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Lund, Jennifer L., Michael A. Webster-Clark, Daniel Westreich, Hanna K. Sanoff, Nicholas Robert, Jennifer R. Frytak, Marley Boyd, Shahar Shmuel, Til Stürmer i Alexander P. Keil. "Visualizing External Validity: Graphical Displays to Inform the Extension of Treatment Effects from Trials to Clinical Practice". Epidemiology 35, nr 2 (30.01.2023): 241–51. http://dx.doi.org/10.1097/ede.0000000000001694.
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Background: In the presence of effect measure modification, estimates of treatment effects from randomized controlled trials may not be valid in clinical practice settings. The development and application of quantitative approaches for extending treatment effects from trials to clinical practice settings is an active area of research. Methods: In this article, we provide researchers with a practical roadmap and four visualizations to assist in variable selection for models to extend treatment effects observed in trials to clinical practice settings and to assess model specification and performance. We apply this roadmap and visualizations to an example extending the effects of adjuvant chemotherapy (5-fluorouracil vs. plus oxaliplatin) for colon cancer from a trial population to a population of individuals treated in community oncology practices in the United States. Results: The first visualization screens for potential effect measure modifiers to include in models extending trial treatment effects to clinical practice populations. The second visualization displays a measure of covariate overlap between the clinical practice populations and the trial population. The third and fourth visualizations highlight considerations for model specification and influential observations. The conceptual roadmap describes how the output from the visualizations helps interrogate the assumptions required to extend treatment effects from trials to target populations. Conclusions: The roadmap and visualizations can inform practical decisions required for quantitatively extending treatment effects from trials to clinical practice settings.
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Baum, Michael. "Limitations of Nonscience in Surgical Epistemology: The Second-Look Laparotomy". International Journal of Technology Assessment in Health Care 5, nr 3 (lipiec 1989): 381–88. http://dx.doi.org/10.1017/s0266462300007443.
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Decision-making in medicine is a very complex process that demands input both from the doctor and from the client. From the doctor's point of view, the most important component for this decision concerns the quality of evidence available that the recommended intervention is the best available in terms of both cost and benefit. Good quality evidence demands good quality science. The randomized controlled trial is the expression of this scientific process at work within medical practice. This article reviews both the rationale and the ethics of randomized controlled trials in the epistemology of surgery. The ethical dilemma is accentuated because surgery by its very nature is invasive and often irreversible. As an illustration of the scientific and ethical dilemmas arising out of randomized controlled trials in surgery, a description of the CEA directed second-look laparotomy trial in the United Kingdom is provided. This trial may be judged essential because of the clash of attitudes between surgeons in the United States and the United Kingdom. It is unlikely that the truth lies entirely with one or other national groupings of surgeons, and this randomized trial will eventually resolve a conflict of ideas to the ultimate benefit of all patients with operable colorectal cancer.
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Frelick, R. W. "The Community Clinical Oncology Program (CCOP) story: review of community oncologists' experiences with clinical research trials in cancer with an emphasis on the CCOP of the National Cancer Institute between 1982 and 1987." Journal of Clinical Oncology 12, nr 8 (sierpień 1994): 1718–23. http://dx.doi.org/10.1200/jco.1994.12.8.1718.
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PURPOSE To review the growth of community physicians' involvement in National Cancer Institute (NCI) clinical research trials as a significant contribution to cancer control, and to show their impact, not yet fully realized, on cancer morbidity and mortality in the United States. DESIGN Background information, based on the personal experience of participants, as well as a review of pertinent literature, portrays the evolution of the clinical research component of community oncology in the United States over the last 25 years. RESULTS Data from Community Clinical Oncology Programs (CCOPs) I and II have been used to outline some of the results of this far-reaching program. CONCLUSION The CCOP was introduced at an appropriate time to expand the clinical trial resources of the NCI, while at the same time helping community oncologists practice state-of-the-art cancer management found in the research protocols. This in turn provided improved resources to manage cancer patients, as most of them are treated in their own communities. CCOPs have also indirectly had a positive impact on the trial processes of the NCI cooperative groups and comprehensive cancer centers, and have helped to widen the scope and hasten progress in cancer-control research and practice.
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Potter, Danielle, Raven Brothers, Andrej Kolacevski, Jacob E. Koskimaki, Amy McNutt, Robert S. Miller, Jatin Nagda i in. "Development of CancerLinQ, a Health Information Learning Platform From Multiple Electronic Health Record Systems to Support Improved Quality of Care". JCO Clinical Cancer Informatics, nr 4 (październik 2020): 929–37. http://dx.doi.org/10.1200/cci.20.00064.
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PURPOSE ASCO, through its wholly owned subsidiary, CancerLinQ LLC, developed CancerLinQ, a learning health system for oncology. A learning health system is important for oncology patients because less than 5% of patients with cancer enroll in clinical trials, leaving evidence gaps for patient populations not enrolled in trials. In addition, clinical trial populations often differ from the overall cancer population with respect to age, race, performance status, and other clinical parameters. MATERIALS AND METHODS Working with subscribing practices, CancerLinQ accepts data from electronic health records and transforms the local representation of a patient’s care into a standardized representation on the basis of the Quality Data Model from the National Quality Forum. CancerLinQ provides this information back to the subscribing practice through a series of tools that support quality improvement. CancerLinQ also creates de-identified data sets for secondary research use. RESULTS As of March 2020, CancerLinQ includes data from 63 organizations across the United States that use nine different electronic health records. The database includes 1,426,015 patients with a primary cancer diagnosis, of which 238,680 have had additional information abstracted from unstructured content. CONCLUSION As CancerLinQ continues to onboard subscribing practices, the breadth of potential applications for a learning health care system widen. Future practice-facing tools could include real-world data visualization, recommendations for treatment of patients with actionable genetic variations, and identification of patients who may be eligible for clinical trials. Feeding these insights back into oncology practice ensures that we learn how to treat patients with cancer not just on the basis of the selective experience of the 5% that enroll in clinical trials, but from the real-world experience of the entire spectrum of patients with cancer in the United States.
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Mousaei Ghasroldasht, Mohammad, Jin Seok, Hang-Soo Park, Farzana Begum Liakath Ali i Ayman Al-Hendy. "Stem Cell Therapy: From Idea to Clinical Practice". International Journal of Molecular Sciences 23, nr 5 (5.03.2022): 2850. http://dx.doi.org/10.3390/ijms23052850.
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Regenerative medicine is a new and promising mode of therapy for patients who have limited or no other options for the treatment of their illness. Due to their pleotropic therapeutic potential through the inhibition of inflammation or apoptosis, cell recruitment, stimulation of angiogenesis, and differentiation, stem cells present a novel and effective approach to several challenging human diseases. In recent years, encouraging findings in preclinical studies have paved the way for many clinical trials using stem cells for the treatment of various diseases. The translation of these new therapeutic products from the laboratory to the market is conducted under highly defined regulations and directives provided by competent regulatory authorities. This review seeks to familiarize the reader with the process of translation from an idea to clinical practice, in the context of stem cell products. We address some required guidelines for clinical trial approval, including regulations and directives presented by the Food and Drug Administration (FDA) of the United States, as well as those of the European Medicine Agency (EMA). Moreover, we review, summarize, and discuss regenerative medicine clinical trial studies registered on the Clinicaltrials.gov website.
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STAHN, CARSTEN, i VOLKER NERLICH. "The International Criminal Court and Co-operation: Introductory Note". Leiden Journal of International Law 21, nr 2 (czerwiec 2008): 429–30. http://dx.doi.org/10.1017/s0922156508005013.
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Co-operation has proved to be one of the greatest challenges in the first practice of the International Criminal Court (ICC). The Court cannot fulfil its mandate effectively without co-operation from states, international organizations, and other actors. The Prosecutor requires co-operation and assistance at various stages of proceedings (preliminary examination, investigation, judicial proceedings) in order to conduct investigations and prosecutions. The Court depends on the co-operation of states to execute the warrants of arrest and proceed to trial. In the context of its first practice, the Court has operated in situations of ongoing conflict and/or environments where the security situation is volatile. The level and modalities of co-operation were influenced by the factual and political conditions on the ground and the institutional support of other entities (e.g. the United Nations).
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Szasz, Thomas. "1. Psychiatric Justice". British Journal of Psychiatry 154, nr 6 (czerwiec 1989): 864–69. http://dx.doi.org/10.1192/bjp.154.6.864.
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It is now widely accepted, especially in the United States, that confining lawbreakers in mental hospitals as insane, without the benefit of a real trial, rather in prisons as criminals, after a proper trial, is a recent, enlightened Western practice. Nothing could be further from the truth. The practice is not recent, enlightened, or typically Western – resembling the Oriental despotic arbitrariness towards troublesome persons much more closely than the Occidental legal respect towards persons accused of crimes. Many 19th-century cases illustrate the procedure and support my foregoing interpretation of it. The following is a typical example.
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Heilbrun, Kirk, i Greg M. Kramer. "Involuntary medication, trial competence, and clinical dilemmas: Implications of Sell v. United States for psychological practice." Professional Psychology: Research and Practice 36, nr 5 (2005): 459–66. http://dx.doi.org/10.1037/0735-7028.36.5.459.
