IDCRP) education mission was established in 2005 with the overall goal of supporting the development and training of the next generation of clinical researchers in infectious diseases and related public health disciplines in the Armed Forces using several strategies, including didactic learning, mentored research, and research engagement. Through involvement in the IDCRP, infectious disease fellows, residents (e.g., surgical, internal medicine, and pediatrics), and Master of Public Health (MPH) students have continued their education and gained valuable skills related to clinical research. Trainees either conduct research with IDCRP mentors or participate in IDCRP-led practicum experiences, with research projects ranging from epidemiologic studies to microbiological assessments. Consistent with the needs of the Military Health System (MHS), and in accordance with Accreditation Council for Graduate Medical Education goals, the IDCRP provides opportunities for medical and graduate students, residents, and infectious disease fellows to conduct mentored research within the MHS, as well as gain important leadership skills in the conduct of clinical research. Overall, IDCRP continues to further infectious disease research through the support and education of the next generation of active-duty infectious disease researchers in the MHS.
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Di Liello, Raimondo, Maria Carmela Piccirillo, Laura Arenare, Piera Gargiulo, Clorinda Schettino, Adriano Gravina, and Francesco Perrone. "Master Protocols for Precision Medicine in Oncology: Overcoming Methodology of Randomized Clinical Trials." Life 11, no. 11 (November 17, 2021): 1253. http://dx.doi.org/10.3390/life11111253.
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Randomized clinical trials are considered the milestones of clinical research in oncology, and guided the development and approval of new compounds so far. In the last few years, however, molecular and genomic profiling led to a change of paradigm in therapeutic algorithms of many cancer types, with the spread of different biomarker-driven therapies (or targeted therapies). This scenario of “personalized medicine” revolutionized therapeutic strategies and the methodology of the supporting clinical research. New clinical trial designs are emerging to answer to the unmet clinical needs related to the development of these targeted therapies, overcoming the “classical” structure of randomized studies. Innovative trial designs able to evaluate more than one treatment in the same group of patients or many groups of patients with the same treatment (or both) are emerging as a possible future standard in clinical trial methodology. These are identified as “master protocols”, and include umbrella, basket and platform trials. In this review, we described the main characteristics of these new trial designs, focusing on the opportunities and limitations of their use in the era of personalized medicine.
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Mazzarella, Luca, Stefania Morganti, Antonio Marra, Dario Trapani, Giulia Tini, Piergiuseppe Pelicci, and Giuseppe Curigliano. "Master protocols in immuno-oncology: do novel drugs deserve novel designs?" Journal for ImmunoTherapy of Cancer 8, no. 1 (March 2020): e000475. http://dx.doi.org/10.1136/jitc-2019-000475.
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The rapid rise to fame of immuno-oncology (IO) drugs has generated unprecedented interest in the industry, patients and doctors, and has had a major impact in the treatment of most cancers. An interesting aspect in the clinical development of many IO agents is the increasing reliance on nonconventional trial design, including the so-called ‘master protocols’ that incorporate various adaptive features and often heavily rely on biomarkers to select patient populations most likely to benefit. These novel designs promise to maximize the clinical benefit that can be reaped from clinical research, but are not without costs. Their acceptance as solid evidence basis for use outside of the research context requires profound cultural changes by multiple stakeholders, including regulatory bodies, decision-makers, statisticians, researchers, doctors and, most importantly, patients. Here we review characteristics of recent and ongoing trials testing IO drugs with unconventional design, and we highlight trends and critical aspects.
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Umam, Aguswan Khotibul. "Sinergitas Tiga Pilar Penjamin Mutu Pendidikan dalam Implementasi Kurikulum 2013 Melalui Proses Superfisi Akademik pada Madrasah Aliyah Sekota Metro." Tapis : Jurnal Penelitian Ilmiah 1, no. 02 (December 4, 2017): 232. http://dx.doi.org/10.32332/tapis.v1i02.873.
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This research is intended to describe critically and qualitatively the synergy among Islamic education supervisor, head master, and Islamic education teacher in implementing 2013 curriculum through academic supervision. The data collecting techniques used in this research are observation, interview, and document review. The results of the research are (1) the supervision is conducted by Islamic education supervisor not only gradually but also incidentally through academic, administrative, and clinical supervision; (2) the academic supervision of Islamic education at MA Metro city is conducted based on qualified Islamic education supervisor, eight education quality standards, prime duty and function of Islamic education supervisor, effective madrasah management by head master, vision, mission and Islamic education strategy, and terms of reference of Islamic education supervision; 3) there are several problems that supervisor, head master, and Islamic education teacher have in implementing 2013 curriculum; 4) the synergy of quality assurance in implementing K13 must be based on maximum effort of Islamic education supervisor, head master, and Islamic education teachers at MA that are conducted according to eight terms of reference: inspecting, advising, monitoring, reporting, coordinating, and performing leadership.
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Auclair, Daniel, Kenneth Carl Anderson, David Avigan, Giada Bianchi, Noa Biran, Maria Chaudhry, Hearn J. Cho, et al. "The myeloma-developing regimens using genomics (MyDRUG) master protocol." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): TPS8057. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.tps8057.
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TPS8057 Background: Multiple myeloma (MM) is the second most prevalent blood cancer, representing approximately 1% of all cancers. Although overall survival has improved in recent years due to new approved agents, the vast majority of MM patients (pts) ultimately stop responding to treatment. Moreover, about a quarter of MM pts characterized as “high risk” experience limited benefit from existing treatments. Seminal genomic sequencing research efforts, such as the MMRF CoMMpass study, have highlighted that a large number of MM cases harbor potentially actionable oncogenic molecular alterations and published reports on small numbers of cases suggest that Precision Medicine (PM) interventions clinically targeting such actionable drivers may benefit MM pts. These results suggest that PM approaches in MM are possible and should be further studied clinically. To that end, we have launched MyDRUG, a master protocol aimed at developing new myeloma regimens based on individual pt’s genomics. Methods: This study is a Phase I-II, multicenter master protocol in functional high risk MM patients (i.e patients having progressed from baseline treatment within 18 months without maintenance or 3 years on maintenance) with 1-3 prior lines of therapy. Patients are screened for actionable genomic alterations on the CLIA-grade MI-ONCOSEQ platform. Patients with actionable alterations are assigned to the appropriate targeted agent used in combination with a backbone regimen ixazomib, pomalidomide and dexamethasone (IPd), whereas patients without such alterations go on an immune arm (see Table). Inclusion criteria include measurable disease (as measured by M-protein and FLC) and acceptable hematologic and metabolic functions. A maximum of 12 evaluable pts will be accrued onto the phase I portion of each arm and an additional 21 evaluable phase II pts will be accrued onto each arm for a total of 27 evaluable pts at the MTD combination dose. The primary objective of the study is to evaluate ORR per IMWG consensus criteria. Secondary objectives are to assess adverse events (AEs), progression-free survival, and overall survival (OS). Experimental correlative aims include assessing molecular or clonal response, molecular and immune signatures of resistance/response, MRD. Clinical trial information: NCT03732703. [Table: see text]
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Dickson, Dane J., Jennifer Maria Johnson, Raymond C. Bergan, Rebecca Owens, Vivek Subbiah, and Razelle Kurzrock. "The master observational trial–a novel method to unify precision oncology data collection." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): e19313-e19313. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e19313.