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GYAMFI-BANNERMAN, CYNTHIA. "Antenatal Late Preterm Steroids: The Evolution of the ALPS Trial". Clinical Obstetrics & Gynecology 67, nr 2 (29.04.2024): 399–410. http://dx.doi.org/10.1097/grf.0000000000000865.
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The Antenatal Late Preterm Steroids (ALPS) trial was designed to address respiratory morbidity common in infants born late preterm. The study was published in April, 2016 and, shortly thereafter, changed clinical practice in obstetrics in the United States. The following chapter describes the ALPS trial study design in detail, including the background leading to the trial, the study outcomes, and the initial findings of the long-term follow-up study. The ALPS story would not be complete without Elizabeth Thom, PhD, who died before her time. Her brilliance largely contributed to the design of the ALPS trial.
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Smith, T. J., B. E. Hillner, N. Schmitz, D. C. Linch, P. Dreger, A. H. Goldstone, M. A. Boogaerts i in. "Economic analysis of a randomized clinical trial to compare filgrastim-mobilized peripheral-blood progenitor-cell transplantation and autologous bone marrow transplantation in patients with Hodgkin's and non-Hodgkin's lymphoma." Journal of Clinical Oncology 15, nr 1 (styczeń 1997): 5–10. http://dx.doi.org/10.1200/jco.1997.15.1.5.
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PURPOSE High-dose chemotherapy (HDC) with peripheral-blood progenitor cell (PBPC) and autologous bone marrow (ABM) transplant (T) has documented survival benefits for relapsed Hodgkin's disease (HD) and non-Hodgkin's lymphoma (NHL). Treatment costs associated with HDC and its supportive care have restricted its use both on and off clinical trial. In a prospective randomized clinical trial, filgrastim-mobilized PBPCT resulted in faster recovery of bone marrow function, with less hospitalization and supportive care than ABMT. This study was undertaken to analyze the costs of the two strategies using prospectively collected data from a randomized clinical trial that compared filgrastim-mobilized PBPCT versus ABMT. PATIENTS AND METHODS Clinical results and resource utilization from a randomized clinical trial that compared filgrastim-mobilized PBPCT versus ABMT following carmustine, etoposide, cytarabine, and melphalan (BEAM) HDC for HD and NHL are presented. The trial was performed in six centers in Germany, the United Kingdom, and Belgium. Resource utilization data were used to project costs and Massay Cancer Center (MCC) in the United States incurred the cost of treating the cohort. Costs were projected to the United States, because the economic implications to United States centers are significant, costs of care vary markedly among countries but resource utilization on this trial did not, and a randomized trial is unlikely to be performed in the United States. RESULTS Fifty-eight patients with relapsed HD or NHL underwent HDC with BEAM. The PBPCT and ABMT groups had similar short-term survival after BEAM. PBPCT patients had a shorter hospitalization (median, 17 v 23 days; P = .002), neutrophil recovery (11 v 14 days; P = .005), platelet recovery to > or = 20 x 10(9)/L (16 v 23 days; P = .02), and days of platelet transfusions (6 v 10; P < .001). Estimated costs were $8,531 for ABM harvest and $5,760 for PBPC collection, including filgrastim mobilization. The total estimated average cost was $59,314 for each ABMT patient versus $45,792 for each PBPCT patient. Cost savings of $13,521 (23%) were due to shorter hospitalizations with less supportive care. CONCLUSION PBPCT is as safe and more effective than ABMT for HD and NHL in the short term. PBPCT represents a significant cost savings due to lower autograft collection costs, shorter hospital stays, and less supportive care. The savings exceed the costs for filgrastim mobilization and PBPC collection. Actual savings will vary depending on local practice patterns, charges, and costs.
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Berch, V. V. "THE CONSTITUTIONAL RIGHT TO A JURY TRIAL AND A FAST TRIAL: THE EXPERIENCE OF THE UNITED STATES". Analytical and Comparative Jurisprudence, nr 2 (6.07.2021): 11–13. http://dx.doi.org/10.24144/2788-6018.2021.02.2.
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The article is devoted to the consideration of the constitutional right to a trial by a jury, as well as the right to a speedy trial in accordance with the provisions of the Sixth Amendment to the US Constitution. It is noted that as of today in Ukraine there is a question of ensuring the actual (real) participation of the people in the administration of justice and the creation of an appropriate mechanism for the realization of such a right of the people. It is established that the permanent evolution of the jury trial in the world as a full-fledged element of participatory democracy allows us to assert the possibility of applying the best foreign experience in this area and for Ukraine. It is noted that the jury trial, which is typical for the United States, is undoubtedly a consequence of the borrowing of English legal customs, but has its own special features. It has been established that the right to a speedy trial should be distinguished from other constitutional rights, as it concerns the interests of society and the justice system more than the interests of the accused. The circumstances that suggest whether a trial is in fact "fast" are rather vague, as each such proceeding is to some extent unique. The requirements for members of the jury are set out in the Jury Selection Act. It is noted that the release of jurors varies depending on the state. One of the grounds for such dismissal is professional activity. For example, doctors, lawyers, public figures, police or firefighters. At the same time, this practice is gradually ceasing to be natural. It is concluded that the jury trial as a form of public participation in the administration of justice is undoubtedly a democratic legal institution. Direct democracy in the exercise of judicial power, which is carried out in compliance with the principles of publicity and adversarial proceedings promotes the establishment of citizens' faith in the fairness of judicial decisions.
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Wang, Zhe, Yifan Lin i Yajing Zhour. "Judicial judgment of ‘Malicious Incompatibility’: based on the study of Chinese judicial practice". Queen Mary Journal of Intellectual Property 10, nr 3 (15.09.2020): 376–91. http://dx.doi.org/10.4337/qmjip.2020.03.05.
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How to judge the formation of Malicious Incompatibility is a problem that cannot be circumvented and is difficult to solve in the trial of new types of unfair competition on the Internet. Although the revised Anti-Unfair Competition Law explicitly stipulates Malicious Incompatibility as unfair competition, it fails to provide a clear set of judgment criteria. Germany and the United States have respectively developed complete laws and regulations and created judgment rules to deal with new unfair competition disputes arising in the development of the Internet, providing China with a lot of referential trial ideas. By collecting and analyzing the judgment documents and trial ideas of previous cases, this paper, focusing on the internal logic of malice and incompatibility in the law, tries to judge whether the behavior constitutes Malicious Incompatibility considered from the perspective of subjective purposes and the objective effects caused by the behavior and with the method of value measurement.
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Krein, Sarah L., Christine P. Kowalski, Laura Damschroder, Jane Forman, Samuel R. Kaufman i Sanjay Saint. "Preventing Ventilator-Associated Pneumonia in the United States: A Multicenter Mixed-Methods Study". Infection Control & Hospital Epidemiology 29, nr 10 (październik 2008): 933–40. http://dx.doi.org/10.1086/591455.
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Objective.To determine what practices are used by hospitals to prevent ventilator-associated pneumonia (VAP) and, through qualitative methods, to understand more fully why hospitals use certain practices and not others.Design.Mixed-methods, sequential explanatory study.Methods.We mailed a survey to the lead infection control professionals at 719 US hospitals (119 Department of Veterans Affairs [VA] hospitals and 600 non-VA hospitals), to determine what practices are used to prevent VAP. We then selected 14 hospitals for an in-depth qualitative investigation, to ascertain why certain infection control practices are used and others not, interviewing 86 staff members and visiting 6 hospitals.Results.The survey response rate was 72%; 83% of hospitals reported using semirecumbent positioning, and only 21% reported using subglottic secretion drainage. Multivariable analyses indicated collaborative initiatives were associated with the use of semirecumbent positioning but provided little guidance regarding the use of subglottic secretion drainage. Qualitative analysis, however, revealed 3 themes: (1) collaboratives strongly influence the use of semirecumbent positioning but have little effect on the use of subglottic secretion drainage; (2) nurses play a major role in the use of semirecumbent positioning, but they are only minimally involved with the use of subglottic secretion drainage; and (3) there is considerable debate about the evidence supporting subglottic secretion drainage, despite a meta-analysis of 5 randomized trials of subglottic secretion drainage that generally supported this preventive practice, compared with only 2 published randomized trials of semirecumbent positioning, one of which concluded that it was ineffective at preventing the development of VAP.Conclusion.Semirecumbent positioning is commonly used to prevent VAP, whereas subglottic secretion drainage is used far less often. We need to understand better how evidence related to prevention practices is identified, interpreted, and used to ensure that research findings are reliably translated into clinical practice.
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Lechner, Matt, Liam Sutton, Mark Ferguson, Yasmin Abbas, Jaswinder Sandhu i Azhar Shaida. "Intratympanic Steroid Use for Sudden Sensorineural Hearing Loss: Current Otolaryngology Practice". Annals of Otology, Rhinology & Laryngology 128, nr 6 (15.02.2019): 490–502. http://dx.doi.org/10.1177/0003489419828759.
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Objective: To investigate the current practice of intratympanic steroid (ITS) injection for sudden sensorineural hearing loss (SSNHL) in the United Kingdom and link the data with data from the United States and continental Europe. Methods: A survey of 21 questions was distributed to members of the British Society of Otology using an online survey platform via ENT UK. Data obtained from UK otolaryngologists (n = 171) were integrated with previously published data from other countries, including the United States (n = 63) and continental Europe (n = 908). Results: In the United Kingdom, 62% of responding otolaryngologists use ITS injection for SSNHL, while 38% do not. Of those using ITS, 59% use it as first-line treatment, either using it in conjunction with oral steroids (51%) or using it as monotherapy (8%). Of those that use ITS, a majority (83%) use it as salvage therapy when primary treatment with systemic steroids has failed, and similar results are found in the continental Europe and US surveys. The most commonly used preparation is dexamethasone. Responses to questions regarding treatment regimes used are enlightening and show considerable variation in the treatment regimes used within and between countries. Conclusions: There is a wide variation in practice with regards to ITS for SSNHL hearing loss in the United Kingdom, United States, and continental Europe. In the absence of protocols or definitive guidance from published literature, knowledge of contemporary practice may help guide or encourage reevaluation of clinical practice and will help guide the design of future clinical trials.
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Gjyshi, Olsi, Ethan B. Ludmir, Todd A. Pezzi, David Boyce-Fappiano, Timur Mitin i Steven H. Lin. "Nationwide shift in patterns of prophylactic cranial irradiation utilization for extensive-stage small cell lung cancer patients." Journal of Clinical Oncology 37, nr 15_suppl (20.05.2019): e20099-e20099. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e20099.
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e20099 Background: A recent phase III trial (Takahashi et al., 2017) showed no overall survival (OS) benefit in patients with extensive-stage small cell lung cancer (ES-SCLC) treated with prophylactic cranial irradiation (PCI), casting doubt on the practice of PCI as established in a prior phase III trial (Slotman et al., 2007). We undertook a nationwide survey of radiation oncologists to ascertain the impact of the Takahashi trial on the utilization of PCI for ES-SCLC patients. Methods: A total of 3,646 ASTRO-registered radiation oncologists in the United States were invited to answer an anonymous survey on their use of PCI in ES-SCLC, and the impact of the recent Takahashi et al. trial on their practice. The survey consisted of 35 questions created using a branching logic system via RedCAP. Results: A total of 438 (12%) radiation oncologists completed the survey. Responders were well-distributed across geographic regions, practice environment, age, gender, practice size and lung cancer volume. Most respondents (92%) were aware of the Takahashi trial. While 71% routinely offered PCI to ES-SCLC patients prior to the publication of this trial, only 43% continue to do so after its publication (p < 0.001). Most respondents (66%) had altered their practice in response to the study. There was no difference in post-publication practice patterns between academic and private practice radiation oncologists (43% vs. 44%, p = 0.81). While 43% of participants who were aware of the Takahashi trial still offered PCI after its publication, 82% of those unaware of the trial still continued to offer PCI (p < 0.001). Additionally, 25% of participants noted that they have experienced a decrease in medical oncology referrals for PCI for ES-SCLC patients. Twenty-two percent of participants stated that the Takahashi trial impacted their practice with regards to limited-stage SCLC patients as well. Looking toward the future, 47% of respondents reported that they would be willing to enroll both LS- and ES-SCLC patients on a randomized trial comparing active MRI-surveillance to PCI; 15% stated that they would enroll only LS-SCLC patients on such a trial, and 20% would enroll only ES-SCLC patients. Conclusions: The phase III data from Takahashi et al. (2017) has markedly impacted the current practice patterns in the US by reducing PCI utilization for ES-SCLC patients across all practice settings and measured demographic variables. Most respondents expressed openness to a randomized trial comparing active MRI surveillance to PCI for SCLC patients.
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Moore, M. J., B. O'Sullivan i I. F. Tannock. "How expert physicians would wish to be treated if they had genitourinary cancer." Journal of Clinical Oncology 6, nr 11 (listopad 1988): 1736–45. http://dx.doi.org/10.1200/jco.1988.6.11.1736.
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A questionnaire describing six clinical scenarios was mailed to urologists (in Britain, Canada, and the United States) and to radiation and medical oncologists in the United States, who practice genito-urinary (GU) oncology. In each scenario, the surgeon or physician was asked to consider himself as a patient with bladder, prostate, or kidney cancer, and to select his own treatment. Accompanying each scenario were one or two clinical trials for which the physician would be eligible. He was asked to state if he would agree to be randomized in each trial, and if he refused, to state his reasons. We found that (1) there were major differences of opinion about management for each scenario; (2) choice of treatment was influenced more by specialty training or geographic location than by the results of previous clinical trials (which are available to all); (3) British urologists tended to be less aggressive than their North American colleagues, with respect to the use of radical surgery and chemotherapy; (4) acceptance of clinical trials ranged from 3% to 60%; and (5) agreement to clinical trials was quite poor even when they were designed to compare the most popular options for management. This physician surrogate method is a valuable tool in assessment of the degree of consensus amongst expert physicians and in the determination of whether new clinical trials address important areas of controversy.
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Harari, P. M. "Why has induction chemotherapy for advanced head and neck cancer become a United States community standard of practice?" Journal of Clinical Oncology 15, nr 5 (maj 1997): 2050–55. http://dx.doi.org/10.1200/jco.1997.15.5.2050.
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PURPOSE Induction chemotherapy for advanced head and neck (H&N) cancer has been studied in clinical trials for more than two decades without clear demonstration of benefit for locoregional tumor control or overall patient survival. Nonetheless, its use has become a common community standard of practice in the United States (US). This report examines some of the factors that may have contributed to this phenomenon. MATERIALS AND METHODS A mail survey was conducted of 300 US community cancer specialists (equally divided among otolaryngologists, radiation oncologists, and medical oncologists) to solicit their most frequent therapy approach for patients with locoregionally advanced, nonmetastatic H&N cancer. The rationale for selection of treatment strategy was identified by each respondent. RESULTS Two hundred eighteen physicians (73%) completed and returned the survey, representing 47 US states. The single most common treatment approach reported for patients with locoregionally advanced H&N cancer was that of sequential chemoradiation (61%), specifically, induction chemotherapy with fluorouracil (5-FU)/cisplatin followed by radiation therapy. Four percent of respondents indicated that induction chemotherapy was administered within the context of a controlled clinical trial, whereas 96% indicated that therapy was administered off study. The primary objectives cited by respondents for the use of induction chemotherapy included the desire to improve locoregional tumor control (67%), to improve overall survival (56%), to maintain a spirit of multidisciplinary care (34%), to improve quality of life (29%), and to decrease distant metastases (26%). CONCLUSION Review of the published trials between 1970 and 1995 and of the published meta-analyses show no clear evidence for an improvement in locoregional tumor control or survival for H&N cancer patients treated with 5-FU/cisplatin induction chemotherapy regimens. Nonetheless, this induction chemotherapy approach for advanced H&N cancer patients has become a dominant community practice in the US. Factors that may have contributed to this paradox are reviewed.
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Kim, Edward Kangsuhp, William James Fletcher i Clark Timothy Johnson. "Effect of Increasing Malpractice Insurance Cost and Subsequent Practice of Defensive Medicine on Out-of-Hospital Birth Rates in the United States". American Journal of Perinatology 36, nr 07 (29.10.2018): 723–29. http://dx.doi.org/10.1055/s-0038-1675156.
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Background Across the United States, the burden of malpractice litigation has influenced obstetricians and obstetric institutions to avoid high-risk patients, favor cesarean delivery, and decrease availability of trial of labor after cesarean. Recently, the United States has experienced an increase in out-of-hospital (OOH) births. Objective The main purpose of this article is to investigate the association between malpractice insurance premium (MIP) and OOH births in the United States from 2000 to 2014. Study Design We analyzed changes in OOH birth rates and MIP from 2000 to 2014 using birth data from the National Vital Statistics System and Medical Liability Monitor's annual survey, respectively. The change in OOH birth rates was then compared with the change in MIP. Results Between 2000 and 2014, there has been approximately 60% increase in MIP from national average of $40,949 to $65,210 (p < 0.05). OOH births increased 57% from 39,398 births to 59,674 births (p < 0.05). There was a significant positive correlation between increase in MIP and increase in OOH births (p < 0.05, R 2 = 0.14). Conclusion MIP and OOH birth rates have a significantly associated increase from 2000 to 2014. Given that malpractice climate affects other aspects of obstetric practice, we cautiously propose that increasing MIP may be associated with an increase in OOH births.
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Ryan, Patricia Y., Julia M. Brain, Sara I. Pai, H. Kim Lyerly i Jennifer Lynn Harris. "A new model to enhance enrollment of diverse participants to therapeutic clinical trials." Journal of Clinical Oncology 42, nr 16_suppl (1.06.2024): TPS1640. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.tps1640.