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e19313 Background: The Master Observational Trial (MOT) was recently created as a new master protocol that hybridizes the power of master interventional trials with the richness of real-world data (Cell, 2020). The MOT can be described as a series of prospective observational studies that are tied together through a common protocol, infrastructure, and organization. The MOT has broad application in many disease states but is particularly powerful in oncology. We herein expand our prior work to describe key details regarding how the MOT concept can fill multiple unmet needs in oncology. Methods: Through published information, white papers, and expert opinions we identified key unmet needs of oncology stakeholders. We reviewed the publicly available information of structure, organization, and data availability of the five largest genomic-outcome real-world data efforts. Common concerns included variability and reliability of biomarkers, the scientific rigor in real-world data, data silos, patient consent, and duplicated or disparate activities. We then determined how a specific application of the MOT in oncology could answer stakeholder concerns, integrate with current efforts, and also how to provide a model that would be equally valuable to academic and community clinics. Results: We identified significant scientific challenges with many of the current oncology real-world datasets in answering key concerns of stakeholders. We developed the Master Registry of Oncology Outcomes Associated with Testing and Treatment (ROOT) as the first national implementation of an oncology-centric MOT. We modeled how ROOT could fill scientific gaps in current data efforts and integrate with interventional and real-world efforts and help answer key concerns of stakeholders. We also identified solutions that would allow community and academic groups to participate in the same effort. Conclusions: An oncology-centric MOT has the potential to improve the quality of RWD in oncology and advance precision oncology in ways that are not fully addressed by current retrospective efforts. Reference Dickson DJ, Johnson J, Owens R, Bergan R, Subbiah V, Kurzrock R. (2020). The Master Observational Trial: A New Class of Master Protocol to Advance Precision Medicine. Cell 180, 9-14. Clinical trial information: NCT04028479 .
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Renfro, L. A., and D. J. Sargent. "Statistical controversies in clinical research: basket trials, umbrella trials, and other master protocols: a review and examples." Annals of Oncology 28, no. 1 (January 2017): 34–43. http://dx.doi.org/10.1093/annonc/mdw413.
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Rosenberg, Len, Hugh Levaux, Ross L. Levine, Amit Shah, James Denmark, Nyla Hereema, Melanie Owen, et al. "Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial." Therapeutic Innovation & Regulatory Science 55, no. 5 (May 16, 2021): 926–35. http://dx.doi.org/10.1007/s43441-021-00277-w.
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AbstractAdvances in genomic technologies and an increased understanding of the molecular pathogenesis of cancer have resulted in development of new effective, mutation-targeted therapies. In turn, these informed the development of Master Trial designs to test these therapies. The Beat Acute Myeloid Leukemia (BAML) Master Trial (Sponsor: The Leukemia & Lymphoma Society) tests several targeted therapies in patients aged ≥ 60 years with AML based on genomic profiling obtained within 7 days of study enrollment. We hypothesized that integrating operational strategies with new electronic technologies (e-technologies) might streamline the conduct and management of this Master Trial. BAML’s 5 core operational strategies revolve around the guiding principle of “patients first.” The e-technology platforms employed in BAML include: Clinical Oversight Platform: a central collaborative tool; e-Protocol/e-Source Upload/Electronic Data Capture Platform: digitizes the protocol, allows remote data monitoring, and collects/exports data in Study Data Tabulation Model format; and Data Review Platform: ingests data from different sources for clinical response and safety data reviews. The operational approaches, e-technologies and sponsor/contract research organization’s (CRO) expertise together allow: the complexity and size of the BAML Master Trial to be better managed; near real-time study data oversight; better collaboration, communication and training; improved data collection, enhanced transmission and accessibility; data integration, review and generation of reports; while maintaining data privacy, and compliance. Initial e-technology challenges were overcome through training, learning, discipline and adjustment. In conclusion, to successfully manage Master Trials, significant time should be spent re-evaluating, improving and developing new operational approaches.Clinical Trial Registration: Clinical Trials.gov Identifier: NCT03013998. https://clinicaltrials.gov/ct2/show/NCT03013998.
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Tran, David, Son Le, Bo Ma, Darin Falk, and Serge Zolotukhin. "EXTH-51. DEVELOPMENT OF A NOVEL GENE THERAPY APPROACH TARGETING GLIOBLASTOMA FOLLOWING ARTIFICIAL INTELLIGENCE (AI)-DIRECTED IDENTIFICATION OF THE GBM STATE." Neuro-Oncology 23, Supplement_6 (November 2, 2021): vi174—vi175. http://dx.doi.org/10.1093/neuonc/noab196.690.
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Abstract BACKGROUND Profound heterogeneity has severely hampered therapeutic advancements in GBM. Remarkably, however, GBM exhibits broad clinical and histopathologic overlaps suggesting the presence of a common state. The GBM state embodies network restructuring forced by founding mutations and perpetuated in subclones of GBM stem-like cells (GSCs). Successful targeting of the GBM state promises to circumvent the heterogeneity. METHODS To decipher the GBM state, we applied NETZEN, an AI suite integrating a deep neural network with gene network-based ranking, to first generate the reference GBM gene network from TCGA’s entire GBM RNAseq collection, and then identify the altered master regulatory gene subnetwork in GBM using a dataset containing >30 diverse patient-derived GSC lines and their paired differentiated cells, 6 astrocyte and 3 neuronal precursor cell lines. To develop a gene therapy against the GBM state, we screened a rAAV capsid library through GBM patient-derived xenografts (PDX) to identify variants with specific tropism for GBM cells that can deliver targeting constructs intratumorally. RESULTS We discovered a putative GBM state anchored by developmentally restricted master regulators. To validate its critical role, we deconstructed it using shRNA in a panel of PDX and uniformly observed improved tumor control and survival compared to controls (p< 0.05 in all lines). More notably, when the core GBM state was forcibly reconstructed in astrocytes, transformation into GSC-like cells occurred, as measured by single-cell analysis, neurosphere formation, and most importantly, development of lethal infiltrating brain tumors in 15/15 mice. Finally, selected novel rAAV capsids with 10-40-fold higher specificity for GBM cells were utilized in a shRNA-based rAAV platform to target key master regulators of the validated GBM state. CONCLUSIONS The GBM state is established by a developmental master regulator subnetwork permitting the creation of a first-of-its-kind, heterogeneity-agnostic GBM therapy. This AI-directed R&D program can be expanded to target other tumors.
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Valle, Juan W., T. R. Jeffry Evans, Colin J. McKay, Judith Dixon-Hughes, James Paul, Jamie Stobo, Susie Cooke, et al. "Precision-Panc Master Protocol: Personalizing treatment for pancreatic cancer ISRCTN14879538—Part of Precision-Panc United Kingdom." Journal of Clinical Oncology 37, no. 4_suppl (February 1, 2019): TPS460. http://dx.doi.org/10.1200/jco.2019.37.4_suppl.tps460.