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TPS1640 Background: Disparities in United States clinical trial participation are well described, with the inclusion of only 8% Black, 6% Asian, and 1% Hispanic participants in phase III oncology trials supporting US FDA filings in 2020. The FDA, Cancer Moonshot, and ASCO-ACCC have issued guidance, sponsored initiatives, and developed strategies to raise awareness around the importance of equality, diversity, and inclusion at centers with current clinical research capabilities. Centers with ongoing research capability are typically large academic or private practice sites located in urban areas. There is an urgent need to expand clinical trial offerings to rural communities as geographic constraints disproportionally limit people of color and people of low socioeconomic status from accessing innovative drugs offered only through clinical trials. An additional contributing factor to low enrollment of diverse participants is a lack of racial, ethnic, gender, and geographic diversity amongst clinical trial investigators, who may be more relatable and, thus, effective at recruiting underrepresented patients to clinical trials. Lastly, to provide high quality care for their patients, clinical investigators must have ability to identify and select trials which address the specific needs of the patients within their practice. We hypothesize that a tool which improves identification and inclusion of an expanded investigator pool will result in improved diversity of clinical trial participation. Methods: We have developed a bi-directional matching software program that allows healthcare providers to define their areas of interest and match them to available pharmaceutical company clinical trial opportunities. The software, Golgi-CONNECT, will be piloted with up to 500 oncology-focused healthcare providers across a diverse geographic landscape and up to 6 pharmaceutical companies of varying sizes to evaluate the functionality and usability of the application. Additionally, HCP-reported barriers to clinical trial conduct, inclusive of financial, infrastructure, training, mentoring and lack of support staff will be collected.
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Resnick, Trevor, Alexis Arzimanoglou, Lawrence W. Brown, Robert Flamini, Michael Kerr, Gerhard Kluger, Sanjeev Kothare, Sunny Philip, Miranda Harrison i Milind Narurkar. "Rufinamide from clinical trials to clinical practice in the United States and Europe". Epileptic Disorders 13, S1 (maj 2011): 27–43. http://dx.doi.org/10.1684/epd.2011.0421.
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Dunbar, Adam. "Art or Confession?: Evaluating Rap Lyrics as Evidence in Criminal Cases". Race and Justice 10, nr 3 (23.01.2018): 320–40. http://dx.doi.org/10.1177/2153368717749879.
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For decades, scholars have studied mechanisms that might explain racial disparities in the criminal justice system. One novel example of a practice that may contribute to continuing disparities is the introduction of defendant-authored rap lyrics as evidence in criminal trials. Across the United States, prosecutors are introducing rap lyrics as confession evidence to establish guilt. Concerns about this practice have been articulated by scholars and others but rarely empirically examined. This study begins to address this lacuna. In particular, this study examines how lyrics are evaluated when presented in a trial context and determines how individuals change their evaluations of the lyrics to support their verdict. Participants were tasked with evaluating evidence, including rap lyrics, independently and in the context of a trial and then rendering a verdict. Results indicate that rap lyrics are viewed as interdependent with other evidence when presented at trial. Furthermore, although evaluations of lyrics did not predict determinations of guilt, verdict affected whether the lyrics were evaluated as a confession, and this effect was stronger for participants who believed the defendant was guilty. These findings highlight how introducing rap lyrics might disproportionately advantage prosecutors and contribute to our understanding of racial disparities in the criminal justice system.
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Wood, Ellen, Paul Harpur i Nancy Pachana. "Teaching an old dog new tricks: Using courthouse facility dogs in Australia". Alternative Law Journal 43, nr 2 (czerwiec 2018): 89–95. http://dx.doi.org/10.1177/1037969x18767694.
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Courthouse facility dogs are increasingly used to support child witnesses and complainants during testimony in courtrooms across the globe. Although already commonplace in the United States, this practice has been largely unexplored in the Australian context. This paper puts forward the case for courthouse facility dogs in Australia and offers some insight into striking the delicate balance between protecting defendants’ rights to a fair trial, and improving the efficiency and quality of the legal system for vulnerable witnesses and victims.
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Qureshi, Adnan I., Gabriela Vazquez, Nauman Tariq, M. Fareed K. Suri, Kamakshi Lakshminarayan i Giuseppe Lanzino. "Impact of International Subarachnoid Aneurysm Trial results on treatment of ruptured intracranial aneurysms in the United States". Journal of Neurosurgery 114, nr 3 (marzec 2011): 834–41. http://dx.doi.org/10.3171/2010.6.jns091486.
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Object The utilization of endovascular treatment for ruptured intracranial aneurysms is expected to change since the publication of the International Subarachnoid Aneurysm Trial (ISAT) in 2002. The authors performed this analysis to determine the impact of ISAT results on treatment selection for ruptured intracranial aneurysms and associated in-hospital outcomes using nationally representative data. Methods We determined the national estimates of treatments used for ruptured intracranial aneurysms and associated in-hospital outcomes, length of stay, mortality, and cost incurred using the Nationwide Inpatient Survey (NIS) data. The NIS is the largest all-payer inpatient care database in the US and contains data from 986 hospitals approximating a 20% stratified sample of US hospitals. All the variables pertaining to hospitalization were compared between 2000–2002 and 2004–2006, and in-hospital outcomes were analyzed using multivariate analysis. Results In the 3-year periods prior to and after the ISAT, there were 70,637 and 77,352 admissions for ruptured intracranial aneurysms, respectively. There was a significant increase in endovascular treatment after publication of the ISAT (trend test, p < 0.0001) The in-hospital mortality for ruptured intracranial aneurysm admissions decreased from 27% to 24% (odds ratio [OR] 0.89, 95% CI 0.83–0.96, p = 0.003) after the publication of the ISAT. The cost of hospitalization after adjusting for procedures practices was not significantly higher after the publication of the ISAT ($21,437 vs $22,817, p < 0.89), but cost of hospitalization was higher in the post-ISAT period for patients undergoing endovascular procedure. Conclusions The results of the ISAT have been associated with a prominent change in practice patterns related to the treatment of ruptured aneurysms. The cost of hospitalization has increased and the mortality has decreased, presumably due to a larger proportion of patients receiving any treatment and endovascular treatment.
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Masterson, Sarah A., Megan M. Kennelly, Rhonda R. Janke i Cary L. Rivard. "Scion Shoot Removal and Rootstock Cultivar Affect Vigor and Early Yield of Grafted Tomatoes Grown in High Tunnels in the Central United States". HortTechnology 26, nr 4 (sierpień 2016): 399–408. http://dx.doi.org/10.21273/horttech.26.4.399.
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Grafting with interspecific hybrid rootstock is effective for tomato (Solanum lycopersicum) growers looking to reduce soilborne disease in the southeastern United States. However, production with grafted tomato has not been tested in the central United States, where soilborne disease pressure is low. Small-acreage growers would like to produce grafted plants themselves, but many have difficulty with propagation due to water stress in the scion postgrafting and/or high temperatures. Removing the upper portion of the scion to reduce leaf area during the grafting procedure [shoot removal (SR)] could help to reduce water stress postgrafting, but there are no data available that indicate what effect this practice has on tomato yield. Five high tunnel trials and one open-field trial were conducted in 2011 and 2012 to investigate potential yield effects related to the use of two rootstocks and SR during the grafting procedure. The implementation of grafting with rootstocks significantly increased fruit yield in five of the six trials (P < 0.05). The average yield increases by ‘Maxifort’ and ‘Trooper Lite’ tomato rootstocks were 53% and 51%, respectively, across all trials. SR during the grafting process may penalize tomato yield and our results suggest that rootstock vigor plays a role. Plants grafted with ‘Maxifort’ across all of the trials consistently increased shoot biomass in four of five of the high tunnel trials compared with nongrafted plants (P < 0.05), whereas plants grafted with ‘Trooper Lite’ rootstock increased shoot biomass in one trial. Similarly, the SR method penalized the total fruit yield of plants grafted with ‘Trooper Lite’ more often than those that were grafted with ‘Maxifort’. Our results suggest that plant growth and ultimately tomato fruit yield is affected negatively by using the SR grafting technique, particularly when less vigorous rootstock is used.
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Mhatre, Shivani K., Ching-Yi Chuo, Alicia K. Morgans, Osama E. Rahma, Russell Kent Pachynski, Jorge Martinalbo, Nicole N. Davarpanah i Jessica Davies. "Treatment (tx) characteristics of patients (pts) with locally advanced or metastatic urothelial cancer (mUC) receiving atezolizumab (atezo) monotherapy in United States clinical practice." Journal of Clinical Oncology 37, nr 7_suppl (1.03.2019): 381. http://dx.doi.org/10.1200/jco.2019.37.7_suppl.381.
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381 Background: Atezo (anti–PD-L1) was the first immune checkpoint inhibitor approved for mUC. Here, we describe pt characteristics, time on tx (TOT) and distribution of tx cycles for pts receiving atezo in clinical practice, to complement data from clinical trial setting. Methods: Pts diagnosed with mUC who initiated atezo monotherapy in the first-line (1L) or second-line and beyond (2L+; prior platinum tx) settings on or before Jun 30, 2017, were identified from the US-based Flatiron Health electronic health record–derived database. Tx data were analyzed through Mar 31, 2018. TOT was defined as time from first to last atezo administration, plus 1 cycle length. Median TOT was calculated by tx line using the Kaplan-Meier method. Tx cycles were calculated by the number of atezo doses received during TOT. Corresponding results from global atezo clinical trials are presented. Results: Real-world data (RWD) from 312 pts (n = 102, 1L; n = 210, 2L+) met the study selection criteria (Table). Median TOT was 3 and 3.5 months in the 1L and 2L+ settings, respectively, with 95% CIs overlapping with the trial TOT data. A median of 4 cycles (IQR, 2-7, 1L; 2-9, 2L+) was administered in both settings. Conclusions: This is the first study of RW atezo use in mUC. The TOT with atezo observed in a US RW setting and the clinical setting (IMvigor210/IMvigor211) was similar. [Table: see text]
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Birhiray, Ruemu Ejedafeta, i Maya Nicole Birhiray. "Clinical research in the community". Hematology 2023, nr 1 (8.12.2023): 324–31. http://dx.doi.org/10.1182/hematology.2023000432.