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TPS460 Background: A major challenge of lower incidence cancer types is that to make significant advances a network approach is required to coordinate research, generate greater clinical capacity and recruit sufficient patients. This is particularly the case for pancreatic cancer (PC). To address this, we established Precision-Panc, a synergistic and dynamic platform aligning “discovery”, “preclinical” and “clinical” therapeutic development. Methods: Central to the clinical development is the Precision-Panc Master Protocol, a multi-centre “portal” protocol recruiting patients with known or suspected PC, to enable enrolment into PRIMUS (Pancreatic canceR Individualised Multi-arm Umbrella Study), examining different treatment regimens and/or biomarker development. Eligible patients are identified prior to the diagnostic biopsy to obtain Stage 1 (Screening) Consent for extra tissue to be taken in the same biopsy setting. Patients who already have a diagnosis are asked to provide additional research biopsy. Once the PC diagnosis is made, Stage 2 (Registration) Consent is obtained for molecular profiling at the central reference laboratory using Precision-Panc NGS Diagnostic (bespoke clinical grade assay), including germline testing of 12 PC predisposition genes. The results may inform eligibility for a PRIMUS study. There is no sample size calculation due to the nature of the Master Protocol; however, individual PRIMUS studies will be appropriately powered according to their study design and primary endpoint. Results: Adults (aged >16 years) with either a hypodense pancreatic mass highly suspicious of PC (+/- distant metastases) or histologically/cytologically confirmed PC and its variants; willing and able to undergo tumour biopsy to obtain sufficient tissue for molecular profiling; deemed suitable to receive chemotherapy and/or radiotherapy and/or surgery pending stage of disease; must give both Stage 1 and 2 informed consent. Conclusions: The study opened on 28 Dec 2017; by 25 Sep 2018, 67 patients have been screened for Precision-Panc, 43 of whom have gone on to be registered and 19 have then been randomised to the PRIMUS-001 study (first-line metastatic). Clinical trial information: ISRCTN14879538.
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Kaizer, Alexander M., Joseph S. Koopmeiners, Michael J. Kane, Satrajit Roychoudhury, David S. Hong, and Brian P. Hobbs. "Basket Designs: Statistical Considerations for Oncology Trials." JCO Precision Oncology, no. 3 (December 2019): 1–9. http://dx.doi.org/10.1200/po.19.00194.
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Progress in the areas of genomics, disease pathways, and drug discovery has advanced into clinical and translational cancer research. The latest innovations in clinical trials have followed with master protocols, which are defined by inclusive eligibility criteria and devised to interrogate multiple therapies for a given tumor histology and/or multiple histologies for a given therapy under one protocol. The use of master protocols for oncology has become more common with the desire to improve the efficiency of clinical research and accelerate overall drug development. Basket trials have been devised to ascertain the extent to which a treatment strategy offers benefit to various patient subpopulations defined by a common molecular target. Conventionally conducted within the phase II setting, basket designs have become popular as drug developers seek to effectively evaluate and identify preliminary efficacy signals among clinical indications identified as promising in preclinical study. This article reviews basket trial designs in oncology settings and discusses several issues that arise with their design and analysis.
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Pavisic, Jovana, Chankrit Sethi, Chris Jones, Stergios Zacharoulis, and Andrea Califano. "DIPG-40. TARGETING MASTER REGULATOR DEPENDENCIES IN DIFFUSE INTRINSIC PONTINE GLIOMA (DIPG)." Neuro-Oncology 22, Supplement_3 (December 1, 2020): iii294—iii295. http://dx.doi.org/10.1093/neuonc/noaa222.087.
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Abstract Diffuse intrinsic pontine glioma (DIPG) remains a fatal disease with no effective drugs to date. Mutation-based precision oncology approaches are limited by lack of targetable mutations and genetic heterogeneity. We leveraged systems biology methodologies to discover common targetable disease drivers—master regulator proteins (MRs)—in DIPG to expand treatment options. Using the metaVIPER algorithm, we interrogated an integrated low grade glioma and GBM gene regulatory network with 31 DIPG-gene expression signatures to identify tumor-specific MRs by differential expression of their transcriptional targets. Unsupervised clustering identified MR signatures of upregulated activity in RRM2/TOP2A in 13 patients, CD3D in 5 patients, and MMP7, TACSTD2, RAC2 and SLC15A1/SLC34A2 in individual patients, all of which can be targeted. Notably, intratumoral administration of etoposide by convection enhanced delivery was effective in murine proneural gliomas in which TOP2 was identified as a MR while RRM2—targetable by drugs such as cladribine—has been shown to be a positive regulator of glioma progression whose knock-down inhibits tumor growth. We also prioritized drugs by their ability to reverse MR-activity signatures using a large drug-perturbation database. Patients clustered by predicted drug sensitivities with distinct groups of tumors predicted to respond to proteasome inhibitors, Thiotepa or Volasertib all of which have early evidence in treating gliomas. We will refine this analysis in a multi-institutional study of >100 patient gene expression profiles to define MR signatures driving known biological/molecular disease subtypes, use DIPG cell lines recapitulating common MR architectures to optimize therapy prioritization, and validate our findings in vivo.
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Okuma, Hitomi Sumiyoshi, Kan Yonemori, Takuji Seo, Emi Noguchi, Keiko Wakakuwa, Ken Kato, Hitoshi Ichikawa, et al. "Circulating tumor DNA molecular profiling in rare cancer patients from the MASTER KEY Project." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): e14532-e14532. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e14532.
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e14532 Background: In April 2017, MASTER KEY Project, composed of a prospective registry study part and a multiple clinical trials part, was established to promote treatment development for rare cancers, which is lacking standard or investigational therapeutic options. Circulating tumor DNA (ctDNA) analysis by next-generation sequencing (NGS) has provided new insight into personalized medicine in a more accessible, non-invasive manner; however, most reports are focused on common cancers. We report genetic alterations detected by ctDNA NGS analysis in rare solid cancers. Methods: Prospectively consented patients (pts), also enrolled in MASTER KEY registry study, had ctDNA NGS testing at a CLIA-certified lab (Guardant360) for point mutations, indels, copy number amplifications, fusions, and microsatellite instability. Alterations were assessed for incidence according to cancer type, functional impact, therapeutic implications, and comparison with tissue NGS. Main inclusion criteria: 1) age ≥16, 2) histological diagnosis of rare cancer (annual incidence less than 6 cases per 100,000 population), cancer of unknown primary (CUP), or rare tissue subtypes of common cancers, 3) active metastatic / unresectable cancer, 4) a written consent. Results: From Nov. 2018 to Jan 2019, 50 pts had Guardant360 testing. Diseases included: soft tissue sarcoma (28), ovarian carc. (7), CUP (4), salivary gland tumor (3), thyroid carc. (2), GIST (1), adrenal cortical carc. (1), rare subtype of GI tract (1), malignant mesothelioma (1), nephroblastoma (1), NET (1), NUT carc. (1). All Japanese, male/female = 14/36, median age 61, ECOG performance status 0/1/2/3 = 30/19/0/1. 76% of pts (38/50) had ≥1 alteration detected, with median number of 2 alterations (range: 0-9), with VAF(0.1-60.3%); 87%(33/38) of those pts had a variant most likely pathogenic; 61% (20/33) of those pts had a variant potential for clinical action. Mean TAT was 10.3 days. 19 pts had tissue NGS testing and in 3 pts, alterations were detected by ctDNA NGS but not by tissue NGS. Updated results of 100 patients will be presented at the conference. Conclusions: Most rare cancer patients with advanced disease had a detectable genomic alteration by Guardant360. Clinical trial information: UMIN000034394.