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Abstract Most patients with high-risk hematologic malignancies are treated in community oncology practices near their residence. This is partly due to patients' ardent desire to be closer to home and trust in local caregivers. Treatments are increasingly complex, even as initial therapy, and more so upon relapse. Improved outcomes in the past decade are largely available through clinical trials primarily offered through academic medical centers. Limited availability of clinical trials at community oncology practices is a major contributor to outcome disparities among minorities, rural, and elderly patients, all of whom are underrepresented in clinical trials. Between 2003 and 2023, the National Cancer Institute (NCI) established programs to address these challenges: the Community Clinical Oncology Program, Minority- Based Community Clinical Oncology Program, NCI Community Cancer Centers Program, and NCI Community Oncology Research Program. However, disparities have persisted, particularly for pharmaceutical-directed clinical research. Lack of representation in clinical research results in data absenteeism, data chauvinism and hallucination, and a delay in treatment availability for high-risk hematologic malignancies in community practice. To address this, the US Congress enacted the Food and Drug Administration Omnibus Act in 2022 to help establish diversity plans that would broaden clinical trial patient enrollment in the United States. We recommend using these initiatives in community oncology practices, including the adoption of the DRIVE strategy in collaboration with pharmaceutical companies, as well as using the NCI-established programs to promote clinical trial availability for patients with high-risk malignancies treated in community oncology practices.
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Osganian, Stavroula K., Guy S. Parcel i Elaine J. Stone. "Institutionalization of a School Health Promotion Program: Background and Rationale of the Catch-on Study". Health Education & Behavior 30, nr 4 (sierpień 2003): 410–17. http://dx.doi.org/10.1177/1090198103252766.
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Research is lacking on how to make effective programs available on a large scale and how to maintain levels of implementation. CATCH: A Study of Institutionalization (CATCH-ON) was designed to help us understand the conditions under which such programs are institutionalized after the trial has ended. The Child and Adolescent Trial for Cardiovascular Health (CATCH) was the largest field trial of school-based health promotion in the United States conducted in 96 schools in four geographic areas of the United States: California, Louisiana, Minnesota, and Texas. The intervention was multicomponent, targeting school policy and practices in nutrition, physical activity, health education, and smoking. This report provides background on the CATCH study design, the conceptual framework for research on institutionalization of the CATCH program, and an overview of the seven original reports that present results from the CATCH-ON study in this theme issue.
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Combest, Austin James, Dirk J. Reitsma, Angelena Moseley, Savanna D. Steele i Marie-Edith Anne Bonneterre. "Adult participation in oncology clinical trials by indication, race, and age." Journal of Clinical Oncology 31, nr 15_suppl (20.05.2013): e17586-e17586. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.e17586.
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e17586 Background: According to the National Cancer Institute (NCI), approximately 3 percent of adult cancer patients participate in clinical trials despite the NCCN guidelines frequently recommending clinical trials as standard of care in many circumstances (Mooney, 2010). In a large analysis of NCI Cancer Therapy Evaluation Program (CTEP) trials, 40 percent of trials failed to achieve minimum enrollment, including 3 of 5 phase III trials (Cheng, 2010). Additionally, concerns about unequal access to clinical trials led Congress to enact the National Institutes of Health (NIH) Revitalization Act 20 years ago (June 10, 1993). Using data from Ipsos’ Tandem Oncology Monitor, a robust, nationwide system that collects actual prescriptions and clinical trial participation by indication from 500 oncologists and hematologists from the United States, we evaluated current participation and ethnic diversity in clinical trials. Methods: We assessed adult clinical trial participation from October 2011 to September 2012. Age, ethnicity and practice type were also collected to identify descriptive trends. Results: With regards to indication, clinical trial participation ranged from 1 percent (prostate, renal cell and head and neck) to 12 percent (thyroid) averaging between 2 and 3 percent. We observed a decline in first-line metastatic melanoma participation between pre- and post- vemurafenib/ipilimumab approval (9%-pre versus 2%-post). Patient diversity results are included in the Table. Conclusions: Despite efforts to increase oncology clinical trial participation, we have observed overall low clinical trial participation. Additionally, we observed better trial participation in the youngest age groups and minor differences between ethnic categories. Continued focus on increasing trial participation and patient diversity is still needed. [Table: see text]
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Friedland, Martin L., i Kent Roach. "Borderline Justice: Choosing Juries in the Two Niagaras". Israel Law Review 31, nr 1-3 (1997): 120–58. http://dx.doi.org/10.1017/s0021223700015260.
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This paper examines the use of juries in criminal cases in Canada and the United States. It is part of a larger study of the administration of criminal justice in Niagara County, Ontario and Niagara County, New York. The basic question examined is why persons accused of serious crimes in the United States usually select a jury, whereas persons in similar circumstances in Canada normally select trial by a judge alone. An investigation of this question will enable us to see some significant differences between the administration of criminal justice in the United States and Canada. It will also show how changes in specific procedural rules may affect other practices. There is a complex interplay between procedural rules. The paper concludes by showing that the widespread use of juries in the United States is consistent with the more populist grass-roots approach in American society which tends to distrust government, compared with the traditional respect for authority, including the authority of judges, in Canada.
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Carpenter, Anna E., Alyx Mark i Colleen F. Shanahan. "Trial and Error: Lawyers and Nonlawyer Advocates". Law & Social Inquiry 42, nr 04 (2017): 1023–57. http://dx.doi.org/10.1111/lsi.12252.
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Nonlawyer advocates are one proposed solution to the access to justice crisis. Theory and research suggest that nonlawyers might be effective, yet scholars know very little, empirically, about nonlawyer practice in the United States. Using data from more than 5,000 unemployment insurance appeal hearings and interviews with lawyers and nonlawyers who represent employers in these hearings, this article explores how both types of representatives develop expertise and what this means for effectiveness. We find judges play a critical role in shaping nonlawyer legal expertise and nonlawyers develop expertise almost exclusively through “trial and error.” We find evidence that while experienced nonlawyers can help parties through their expertise with common court procedures and basic substantive legal concepts, they are not equipped to challenge judges on contested issues of substantive or procedural law in individual cases, advance novel legal claims, or advocate for law reform on a broader scale. These findings have implications for future access to justice research and interventions.
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Wang, Xiaoliang, Blythe J. Adamson, Katherine Tan, Shrujal Baxi, Andrew Briggs i Scott D. Ramsay. "OP520 Evaluating Long-Term Survival From Clinical Trials: Does Real-World Evidence Change the Paradigm?" International Journal of Technology Assessment in Health Care 36, S1 (grudzień 2020): 12. http://dx.doi.org/10.1017/s026646232000118x.
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IntroductionBoth patient composition and medical care received in clinical trials may not be representative of clinical practice, yet health technology assessments (HTAs) commonly use extrapolation results from trials to estimate incremental benefit. Due to data limitations, external validation of trial extrapolations are uncommon. With the goal of better estimating the benefit of new therapies in practice, we compared long-term survival estimated from real-world patients who received therapy similar to the comparator arm of the OAK trial, a phase III study of patients with advanced non-small cell lung cancer (aNSCLC) who progressed following initial chemotherapy, to standard estimation approaches.MethodsWe estimated long-term survival from: (i) direct extrapolation of trial survival curves; and (ii) aNSCLC patients from the United States Flatiron Health Electronic Health Record ()-derived de-identified database diagnosed between January 2011 and August 2019 who received docetaxel monotherapy after platinum-doublet and had adequate organ function as well as functional status. Patients with unknown organ function and functional status were also included. Standard parametric extrapolations were applied and selected based on visual inspection and goodness-of-fit tests for each cohort.ResultsUsing a log-logistic model to extrapolate the trial comparator arm (N = 425), estimated lifetime mean overall survival was 19.2 months (95% confidence interval [95% CI]: 16.5–22.6), and 14.4 months (95% CI: 12.4–17.0) for the real-world cohort (N = 415). Estimated 5-year overall survival rates were 5.4 percent (95% CI: 3.9–7.3) for the trial patients, compared to 3.7 percent (95% CI: 2.6–5.0) among real-world cohort patients.ConclusionsOur results suggest that directly extrapolating observed survival for trial patients may overestimate the long-term survival compared to the experience of patients treated in routine practice. Our findings have implications for those wishing to estimate the incremental benefit for novel versus established treatments. We plan to compare our results to a generic patient cohort from national cancer registry. Further EHR-based studies utilizing real world data are needed to confirm our findings and to extend beyond this use case for other cancer types and anti-neoplastic therapies.