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Burd, Amy, Richard L. Schilsky, John C. Byrd, Ross L. Levine, Vassiliki A. Papadimitrakopoulou, Roy S. Herbst, Mary W. Redman, Brian J. Druker, and David R. Gandara. "Challenges and approaches to implementing master/basket trials in oncology." Blood Advances 3, no. 14 (July 23, 2019): 2237–43. http://dx.doi.org/10.1182/bloodadvances.2019031229.
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Abstract The appetite for cutting-edge cancer research, across medical institutions, scientific researchers, and health care providers, is increasing based on the promise of true breakthroughs and cures with new therapeutics available for investigation. At the same time, the barriers for advancing clinical research are impacting how quickly drug development efforts are conducted. For example, we know now that under a microscope, patients with the same type of cancer and histology might look the same; however, the reality is that most cancers are driven by genomic, transcriptional, and epigenetic changes that make each patient unique. Additionally, the immunologic reaction to different tumor types is distinct among patients. The challenge for researchers developing new therapies today is vastly different than it was in the era of cytotoxics. Today, we must identify a sufficient number of patients harboring a rare mutation or other characteristic and match this to the right therapeutic option. This summary provides a guide to help inform the scientific cancer community about the benefits and challenges of conducting umbrella or basket trials (master trials), and to create a roadmap to help make this new and evolving form of clinical trial design as effective as possible.
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Ager, Casey R., Aleksandar Obradovic, Mikko Turunen, Mohsen Khosravi-Maharlooei, Charles Karan, Andrea Califano, and Charles G. Drake. "Abstract 3612: Elucidating and targeting master regulators of tumor infiltrating regulatory T cells." Cancer Research 82, no. 12_Supplement (June 15, 2022): 3612. http://dx.doi.org/10.1158/1538-7445.am2022-3612.
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Abstract Regulatory T cells (Tregs) are highly attractive targets for immunotherapy development, however, there remains a critical need for clinically actionable targeting strategies that specifically inhibit human tumor-infiltrating Tregs (TI-Tregs) while preserving function of cytotoxic effectors and peripheral non-tumor Tregs (P-Tregs). To this end, we sought to identify, validate, and target novel master regulators of TI-Tregs by leveraging a suite of next-generation bioinformatic tools and rigorous ex vivo and in vivo screening and validation methodologies. Specifically, we performed VIPER (Virtual Inference of Protein Activity) analysis on a large dataset of T cell transcriptional profiles from matched peripheral blood and tumors of 36 human patients, yielding 17 master regulator (MR) proteins predicted to uniquely drive the TI-Treg phenotype across cancers. To identify putative therapeutics that modulate TI-Treg MRs, we performed a systematic ex vivo drug screen with an unbiased panel of 1,554 FDA-approved and experimental compounds coupled to RNA sequencing (PLATE-Seq) on human TI-Tregs and P-Tregs. Drug candidates with preferential cytotoxic activity on TI-Tregs versus P-Tregs that also reversed MR transcriptional activity were thoroughly validated in vivo in the MC38 tumor model. In parallel, we performed a pooled in vivo CRISPR/Cas9 screen via the CHIME (CHimeric IMmune Editing) system to identify candidate MRs that regulate TI-Treg recruitment to and/or retention within MC38 tumors. By these approaches, we successfully validated an as-yet poorly described TI-Treg MR, TRPS1 (Transcriptional Repressor GATA Binding 1), which after genetic deletion across the hematopoietic compartment diminished TI-Tregs while preserving P-Tregs in MC38-bearing mice, and led to enhanced spontaneous control of MCA205 sarcomas. In addition, we found the widely used nucleoside analog chemotherapeutic Gemcitabine exhibits preferential inhibitory activity against human TI-Tregs versus P-Tregs, and validated in mice that at sub-clinical dose levels Gemcitabine exhibits immune-dependent therapeutic activity that significantly potentiates checkpoint blockade control of late-stage MC38 tumors. By single cell RNA sequencing of TI- and P-Tregs flow-sorted from Gemcitabine-treated mice, we observe specific depletion of a TI-Treg subset enriched for expression of TI-Treg MRs, including TRPS1. Together, these studies reveal new putative regulators of human TI-Tregs and identify a readily available clinical therapeutic that exhibits inhibitory activity against them. These findings specifically warrant future investigation into the role of TRPS1 in TI-Treg activity and clinical evaluation of low-dose Gemcitabine as a Treg-targeting strategy capable of enhancing checkpoint blockade immunotherapy. Citation Format: Casey R. Ager, Aleksandar Obradovic, Mikko Turunen, Mohsen Khosravi-Maharlooei, Charles Karan, Andrea Califano, Charles G. Drake. Elucidating and targeting master regulators of tumor infiltrating regulatory T cells [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 3612.
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Hepburn, A. C., R. E. Steele, R. Veeratterapillay, L. Wilson, E. E. Kounatidou, A. Barnard, P. Berry, et al. "The induction of core pluripotency master regulators in cancers defines poor clinical outcomes and treatment resistance." Oncogene 38, no. 22 (February 11, 2019): 4412–24. http://dx.doi.org/10.1038/s41388-019-0712-y.
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Barr, Frances. "Launch of BSAVA Masters in Clinical Veterinary Research." BSAVA Companion 2016, no. 9 (September 1, 2016): 20–21. http://dx.doi.org/10.22233/20412495.0916.20.
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Erickson, James C. "Master Class For Practitioners The art of practice informed by theory and the findings of research the use of Hypnosis in Anesthesia: A Master Class Commentary." International Journal of Clinical and Experimental Hypnosis 42, no. 1 (January 1994): 8–12. http://dx.doi.org/10.1080/00207149408409337.
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Vaidya, Riha, Joseph M. Unger, Lu Qian, Katherine Minichiello, Roy S. Herbst, David R. Gandara, Joel W. Neal, et al. "Representativeness of patients enrolled in the Lung Cancer Master Protocol (Lung-MAP)." Journal of Clinical Oncology 40, no. 16_suppl (June 1, 2022): 6543. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.6543.