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Wolfe, Rory, Anne M. Murray, Robyn L. Woods, Brenda Kirpach, David Gilbertson, Raj C. Shah, Mark R. Nelson i in. "The aspirin in reducing events in the elderly trial: Statistical analysis plan". International Journal of Stroke 13, nr 3 (7.11.2017): 335–38. http://dx.doi.org/10.1177/1747493017741383.
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Rationale Aspirin has positive and negative effects on a number of age-related chronic conditions and there is uncertainty regarding its role in primary prevention in people aged 70 years and over. Aims To assess whether daily active treatment of 100 mg enteric-coated aspirin will extend the duration of disability-free life in healthy older participants. Design A double-blind, randomized, placebo-controlled primary prevention trial undertaken in Australia and the United States with careful adjudication of endpoints including stroke. Study outcome In Australia 16,703 individuals were recruited through general practices across five states and territories, and in the United States, 2411 participants were recruited through 34 clinical sites across the country. Follow-up of participants will finish at the end of 2017 with average follow-up exceeding 4.25 years per person. Discussion The statistical analysis plan for ASPREE, finalized after closure of recruitment but before the end of patient follow-up, outlines the primary analyses and a range of subgroup and sensitivity analyses. (International Standard Randomized Controlled Trial Number Register ISRCTN83772183 and clinicaltrials.gov Number NCT01038583)
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Altomare, Ivy, Yichen Lu, Sumanta Kumar Pal, Leigh Boehmer, Latha Shivakumar, Lyndsey Griffin, Kimberly Demirhan, Molly Kisiel i Randall A. Oyer. "Characterization of cancer clinical trials in the community setting." Journal of Clinical Oncology 42, nr 16_suppl (1.06.2024): e13506-e13506. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.e13506.
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e13506 Background: Extending clinical trials to community oncology sites is an imperative to meet accrual goals, ensure generalizable results, and facilitate optimal and equitable clinical care. The types of trials attractive to and successful in the community, however, are likely different from those run primarily at academic centers. We analyzed the characteristics of clinical trials open at a network of community oncology practices across the United States in the last 2 years, in order to inform both sponsors and sites about the studies most well-suited for a community setting. Methods: We analyzed characteristics from every clinical trial entered in OncoTrials, a clinical trial screening and tracking tool utilized exclusively by US community oncology practices, between 9/1/2021 through 10/09/2023 via knowledge of the trial NCT number and data available through API from clinicaltrials.gov. Descriptive statistics, including median and range for continuous variables and percentages for categorical variables are reported. Results: 1,310 clinical trials were open across 64 community oncology practices. Sponsors were classified as 80% industry (n=1,054), 15% NIH (n=195), 1% network (n=13) and 5% other (n=48). 93% of studies were interventional, 5% observational, 1% registry and 1% expanded access. Types of interventional studies (n=1,215) and the number of sites that ran them are shown (Table). The median target enrollment across all studies was 235 patients. Individual trials were open at a median of 2 community practices in our cohort (range 1-22 practices); 521 clinical trials (40%) were open at only one practice and 34 trials (2.6%) were open at more than 10 practices. The mean number of unique trials open at a practice during our 2 year observation period was 54 (median 35, range 1-264). Among these trials, the most commonly associated tumor types were lung (15%), pan-solid tumors (14%), breast (11%), lymphoma (6%), colorectal (6%), prostate (5%), gynecologic (4%), bladder (4%), head and neck (4%) and melanoma (4%). Conclusions: Community oncology practices supported a robust portfolio of clinical trials, most commonly focused on treatment of solid tumors. The vast majority were interventional (phase 2-3) and industry-sponsored. Half of sites ran Phase I trials, and Phase IV trials were uncommon but had broad participation across sites. Notably, a large proportion of studies were only open at one single site in a cohort of 64 community oncology practices. This highlights the opportunity for sponsors to leverage networks, consortia, and further research to ensure that appropriate studies are accessible among a broader range of community research sites. [Table: see text]
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Herson, Jay, i John Glasby. "Comparison of clinical trials regulatory requirements and practice between European community and United States". Controlled Clinical Trials 12, nr 5 (październik 1991): 658. http://dx.doi.org/10.1016/0197-2456(91)90176-m.
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Westcott, Lauren Zammerilla, Ronald C. Jones i James W. Fleshman. "Development of the Breast Surgical Oncology Fellowship in the United States". Breast Journal 2022 (19.05.2022): 1–9. http://dx.doi.org/10.1155/2022/3342910.
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The surgical treatment of breast cancer has rapidly evolved over the past 50 years, progressing from Halsted’s radical mastectomy to a public campaign of surgical options, aesthetic reconstruction, and patient empowerment. Sparked by the research of Dr. Bernard Fisher and the first National Surgical Adjuvant Breast and Bowel Project trial in 1971, the field of breast surgery underwent significant growth over the next several decades, enabling general surgeons to limit their practices to the breast. High surgical volumes eventually led to the development of the first formal breast surgical oncology fellowship in a large community-based hospital at Baylor University Medical Center in 1982. The establishment of the American Society of Breast Surgeons, as well as several landmark clinical trials and public campaign efforts, further contributed to the advancement of breast surgery. In 2003, the Society of Surgical Oncology (SSO), in partnership with the American Society of Breast Surgeons and the American Society of Breast Disease, approved its first fellowship training program in breast surgical oncology. Since that time, the number of American fellowship programs has increased to approximately 60 programs, focusing not only on training in breast surgery, but also in medical oncology, radiation oncology, pathology, breast imaging, and plastic and reconstructive surgery. This article focuses on the happenings in the United States that led to the transition of breast surgery from a subset of general surgery to its own specialized field.
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Rodwin, Marc A. "Reforming Pharmaceutical Industry-Physician Financial Relationships: Lessons from the United States, France, and Japan". Journal of Law, Medicine & Ethics 39, nr 4 (2011): 662–70. http://dx.doi.org/10.1111/j.1748-720x.2011.00633.x.
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Post-industrial societies confront common problems in pharmaceutical industry-physician relations. In order to promote sales, drug firms create financial relationships that influence physicians' prescriptions and sometimes even reward physicians for prescribing drugs. Three main types exist: (1) kickbacks, (2) gifts, and (3) financial support for professional activities. The prevalence of these practices has evolved over time in response to changes in professional codes, law, and markets. There are certainly differences among these types of ties, but all of them can compromise physicians' independent judgment and rational prescribing.Drug firms have paid kickbacks for prescribing drugs, purchasing drugs, switching brands prescribed, adding a drug to a hospital formulary, enrolling patients in post-marketing clinical trials, and writing practice guidelines that encourage the use of certain drugs.
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Villalona-Calero, Miguel A., Jyoti Malhotra, Vincent Chung, Yan Xing, Stacy W. Gray, Heather Hampel, Stephen Gruber i Kevin McDonnell. "Integrating Early-Stage Drug Development with Clinical Networks; Challenges and Opportunities: The City of Hope Developing Experience". Journal of Clinical Medicine 12, nr 12 (15.06.2023): 4061. http://dx.doi.org/10.3390/jcm12124061.
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Recent data suggest that patients with advanced cancer who participate in biomarker/genomically informed early-stage clinical trials experience clinical benefit. While most early-stage clinical trials are conducted in major academic centers, the majority of cancer patients in the United States are treated in community practices. Here, we describe ongoing efforts at the City of Hope Cancer Center to integrate our network community oncology clinical practices into our academic, centralized biomarker/genomic-driven, early-stage clinical trial program to build an understanding of the approaches that provide the benefits of early-stage clinical trial participation to community patients. Our efforts include three key initiatives: the development of a virtual “Refractory Disease” phase 1 trial matching televideo clinic, the construction of infrastructure to support the expansion of phase 1 clinical trials to a distant regional clinical satellite hub, and the implementation of an enterprise-wide precision medicine, germline, and somatic testing program. Our work at City of Hope may serve as an example to facilitate similar efforts at other institutions.
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Madsen, Cathaleen, Megan Vaughan i Tracey Pérez Koehlmoos. "Use of Integrative Medicine in the United States Military Health System". Evidence-Based Complementary and Alternative Medicine 2017 (2017): 1–11. http://dx.doi.org/10.1155/2017/9529257.
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Integrative medicine (IM) is a model of care which uses both conventional and nonconventional therapies in a “whole person” approach to achieve optimum mental, physical, emotional, spiritual, and environmental health, and is increasingly popular among patients and providers seeking to relieve chronic or multifactorial conditions. The US Department of Defense (DoD) shows particular interest in and usage of IM for managing chronic conditions including the signature “polytrauma triad” of chronic pain, traumatic brain injury (TBI), and posttraumatic stress disorder (PTSD) among its beneficiaries in the Military Health System (MHS). These modalities range from conventional nondrug, nonsurgical options such as cognitive-behavioral therapy to nonconventional options such as acupuncture, chiropractic, and mind-body techniques. These are of particular interest for their potential to relieve symptoms without relying on opiates, which impair performance and show high potential for abuse while often failing to provide full relief. This review describes the use of IM in the MHS, including definitions of the model, common therapies and potential for use, and controversy surrounding the practice. More research is needed to build a comprehensive usage analysis, which in turn will inform sound clinical and financial practice for the MHS and its beneficiaries.
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Raheem, Farah, Pauline Kim, Meagan Grove i Patrick J. Kiel. "Precision Genomic Practice in Oncology: Pharmacist Role and Experience in an Ambulatory Care Clinic". Pharmacy 8, nr 1 (8.03.2020): 32. http://dx.doi.org/10.3390/pharmacy8010032.
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Recent advancements in molecular testing, the availability of cost-effective technology, and novel approaches to clinical trial design have facilitated the implementation of tumor genome sequencing into standard of care oncology practices. Current models of precision oncology practice include specialized clinics or consultation services based on a molecular tumor board (MTB) approach. MTBs are comprised of interprofessional teams of clinicians and scientists who evaluate tumors at the molecular level to guide patient-specific targeted therapy. The practice of precision oncology utilizing MTB-based models is an emerging approach, transforming precision genomics from a novel concept into clinical practice. This rapid shift in practice from cytotoxic therapy to targeted medicine poses challenges, yet brings exciting opportunities to clinical pharmacists practicing in hematology and oncology. Only a few precision genomics programs in the United States have a strong pharmacy presence with oncology pharmacists serving in leadership roles in research, interpreting genomic sequencing, making treatment recommendations, and facilitating off-label drug procurement. This article describes the experience of the precision medicine clinic at the Indiana University Health Simon Cancer Center, with emphasis on the role of the pharmacist in the precision oncology initiative.
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Audibert, Céline, Mark Stuntz i Daniel Glass. "Treatment Sequencing in Advanced BRAF-Mutant Melanoma Patients: Current Practice in the United States". Journal of Pharmacy Technology 34, nr 1 (4.12.2017): 17–23. http://dx.doi.org/10.1177/8755122517747089.
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Background: Treatment of advanced BRAF-mutant melanoma has changed dramatically in the past 3 years thanks to the approval of new immunotherapy and targeted therapy agents. Objectives: The goal of our survey was to investigate when immunotherapy and targeted therapy are used in the management of advanced melanoma patients and whether differences exist between the types of setting. Methods: Oncologists from academic centers, community-based centers, and private clinics were invited to participate in an online survey. Survey questions addressed the proportion of BRAF-mutant patients per treatment line, proportion of patients on targeted therapy and immunotherapy available in the United States, and reasons for prescribing each drug class. Results: A total of 101 physicians completed the survey, of which 47 worked in a private clinic, 33 in an academic center, and 21 in a community-based center. Academic center participants tended to see more severe patients ( P < .001) and had more patients in second-line treatment than participants from other setting types. In addition, academic center physicians had more patients in clinical trials ( P < .001), and they prescribed the ipilimumab and nivolumab combination more frequently. In terms of sequencing, all participants used targeted therapy for severe or rapidly progressing patients and immunotherapy for those who were less severe or slowly progressing. Conclusions: The findings illustrate the differences in treatment approach per type of setting, with patients in academic centers more likely to receive recently approved products or to be enrolled in clinical trials than those in community-based settings.
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Ferrer, Robert L., Luz-Myriam Neira, Gualberto L. De Leon Garcia, Kristin Cuellar i Jasmine Rodriguez. "Primary Care and Food Bank Collaboration to Address Food Insecurity: A Pilot Randomized Trial". Nutrition and Metabolic Insights 12 (styczeń 2019): 117863881986643. http://dx.doi.org/10.1177/1178638819866434.
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Food insecurity is common in the United States and linked to poor control of conditions influenced by diet. We conducted a pilot randomized trial to test whether a novel partnership between a primary care practice and a municipal food bank would improve control of type 2 diabetes among patients with food insecurity. Participants received food bank produce delivered twice monthly to the practice site, brief teaching from a food bank dietitian, and home-based education from a community health worker. After 6 months, glycosylated hemoglobin decreased (absolute change) by 3.1% in the intervention group vs 1.7% in the control group ( P = .012). Scores on Starting the Conversation–Diet, a brief dietary measure, improved in the intervention group by 2.47 on a 14-point scale ( P < .001). Body mass indexes (BMIs) were unchanged. In this early-stage study, onsite collaboration between primary care and a regional food bank generated clinically meaningful reductions in HbA1c and improvements in diet.
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Chokkalingam, Anand P., Jennifer Hayden, Jason D. Goldman, Hu Li, Julius Asubonteng, Essy Mozaffari, Christopher Bush i in. "Association of Remdesivir Treatment With Mortality Among Hospitalized Adults With COVID-19 in the United States". JAMA Network Open 5, nr 12 (1.12.2022): e2244505. http://dx.doi.org/10.1001/jamanetworkopen.2022.44505.
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ImportanceSARS-CoV-2, which causes COVID-19, poses considerable morbidity and mortality risks. Studies using data collected during routine clinical practice can supplement randomized clinical trials to provide needed evidence, especially during a global pandemic, and can yield markedly larger sample sizes to assess outcomes for important patient subgroups.ObjectiveTo evaluate the association of remdesivir treatment with inpatient mortality among patients with COVID-19 outside of the clinical trial setting.Design, Setting, and ParticipantsA retrospective cohort study in US hospitals using health insurance claims data linked to hospital chargemaster data from December 1, 2018, to May 3, 2021, was conducted among 24 856 adults hospitalized between May 1, 2020, and May 3, 2021, with newly diagnosed COVID-19 who received remdesivir and 24 856 propensity score–matched control patients.ExposureRemdesivir treatment.Main Outcomes and MeasuresAll-cause inpatient mortality within 28 days of the start of remdesivir treatment for the remdesivir-exposed group or the matched index date for the control group.ResultsA total of 24 856 remdesivir-exposed patients (12 596 men [50.7%]; mean [SD] age, 66.8 [15.4] years) and 24 856 propensity score–matched control patients (12 621 men [50.8%]; mean [SD] age, 66.8 [15.4] years) were included in the study. Median follow-up was 6 days (IQR, 4-11 days) in the remdesivir group and 5 days (IQR, 2-10 days) in the control group. There were 3557 mortality events (14.3%) in the remdesivir group and 3775 mortality events (15.2%) in the control group. The 28-day mortality rate was 0.5 per person-month in the remdesivir group and 0.6 per person-month in the control group. Remdesivir treatment was associated with a statistically significant 17% reduction in inpatient mortality among patients hospitalized with COVID-19 compared with propensity score–matched control patients (hazard ratio, 0.83 [95% CI, 0.79-0.87]).Conclusions and RelevanceIn this retrospective cohort study using health insurance claims and hospital chargemaster data, remdesivir treatment was associated with a significantly reduced inpatient mortality overall among patients hospitalized with COVID-19. Results of this analysis using data collected during routine clinical practice and state-of-the-art methods complement results from randomized clinical trials. Future areas of research include assessing the association of remdesivir treatment with inpatient mortality during the circulation of different variants and relative to time from symptom onset.
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Kandi, Venkataramana, Sabitha Vadakedath, Purna Singh Addanki, Vikram Godishala i Venkata Bharatkumar Pinnelli. "Clinical Trials: The Role of Regulatory Agencies, Pharmacovigilance Laws, Guidelines, Risk Management, Patenting, and Publicizing Results". Borneo Journal of Pharmacy 6, nr 1 (28.02.2023): 93–109. http://dx.doi.org/10.33084/bjop.v6i1.3263.
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The research carried out to find a better treatment, improve healthcare, and benefit the current medical practice is termed clinical research. Clinical trial includes the pharmacodynamics (mechanisms of action of a new drug), pharmacokinetics (drug metabolism inside the body), therapeutics (efficacy of the drug), and adverse effects (safety of the drug) of the novel medical products. Clinical research is a process that involves human subjects and their biological specimens. The clinical trial is a meticulously planned protocol-based study of a drug/device to discover a new/better way to prevent, diagnose, and treat a disease/illness. Considering the involvement of both healthy and diseased people in clinical trials, the regulatory authorities have a significant role in the processes involving the conduction of clinical research and carefully evaluate their potential implications on humans. Because clinical trials are usually aimed at assessing the safety and efficacy of novel pharmaceutical compounds and medical devices, pharmacovigilance laws and risk management assume increased significance while conducting clinical research/trials. In this review, we attempt to discuss the regulatory authorities' roles in different geographical regions, including the United States of America, The European Union, and India. We also focus on the importance of pharmacovigilance laws and risk management during clinical trials.
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Topaloglu, Umit, i Matvey B. Palchuk. "Using a Federated Network of Real-World Data to Optimize Clinical Trials Operations". JCO Clinical Cancer Informatics, nr 2 (grudzień 2018): 1–10. http://dx.doi.org/10.1200/cci.17.00067.