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6543 Background: A major goal of Lung-MAP, a biomarker-driven master protocol conducted within the National Clinical Trials Network of the NCI using a public-private partnership, was to improve access to novel therapeutics. Representative enrollment of patient sub-groups in clinical trials is essential for improving confidence that trial findings are valid and applicable to all patients. We examined the representativeness of patients enrolled in Lung-MAP by demographic and area-level measures compared to patients in other advanced non-small cell lung cancer (NSCLC) trials and with the US NSCLC population. Methods: We analyzed data on patients enrolled to Lung-MAP between 2014-2020 according to sex, age ( < 65 years v. ≥ 65 years), race (White v. Black v. Asian), ethnicity (Hispanic v. not Hispanic), residence (rural v. urban), insurance type (Medicaid or no insurance v. private), and neighborhood socioeconomic deprivation (quintiles of Area Deprivation Index score). Rates were compared to SWOG-led NSCLC trials conducted between 2001-2020 (date range to provide sufficient power) and, where possible, to US NSCLC population rates using Surveillance, Epidemiology, and End Results (SEER) registry data (2014-2018). Two-sided tests of proportions at the 5% level were used for all comparisons. Results: 3,556 patients enrolled to Lung-MAP were compared to 2,267 patients enrolled to SWOG-led NSCLC studies. Lung-MAP patients were more likely to be ≥ 65 years old (57.2% v. 46.7%; p <.001) and from rural areas (17.3% v. 14.3%; p =.002) but less likely to be female (38.6% v. 47.2%; p <.001), Asian (2.7% v. 5.1%; p < 0.0001), or Hispanic (2.4% v. 3.7%; p =.003). Compared to the US NSCLC population, Lung-MAP patients were less likely to be ≥ 65 years (57.2% v. 73.5%; p <.001), female (38.6% v. 47.8%; p <.001), or a racial or ethnic minority (15.5% v. 19.3%; p <.001). Lung-MAP patients were more likely to be from socioeconomically deprived neighborhoods (42.2% vs. 36.5%, p <.001). Among patients aged < 65 years, Lung-MAP enrolled more patients reporting Medicaid/no insurance as their primary insurance (27.6% v. 17.9%; p <.001). Conclusions: Lung-MAP improved access to novel therapeutics for older patients, rural patients, those with Medicaid/no insurance, and patients from socioeconomically deprived areas compared to other NSCLC trials. Lung-MAP enrolled exclusively squamous cell lung cancers from 2014-2018, which explains decreased representation of females. Consistent with prior research, Lung-MAP patients were younger and less diverse compared to the US NSCLC population. Further examination of the underrepresentation of Asian and Hispanic patients in Lung-MAP is required to identify barriers to access and potential solutions. The conduct of a master protocol across multiple locations may improve trial participation for patients with limited access due to area-level (rural, socioeconomic deprivation) or insurance barriers.
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Vaidya, Riha, Joseph M. Unger, Lu Qian, Katherine Minichiello, Roy S. Herbst, David R. Gandara, Joel W. Neal, et al. "Representativeness of patients enrolled in the Lung Cancer Master Protocol (Lung-MAP)." Journal of Clinical Oncology 40, no. 16_suppl (June 1, 2022): 6543. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.6543.
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6543 Background: A major goal of Lung-MAP, a biomarker-driven master protocol conducted within the National Clinical Trials Network of the NCI using a public-private partnership, was to improve access to novel therapeutics. Representative enrollment of patient sub-groups in clinical trials is essential for improving confidence that trial findings are valid and applicable to all patients. We examined the representativeness of patients enrolled in Lung-MAP by demographic and area-level measures compared to patients in other advanced non-small cell lung cancer (NSCLC) trials and with the US NSCLC population. Methods: We analyzed data on patients enrolled to Lung-MAP between 2014-2020 according to sex, age ( < 65 years v. ≥ 65 years), race (White v. Black v. Asian), ethnicity (Hispanic v. not Hispanic), residence (rural v. urban), insurance type (Medicaid or no insurance v. private), and neighborhood socioeconomic deprivation (quintiles of Area Deprivation Index score). Rates were compared to SWOG-led NSCLC trials conducted between 2001-2020 (date range to provide sufficient power) and, where possible, to US NSCLC population rates using Surveillance, Epidemiology, and End Results (SEER) registry data (2014-2018). Two-sided tests of proportions at the 5% level were used for all comparisons. Results: 3,556 patients enrolled to Lung-MAP were compared to 2,267 patients enrolled to SWOG-led NSCLC studies. Lung-MAP patients were more likely to be ≥ 65 years old (57.2% v. 46.7%; p <.001) and from rural areas (17.3% v. 14.3%; p =.002) but less likely to be female (38.6% v. 47.2%; p <.001), Asian (2.7% v. 5.1%; p < 0.0001), or Hispanic (2.4% v. 3.7%; p =.003). Compared to the US NSCLC population, Lung-MAP patients were less likely to be ≥ 65 years (57.2% v. 73.5%; p <.001), female (38.6% v. 47.8%; p <.001), or a racial or ethnic minority (15.5% v. 19.3%; p <.001). Lung-MAP patients were more likely to be from socioeconomically deprived neighborhoods (42.2% vs. 36.5%, p <.001). Among patients aged < 65 years, Lung-MAP enrolled more patients reporting Medicaid/no insurance as their primary insurance (27.6% v. 17.9%; p <.001). Conclusions: Lung-MAP improved access to novel therapeutics for older patients, rural patients, those with Medicaid/no insurance, and patients from socioeconomically deprived areas compared to other NSCLC trials. Lung-MAP enrolled exclusively squamous cell lung cancers from 2014-2018, which explains decreased representation of females. Consistent with prior research, Lung-MAP patients were younger and less diverse compared to the US NSCLC population. Further examination of the underrepresentation of Asian and Hispanic patients in Lung-MAP is required to identify barriers to access and potential solutions. The conduct of a master protocol across multiple locations may improve trial participation for patients with limited access due to area-level (rural, socioeconomic deprivation) or insurance barriers.
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Burd, Amy, Ross L. Levine, Amy S. Ruppert, Alice S. Mims, Uma Borate, Eytan M. Stein, Prapti A. Patel, et al. "Precision Medicine Treatment in Older AML: Results of Beat AML Master Trial." Blood 134, Supplement_1 (November 13, 2019): 175. http://dx.doi.org/10.1182/blood-2019-130201.