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Clinical trials, whether industry, cooperative group sponsored, or investigator initiated, have an unacceptable rate of failure as a result of the inability to recruit sufficient numbers of patients. Even those trials that are completed often require time-consuming protocol amendments to achieve accrual goals. These inefficiencies in clinical trial research result in increasing costs and prolong the time needed to bring improved treatments to cancer clinical practice. TriNetX has developed a clinical research collaboration platform—deployed by a federated network of health care organizations (HCOs), pharmaceutical firms (Pharma), and contract research organizations (CROs)—to enable data-driven clinical research study design to reduce accrual failure and protocol amendment. Currently, the network extends to 55 HCOs and covers 84 million patients, mostly within the United States, but with a growing international presence. (Many of the HCOs in United States are Clinical and Translational Science Awardees and/or National Cancer Institute–designated cancer centers.) The TriNetX business model includes Pharma and the CROs as sponsors whose subscriptions financially support the network, including the software and hardware costs of the HCOs. Furthermore, as each HCO network member has their data harmonized with the TriNetX model upon joining, data sharing among them does not require any technical processes to establish connectivity. To date, on the basis of the data on the network, HCOs have been presented approximately 757 studies by Pharma and CROs, and four data-sharing subnetworks have been formed among member HCOs.
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Holbrook, Janet T., John H. Kempen, Nancy A. Prusakowski, Michael M. Altaweel i Douglas A. Jabs. "Challenges in the design and implementation of the Multicenter Uveitis Steroid Treatment (MUST) Trial – lessons for comparative effectiveness trials". Clinical Trials 8, nr 6 (12.10.2011): 736–43. http://dx.doi.org/10.1177/1740774511423682.
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Background Randomized clinical trials (RCTs) are an important component of comparative effectiveness (CE) research because they are the optimal design for head-to-head comparisons of different treatment options. Purpose To describe decisions made in the design of the Multicenter Uveitis Steroid Treatment (MUST) Trial to ensure that the results would be widely generalizable. Methods Review of design and implementation decisions and their rationale for the trial. Results The MUST Trial is a multicenter randomized controlled CE trial evaluating a novel local therapy (intraocular fluocinolone acetonide implant) versus the systemic therapy standard of care for noninfectious uveitis. Decisions made in protocol design in order to broaden enrollment included allowing patients with very poor vision and media opacity to enroll and including clinical sites outside the United States. The treatment protocol was designed to follow standard care. The primary outcome, visual acuity, is important to patients and can be evaluated in all eyes with uveitis. Other outcomes include patient-reported visual function, quality of life, and disease and treatment related complications. Limitations The trial population is too small for subgroup analyses that are of interest and the trial is being conducted at tertiary medical centers. Conclusion CE trials require greater emphasis on generalizability than many RCTs but otherwise face similar challenges for design choices as any RCT. The increase in heterogeneity in patients and treatment required to ensure generalizability can be balanced with a rigorous approach to implementation, outcome assessment, and statistical design. This approach requires significant resources that may limit implementation in many RCTs, especially in clinical practice settings.
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Liu, Xiaonan. "China's Practice and Response Strategies for ASI of Standard-essential Patent Disputes". Journal of Education, Humanities and Social Sciences 11 (20.04.2023): 64–74. http://dx.doi.org/10.54097/ehss.v11i.7504.
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The Anti-suit injunction (ASI) system originated from the common law system. Its function has developed from the initial solution of domestic parallel litigation to the present widely used in coordinating the handling of international parallel litigation jurisdictional conflicts. In recent years, international parallel litigation is frequent in the Standard-essential Patents (SEPs), and the ASI has become an important institutional tool for resolving jurisdictional disputes over SPEs. In particular, the Chinese judiciary has started the practice of "ASI" in SEP disputes by way of behavior preservation, which has aroused widespread concern of the international community. AS Chinese law has not established an ASI system, the current judicial practice mainly refers to the trial experience in the United Kingdom and the United States, and relies on China's behavioral preservation system to make decisions. However, there are many shortcomings in this ruling itself, for example, Chinese judicial organs have paid attention to the lack of sufficient basis for the time sequence of parallel litigations, their arguments in respect of the public interest and international comity are not sufficient, and the ASI is excessively broad in terms of remedies and territorial coverage. Therefore, it is not only necessary but also urgent to establish a perfect legal system of ASI for China's legislation and judicial practice.
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Webster, MD, Lynn R., Ronald W. Chapman II, JD, LLM i Stephen J. Ziegler, PhD, JD. "Drug trafficking, good faith, and legal standards to convict: How the United States Supreme Court is about to affect every prescriber in America". Journal of Opioid Management 18, nr 3 (5.05.2022): 203–4. http://dx.doi.org/10.5055/jom.2022.0711.
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Dr. Xiulu Ruan was a pain specialist in Alabama and, following his conviction in 2017, was sentenced to serve over 20 years in federal prison for violating several provisions of the federal Controlled Substances Act (CSA) relating to his prescribing practices. Dr. Ruan appealed his conviction and, in March of this year, argued before the US Supreme Court that he had been wrongfully convicted because the trial court had denied his ability to assert a good-faith defense concerning the prescriptions he issued.1 The last time the Supreme Court interpreted the CSA and its application to criminal cases involving prescribers was almost 50 years ago. The central question now before the Court is whether the government must merely prove that the prescription was issued outside of an acceptable standard of practice (limiting the focus to the prescription itself), or whether the prescriber knew that the prescription was unlawful at the time it was written (focusing on the prescriber’s intent and whether the prescriber believed in good faith that the prescription was within the standard of care).2 While we argue here that it should be the latter, the Court’s ultimate decision will establish the standard the government can use to prosecute prescribers and will affect the practice of medicine for years to come.
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Helm, Rebecca K. "Conviction by Consent? Vulnerability, Autonomy and Conviction by Guilty Plea". Journal of Criminal Law 83, nr 2 (kwiecień 2019): 161–72. http://dx.doi.org/10.1177/0022018318822223.
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A criminal conviction resulting from a guilty plea rather than a full trial is typically justified on the basis that the defendant had the ability to go to trial but instead chose to admit guilt in exchange for a small sentence reduction. In other words, the conviction, and associated waiver of rights, occurred by consent. In this article, I challenge that notion by drawing on psycho-legal research on vulnerability and consent and research on guilty pleas in the USA. I suggest that while plea procedure in England and Wales appears less coercive than the practice of ‘plea bargaining’ in the United States, aspects of the system are highly problematic and are likely to be leading to non-consensual guilty pleas, through which innocent defendants are pleading guilty.
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Binder, Christina, Prithvi Mruthyunjaya, Amy C. Schefler, Michael I. Seider, Richard Crilly, Arthur Hung, Sheridan Meltsner i in. "Practice Patterns for the Treatment of Uveal Melanoma with Iodine-125 Plaque Brachytherapy: Ocular Oncology Study Consortium Report 5". Ocular Oncology and Pathology 6, nr 3 (11.12.2019): 210–18. http://dx.doi.org/10.1159/000504312.
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Background: Treatment planning for I-125 plaque therapy for uveal melanoma has advanced significantly since the Collaborative Ocular Melanoma Study trial, with more widely available image-guided planning and improved dosimetry. Objective: We evaluated real-world practice patterns for I-125 plaque brachytherapy in the United States by studying practice patterns at centers that comprise the Ocular Oncology Study Consortium (OOSC). Methods: The OOSC database and responses to a treatment practice survey were evaluated. The database contains treatment information from 9 institutions. Patients included in the database were treated between 2010 and 2014. The survey was conducted in 2018 and current treatment planning methods and prescriptions were queried. Results: Examination of the OOSC database revealed that average doses to critical structures were highly consistent, with the exception of one institution. Survey responses indicated that most centers followed published guidelines regarding dose and prescription point. Dose rate ranged from 51 to 118 cGy/h. As of 2018, most institutions use pre-loaded plaques and fundus photographs and/or computed tomography or magnetic resonance imaging in planning. Conclusions: While there were differences in dosimetric practices, overall agreement in plaque brachytherapy practices was high among OOSC institutions. Clinical margins and planning systems were similar among institutions, while prescription dose, dose rates, and dosimetry varied.
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Peters, Saskia M. A. B., Albert J. Jovell, Anna García-Altes i Mateu Serra-Prat. "SCREENING AND CLINICAL MANAGEMENT OF PROSTATE CANCER". International Journal of Technology Assessment in Health Care 17, nr 2 (kwiecień 2001): 215–21. http://dx.doi.org/10.1017/s0266462300105070.
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Objectives: The objectives of the study were to identify the current standards of clinical practice regarding prostate cancer screening in western Europe, Canada, and the United States, and to highlight major characteristics of current prostate cancer screening programs or patterns of practice.Methods: We performed a semi-structured interview by means of a self-administered questionnaire sent by fax to 26 institutes pertaining to the International Network of Agencies for Health Technology Assessment.Results: None of the countries surveyed had a formal national screening policy. Despite that, all the countries answering the questionnaire had discretionary, public-financed screening practices. Moreover, some scientific and professional organizations recommended population screening for prostate cancer, and few of the surveyed countries offered it as experimental practice within a randomized controlled trial. Survey results showed variation regarding screening policies, in particular test of choice, age cut-off points, and treatment prescribed for positive test results.Conclusions: Despite the lack of conclusive evidence on the benefits of prostate cancer screening, the availability of simple and easy-to-administer tests has lead to an enormous variation on screening policies around the world. Practice variations also affect prostate cancer therapy.