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*equal contribution of AB, RLL, BD and JCB Background: Acute myeloid leukemia (AML) is common with increasing age, and older adults with AML rarely achieve long-term remission with chemotherapy. Gene discovery studies in older adults with AML have shown that this malignancy is characterized by a multitude of somatic genomic alterations beginning with initiating somatic events followed by acquisition of collaborative transforming mutations. Despite these important biologic insights, current therapeutic approaches to AML remain limited, particularly in adults ≥ 60 years of age. The Beat AML trial was designed to assess the feasibility of using genetic profiling to assign patients (pts) to molecularly defined, subtype-specific therapies within 7 days of the initial diagnosis in a multi-center clinical trial setting, and to delineate the role of molecularly informed first-line treatment of AML with mechanism based novel therapies. Methods: Treatment-naïve patients with AML were enrolled in this prospective trial which offered accelerated cytogenetic and comprehensive mutational testing within 7 days followed by treatment assignment using these molecular data. Pt eligibility included age ≥ 60 years with non-APML AML, no known CNS leukemia, no prior hypomethylating agent (HMA) therapy and no clinical need for emergent therapy. Eligible pts were profiled by local cytogenetics analysis and using a central next generation sequencing (NGS) assay (Foundation Medicine, Inc.) with all molecular data required for treatment assignment (TA) obtained < 7 days. TA was made centrally using a pre-determined algorithm considering somatic cytogenetic and molecular alterations in the dominant clone, available targeted therapeutics for specific AML subsets, and the likelihood of cure with intensive chemotherapy. Results: From November 2016 to January 2019, 487 pts with a suspected diagnosis of AML had enrolled at 14 clinical sites; 395 were eligible for the study (77% of the patients not eligible for the study had an alternative diagnosis). The median age of eligible patients was 72 years (range: 60 to 92) with 38% being≥ 75 years and 16% with treatment-related AML. From the 395 eligible patients, 374 (94.7%) were centrally assigned to the different cytogenetic/genomic groups within 7 days. The most common groups were TP53 mutated (19%) and marker negative (18%) molecular groups. The Beat AML trial is dynamic by design, thereby allowing different arms to open over time; all trial arms are designed to evaluate for substantial clinical efficacy in small, molecularly defined patient subsets. As shown in Figure 1, 224 patients (57%) had a TA and consented to a BEAT AML sub-study. Of the remaining 171 patients, 103 received standard therapy defined as induction therapy (7+3) or hypomethylation agent (25 before TA and 78 after TA), 28 received an alternative investigational agent (5 before TA and 23 after TA), 38 received palliative care, and 2 had an unknown treatment status and are grouped with the palliative care patients in subsequent analyses; 9 patients died before TA (2 who received standard therapy and 7 in the palliative care group). Demographic, clinical, performance and molecular characteristics were not largely different between pts who elected targeted therapy as part of the BEAT AML trial versus those who elected standard therapy. As shown in Figure 2, the overall survival was significantly longer for patients enrolled in a targeted therapy arm as part of the BEAT AML trial compared to those who elected standard therapy. (p<0.0001). The 30-day estimated death rate was 3.7% (95% CI: 1.9-7.2) for patients electing treatment on a BEAT AML sub-study, 20.4% (95% CI: 13.0-31.2) for those receiving standard therapy, 0% for those receiving an investigational therapy, and 72.6% (95% CI: 57.8-85.7) for the palliative care group. Conclusion: Our data support the feasibility of a rapid precision medicine approach in older patients with previously untreated AML. Patients with AML who elected treatment assigned based upon cytogenetic and molecular alterations in the dominant clone using a novel precision medicine approach had significantly improved overall survival versus those who elected standard of care treatment. Disclosures Levine: Gilead: Consultancy; Prelude Therapeutics: Research Funding; Celgene: Consultancy, Research Funding; Novartis: Consultancy; Isoplexis: Membership on an entity's Board of Directors or advisory committees; Roche: Consultancy, Research Funding; Qiagen: Membership on an entity's Board of Directors or advisory committees; Loxo: Membership on an entity's Board of Directors or advisory committees; Imago Biosciences: Membership on an entity's Board of Directors or advisory committees; C4 Therapeutics: Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria; Lilly: Honoraria. Mims:Abbvie: Membership on an entity's Board of Directors or advisory committees; Agios Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Astellas Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; PTC Therapeutics: Membership on an entity's Board of Directors or advisory committees; Jazz Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees. Borate:Novartis: Consultancy; Takeda: Consultancy; Pfizer: Consultancy; Daiichi Sankyo: Consultancy; AbbVie: Consultancy. Stein:Agios: Consultancy, Membership on an entity's Board of Directors or advisory committees; Astellas Pharma US, Inc: Membership on an entity's Board of Directors or advisory committees; Celgene Corporation: Membership on an entity's Board of Directors or advisory committees; PTC Therapeutics: Membership on an entity's Board of Directors or advisory committees; Syros: Membership on an entity's Board of Directors or advisory committees; Daiichi Sankyo, Inc.: Membership on an entity's Board of Directors or advisory committees; Bioline: Membership on an entity's Board of Directors or advisory committees; Genentech: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Patel:France Foundation: Honoraria; Dava Oncology: Honoraria; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Baer:Takeda: Research Funding; Incyte: Research Funding; Kite: Research Funding; Forma: Research Funding; AI Therapeutics: Research Funding; Abbvie: Research Funding; Astellas: Research Funding. Stock:Daiichi: Membership on an entity's Board of Directors or advisory committees; Agios: Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; Research to Practice: Honoraria; UpToDate: Honoraria; Kite, a Gilead Company: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees. Deininger:Pfizer: Consultancy, Honoraria, Research Funding; Ascentage Pharma: Consultancy, Honoraria; TRM: Consultancy; Sangoma: Consultancy; Fusion Pharma: Consultancy; Adelphi: Consultancy; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Humana: Honoraria; Incyte: Honoraria; Novartis: Honoraria; Sangamo: Consultancy; Blueprint: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Blum:Boehringer Ingelheim: Research Funding; Celgene: Research Funding; Astellas,: Research Funding; Xencor: Research Funding; Forma: Research Funding; AmerisourceBergen: Consultancy. Schiller:Amgen: Other, Research Funding; Agios: Research Funding, Speakers Bureau; Celgene: Research Funding, Speakers Bureau; Constellation Pharmaceutical: Research Funding; Daiichi Sankyo: Research Funding; Eli Lilly and Company: Research Funding; FujiFilm: Research Funding; Genzyme: Research Funding; Gilead: Research Funding; Incyte: Research Funding; J&J: Research Funding; Jazz Pharmaceuticals: Honoraria, Research Funding; Karyopharm: Research Funding; Novartis: Research Funding; Onconova: Research Funding; Pfizer Pharmaceuticals: Equity Ownership, Research Funding; Sangamo Therapeutics: Research Funding; Bristol Myer Squibb: Research Funding; Astellas: Research Funding; Biomed Valley Discoveries: Research Funding. Olin:Daiichi Sankyo: Research Funding; Astellas: Research Funding; Genentech: Consultancy, Research Funding; Pfizer: Research Funding; Jazz Pharmaceuticals: Consultancy, Honoraria; Revolution Medicine: Consultancy; AstraZeneca: Research Funding; Clovis: Research Funding; Ignyta: Research Funding; MedImmune: Research Funding; Mirati Therapeutics: Research Funding; Novartis: Research Funding; Spectrum: Research Funding. Foran:Agios: Honoraria, Research Funding. Lin:Pfizer: Membership on an entity's Board of Directors or advisory committees; Jazz Pharmaceuticals: Honoraria. Traer:AbbVie: Consultancy; Agios: Consultancy; Astellas: Consultancy; Daiichi Sankyo: Consultancy; Notable Labs: Equity Ownership. Odenike:AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Incyte: Research Funding; Astra Zeneca: Research Funding; Astex Pharmaceuticals: Research Funding; NS Pharma: Research Funding; Gilead Sciences: Research Funding; Janssen Oncology: Research Funding; Oncotherapy: Research Funding; Agios: Research Funding; CTI/Baxalta: Research Funding. Arellano:Gilead: Consultancy. Vergilio:Roche Holding AG: Equity Ownership; Foundation Medicine: Employment. Brennan:Foundation Medicine: Employment. Vietz:Foundation Medicine: Employment. Druker:ALLCRON: Membership on an entity's Board of Directors or advisory committees; Pfizer: Research Funding; Aileron Therapeutics: #2573, Constructs and cell lines harboring various mutations in TNK2 and PTPN11, licensing fees , Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Patents & Royalties, Research Funding; Burroughs Wellcome Fund: Membership on an entity's Board of Directors or advisory committees; Cepheid: Consultancy, Honoraria; The RUNX1 Research Program: Membership on an entity's Board of Directors or advisory committees; GRAIL: Equity Ownership, Other: former member of Scientific Advisory Board; Patient True Talk: Consultancy; Dana-Farber Cancer Institute (antibody royalty): Patents & Royalties: #2524, antibody royalty; Pfizer: Other: PI or co-investigator on clinical trial(s) funded via contract with OHSU., Research Funding; Merck & Co: Patents & Royalties: Dana-Farber Cancer Institute license #2063, Monoclonal antiphosphotyrosine antibody 4G10, exclusive commercial license to Merck & Co; OHSU (licensing fees): Patents & Royalties: #2573, Constructs and cell lines harboring various mutations in TNK2 and PTPN11, licensing fees ; Amgen: Equity Ownership, Membership on an entity's Board of Directors or advisory committees; Aptose Biosciences: Consultancy, Equity Ownership, Membership on an entity's Board of Directors or advisory committees; Beta Cat: Membership on an entity's Board of Directors or advisory committees, Other: Stock options; Blueprint Medicines: Consultancy, Equity Ownership, Membership on an entity's Board of Directors or advisory committees; Vivid Biosciences: Membership on an entity's Board of Directors or advisory committees, Other: Stock options; Beat AML LLC: Other: Service on joint steering committee; CureOne: Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy; Gilead Sciences: Other: former member of Scientific Advisory Board; ICON: Other: Scientific Founder of Molecular MD, which was acquired by ICON in Feb. 2019; Monojul: Other: former consultant; Novartis: Other: PI or co-investigator on clinical trial(s) funded via contract with OHSU., Patents & Royalties: Patent 6958335, Treatment of Gastrointestinal Stromal Tumors, exclusively licensed to Novartis, Research Funding; Bristol-Myers Squibb: Other: PI or co-investigator on clinical trial(s) funded via contract with OHSU., Research Funding. Byrd:Novartis: Other: Travel Expenses, Speakers Bureau; BeiGene: Research Funding; Pharmacyclics LLC, an AbbVie Company: Other: Travel Expenses, Research Funding, Speakers Bureau; Acerta: Research Funding; Ohio State University: Patents & Royalties: OSU-2S; Genentech: Research Funding; Gilead: Other: Travel Expenses, Research Funding, Speakers Bureau; TG Therapeutics: Other: Travel Expenses, Research Funding, Speakers Bureau; Janssen: Consultancy, Other: Travel Expenses, Research Funding, Speakers Bureau.
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Rajasekaran, Karthik, Jason G. Newman, Robert G. Maki, Thomas J. Ow, Vikas Mehta, Kenneth R. Gundle, Daniel R. Clayburgh, et al. "Abstract CT216: A phase 0 master protocol utilizing a novel intratumoral microdosing approach for simultaneously evaluating multiple drugs and drug combinations in patients with solid tumors." Cancer Research 82, no. 12_Supplement (June 15, 2022): CT216. http://dx.doi.org/10.1158/1538-7445.am2022-ct216.
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Abstract Purpose/Objectives: Tumor responses to cancer treatments are highly context-specific and often involve complex interactions between the anti-cancer therapy, genetically diverse tumor cells, and a heterogeneous tumor microenvironment (TME). All preclinical models fall short in capturing this complexity. CIVO (Comparative In Vivo Oncology) is an intratumoral microdose injection research tool intended to bridge the translational gap between preclinical and clinical studies by enabling in situ assessment of up to 8 oncology drugs or drug combinations simultaneously within a patient’s tumor. The CIVO Phase 0 model was established under FDA’s exploratory IND guidelines for microdosing. A Master Protocol was then developed, enabling ongoing evaluation of multiple investigational drugs and combinations without a need for stand-alone new protocols. Each investigational drug or combination is specified as a substudy of the Master Protocol, thus reducing administrative burden to clinical site staff and creating an infrastructure to ensure quality data and oversight of patient safety. This is a multi-center, open-label Phase 0 Master Protocol designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the TME when administered intratumorally in microdose quantities via the CIVO device. The safety of intratumoral microdose administration via the CIVO device will also be evaluated. Materials/Methods: Approximately 12 subjects are expected to be enrolled per substudy. All substudies will evaluate subjects ≥18 years with a diagnosis of solid tumors with scheduled surgical intervention. Eligible subjects have at least one lesion (primary or recurrent tumor or effaced metastatic lymph node) ≥2 cm in the shortest diameter that is surface accessible for CIVO injection. Each substudy will define the tumor type and specific eligibility criteria for enrollment. The study visits consist of screening, CIVO injection, surgical intervention, and two follow-up visits. All patients will be injected by the CIVO device containing microdose quantities of drugs specified in respective substudies. The CIVO device can be configured with 3, 5, or 8 needles and the device configuration will be assigned on a per-patient basis, dependent upon lesion size. Following surgical resection, the injected portion of the tumor will undergo central PD biomarker analysis. At the time of submission, the study is open for enrollment with 1 substudy enrolling Head and Neck Squamous Cell Carcinoma (HNSCC) patients and 1 substudy enrolling HNSCC or soft tissue sarcoma patients. The Master Protocol was established to efficiently add substudies and accommodate evaluation of a wider repertoire of new agents in order to continually inform and de-risk drug development via the CIVO platform. Clinical trial information: NCT04541108. Citation Format: Karthik Rajasekaran, Jason G. Newman, Robert G. Maki, Thomas J. Ow, Vikas Mehta, Kenneth R. Gundle, Daniel R. Clayburgh, Ryan J. Li, Mercedes Porosnicu, Cherie-Ann O. Nathan, Alice Tang, Beryl A. Hatton, Kimberly H. Sottero, Gloria Kung, Marc O. Grenley, Kirsten Anderson, Richard A. Klinghoffer. A phase 0 master protocol utilizing a novel intratumoral microdosing approach for simultaneously evaluating multiple drugs and drug combinations in patients with solid tumors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr CT216.
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TERASAWA, Katsutoshi. "What my master says; On the book of “Clinical Note of Kampoh Medicine-a volume of research articles”." Kampo Medicine 37, no. 3 (1987): 221–22. http://dx.doi.org/10.3937/kampomed.37.221.
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Andrews, Abby, Katharine A. Wallis, and Felicity Goodyear-Smith. "Master of Primary Health Care degree: who wants it and why?" Journal of Primary Health Care 8, no. 2 (2016): 106. http://dx.doi.org/10.1071/hc15026.
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Abstract INTRODUCTION The Department of General Practice and Primary Health Care at the University of Auckland is considering developing a Master of Primary Health Care (MPHC) programme. Masters level study entails considerable investment of both university and student time and money. AIM To explore the views of potential students and possible employers of future graduates to discover whether there is a market for such a programme and to inform the development of the programme. METHODS Semi-structured interviews were conducted with 30 primary health care stakeholders. Interviews were digitally recorded, transcribed and analysed using a general inductive approach to identify themes. FINDINGS Primary care practitioners might embark on MPHC studies to develop health management and leadership skills, to develop and/or enhance clinical skills, to enhance teaching and research skills, or for reasons of personal interest. Barriers to MPHC study were identified as cost and a lack of funding, time constraints and clinical workload. Study participants favoured inter-professional learning and a flexible delivery format. Pre-existing courses may already satisfy the post-graduate educational needs of primary care practitioners. Masters level study may be superfluous to the needs of the primary care workforce. CONCLUSIONS Any successful MPHC programme would need to provide value for PHC practitioner students and be unique. The postgraduate educational needs of New Zealand primary care practitioners may be already catered for. The international market for a MPHC programme is yet to be explored.
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Knapke, Jacqueline, Erin N. Haynes, and Lisa M. Vaughn. "Improving physician research training: understanding the student perspective." Studies in Graduate and Postdoctoral Education 11, no. 2 (March 9, 2020): 145–62. http://dx.doi.org/10.1108/sgpe-03-2019-0036.
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Purpose Using a mixed-methods approach, this study evaluated a Master of Science program in Clinical and Translational Research (MSCTR) geared toward training physicians in research methodology. The purpose of this study is to allow trainees to articulate their expectations, needs and experiences in the MSCTR and to develop novel training methods and/or curriculum modifications to improve physician-scholar training. Design/methodology/approach The mixed-method study design with qualitative emphasis included interviews, participant journal entries and a survey. Interview and journal entry data were analyzed using a modified seven-stage hermeneutic analysis and survey data were analyzed using descriptive statistics. Findings Findings suggest three major areas for improvement, namely, curriculum, mentorship/relationships and instructional methods. Concluding recommendations to address these three areas include: make ongoing curriculum updates to provide a sequential pathway but also allow for flexibility, improve statistical training, invest in online courses and create a more structured mentorship program. Originality/value Extant research, though minimal, has evaluated clinical research training programs in terms of alumni productivity. However, this is the first study of its kind to examine a clinical research training program primarily qualitatively and from the perspective of its students and alumni.
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Žufková, Viera, Ján Klimas, Ján Kyselovič, Michal Vivoda, and Marián Šuráb. "ETHICS IN CLINICAL RESEARCH: IS ETHICS INVOLVED INTO THE PHARMACY STUDIES IN EUROPE?" CBU International Conference Proceedings 1 (June 30, 2013): 347–53. http://dx.doi.org/10.12955/cbup.v1.56.
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One of the key questions in medicine nowadays is the ethics and its maximum involvement into medical profession. The absence of ethics is very notable in public and professional relations. In spite of the fact that the pharmacy profession was separated from the medical profession in the 13th century by the emperor Frederic II, the ethics is involved into pharmacy study in minimum amount. In the article there is presented the ethics inclusion into pharmacy study in 31 Universities of the European Union (EU). The method of our research was the analysis of 31 WebPages of Faculties of Pharmacy in the EU. The ethics is taught in the 45% study programmes. It is mostly a part of syllabus of master programme (Czech Republic, Estonia and Portugal) or bachelor programme (Slovakia). We have not managed to find a full study plan in 13% of study plans. As the ethics remains the crucial part of the pharmacy profession, there is a great importance of its involvement into the pharmacy study. The Code of Conduct for Pharmacy students with its seven principles shall be a part of ethical preparation of future pharmacists in Europe.
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Russi, Sabino, Luigi Marano, Simona Laurino, Giovanni Calice, Dario Scala, Graziella Marino, Alessandro Sgambato, et al. "Gene Regulatory Network Characterization of Gastric Cancer’s Histological Subtypes: Distinctive Biological and Clinically Relevant Master Regulators." Cancers 14, no. 19 (October 10, 2022): 4961. http://dx.doi.org/10.3390/cancers14194961.
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Gastric cancer (GC) molecular heterogeneity represents a major determinant for clinical outcomes, and although new molecular classifications have been introduced, they are not easy to translate from bench to bedside. We explored the data from GC public databases by performing differential gene expression analysis (DEGs) and gene network reconstruction to identify master regulators (MRs), as well as a gene set analysis (GSA) to reveal their biological features. Moreover, we evaluated the association of MRs with clinicopathological parameters. According to the GSA, the Diffuse group was characterized by an epithelial-mesenchymal transition (EMT) and inflammatory response, while the Intestinal group was associated with a cell cycle and drug resistance pathways. In particular, the regulons of Diffuse MRs, such as Vgll3 and Ciita, overlapped with the EMT and interferon-gamma response, while the regulons Top2a and Foxm1 were shared with the cell cycle pathways in the Intestinal group. We also found a strict association between MR activity and several clinicopathological features, such as survival. Our approach led to the identification of genes and pathways differentially regulated in the Intestinal and Diffuse GC histotypes, highlighting biologically interesting MRs and subnetworks associated with clinical features and prognosis, suggesting putative actionable candidates.
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Yilin, Teng, Cao Gaofang, and Wang Rui. "Big Data in Medical Research and Application." MATEC Web of Conferences 176 (2018): 03017. http://dx.doi.org/10.1051/matecconf/201817603017.
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With the advanced instruments and information technology integrated in biomedical science more and more extensively, the advent of the big data era has had a significant impact on biomedical research, making human awareness of themselves and diseases more profound. The future medicine tends to combine data and medicine, to master gene database and medical human disease data, then to apply data statistics and analysis and application in healthcare. New techniques of big data in medicine are bound to make medical research and application more predictable. This paper introduces the main sources and characteristics of medical big data, points out the necessity of big data research in medical field, summarizes the current research in medical big data and its application in disease prediction, clinical assistance and pharmaceutical research and development. In other aspects, it analyses the problems of medical big data in applied research.
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Hepburn, A. C., R. E. Steele, R. Veeratterapillay, L. Wilson, E. E. Kounatidou, A. Barnard, P. Berry, et al. "Correction: The induction of core pluripotency master regulators in cancers defines poor clinical outcomes and treatment resistance." Oncogene 38, no. 22 (May 2019): 4425. http://dx.doi.org/10.1038/s41388-019-0826-2.
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