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Journal articles on the topic 'Multicenter clinical trial'

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Published: 7 July 2024

Last updated: 7 July 2024

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1

Justice, Jamie N., George A. Kuchel, Nir Barzilai, and Stephen Kritchevsky. "BIOMARKER STRATEGIES FOR GEROSCIENCE-GUIDED CLINICAL TRIALS." Innovation in Aging 3, Supplement_1 (November 2019): S745—S746. http://dx.doi.org/10.1093/geroni/igz038.2731.

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Abstract Significant progress in the biology of aging and animal models supports the geroscience hypothesis: by targeting biological aging the onset of age-related diseases can be delayed. Geroscience investigators will test this hypothesis in a multicenter clinical trial, to determine if interventions on biological aging processes can prevent accumulation of multiple age-related diseases and aging phenotypes in older adults. Prodigious activity is underway to develop markers of biological aging, but currently there is no aging biomarker consensus to support geroscience-guided clinical trial outcomes. We convened an expert committee to establish a framework for selection of blood-based biomarkers, emphasizing: feasibility/reliability; aging relevance; ability to predict clinical trial outcomes; and responsiveness to intervention. We applied this framework and identified a short-list of blood-based biomarkers with potential use in multicenter trials on aging. We review progress on efforts to test these candidate biomarkers of aging and development of biomarkers strategy for geroscience-guided clinical trials.

2

Chung, Kevin C., and Jae W. Song. "A Guide to Organizing a Multicenter Clinical Trial." Plastic and Reconstructive Surgery 126, no. 2 (August 2010): 515–23. http://dx.doi.org/10.1097/prs.0b013e3181df64fa.

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3

Chung, Kevin C., Sunitha Malay, and Melissa J. Shauver. "The Complexity of Conducting a Multicenter Clinical Trial." Plastic and Reconstructive Surgery 144, no. 6 (December 2019): 1095e—1103e. http://dx.doi.org/10.1097/prs.0000000000006271.

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Abbas, E. E., P. Dham, and D. Shaker. "A multicenter clinical trial in the Arab world." Transplantation Proceedings 36, no. 6 (July 2004): 1801–4. http://dx.doi.org/10.1016/j.transproceed.2004.07.037.

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5

Craig, M. T., N. S. Abramson, P. Safar, and H. Herzog. "Deferred consent in a multicenter prehospital clinical trial." Annals of Emergency Medicine 23, no. 3 (March 1994): 619–20. http://dx.doi.org/10.1016/s0196-0644(94)80337-4.

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6

Kim, Paul, Paul E. Beaulé, Yves LaFlamme, and Michael Dunbar. "Prospective Multicenter Clinical Trial of Hip Resurfacing Arthroplasty." Journal of Arthroplasty 23, no. 2 (February 2008): 318. http://dx.doi.org/10.1016/j.arth.2008.01.235.

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7

Cauch, Karen. "Early patient accrual for a multicenter clinical trial." Controlled Clinical Trials 12, no. 5 (October 1991): 717. http://dx.doi.org/10.1016/0197-2456(91)90330-o.

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HODISH, ISRAEL, RICHARD M. BERGENSTAL, MARY L. JOHNSON, REBECCA A. PASSI, ANUJ BHARGAVA, NATALIE YOUNG, DAVIDA F. KRUGER, ANGELA HAILEY, EMILY UNGER, and ERAN BASHAN. "Digitally Enhanced Insulin Therapy—A Multicenter Clinical Trial." Diabetes 67, Supplement 1 (May 2018): 353—OR. http://dx.doi.org/10.2337/db18-353-or.

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9

Howard, Virginia J. "Recruitment of clinicaal centers in an investigator-initiated multicenter clinical trial." Controlled Clinical Trials 13, no. 5 (October 1992): 394. http://dx.doi.org/10.1016/0197-2456(92)90084-d.

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10

KITABATAKE, AKIRA. "Ideal way of multicenter clinical trial - science and ethics. Clinical trial in circulatory diseases." Nihon Naika Gakkai Zasshi 86, no. 9 (1997): 1680–83. http://dx.doi.org/10.2169/naika.86.1680.

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HIRAI, SHUNSAKU. "Ideal way of multicenter clinical trial - science and ethics. Clinical trial in neurologic diseases." Nihon Naika Gakkai Zasshi 86, no. 9 (1997): 1684–88. http://dx.doi.org/10.2169/naika.86.1684.

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SAIJO, NAGAHIRO. "Ideal way of multicenter clinical trial - science and ethics. Clinical trial of cancer therapy." Nihon Naika Gakkai Zasshi 86, no. 9 (1997): 1689–92. http://dx.doi.org/10.2169/naika.86.1689.

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13

Nishio, Teiji, Mitsuhiro Nakamura, Hiroyuki Okamoto, Satoshi Kito, Toshiyuki Minemura, Shuichi Ozawa, Yu Kumazaki, et al. "An overview of the medical-physics-related verification system for radiotherapy multicenter clinical trials by the Medical Physics Working Group in the Japan Clinical Oncology Group–Radiation Therapy Study Group." Journal of Radiation Research 61, no. 6 (September 29, 2020): 999–1008. http://dx.doi.org/10.1093/jrr/rraa089.

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Abstract The Japan Clinical Oncology Group–Radiation Therapy Study Group (JCOG-RTSG) has initiated several multicenter clinical trials for high-precision radiotherapy, which are presently ongoing. When conducting multi-center clinical trials, a large difference in physical quantities, such as the absolute doses to the target and the organ at risk, as well as the irradiation localization accuracy, affects the treatment outcome. Therefore, the differences in the various physical quantities used in different institutions must be within an acceptable range for conducting multicenter clinical trials, and this must be verified with medical physics consideration. In 2011, Japan’s first Medical Physics Working Group (MPWG) in the JCOG-RTSG was established to perform this medical-physics-related verification for multicenter clinical trials. We have developed an auditing method to verify the accuracy of the absolute dose and the irradiation localization. Subsequently, we credentialed the participating institutions in the JCOG multicenter clinical trials that were using stereotactic body radiotherapy (SBRT) for lungs, intensity-modulated radiotherapy (IMRT) and volumetric-modulated arc therapy (VMAT) for several disease sites, and proton beam therapy (PT) for the liver. From the verification results, accuracies of the absolute dose and the irradiation localization among the participating institutions of the multicenter clinical trial were assured, and the JCOG clinical trials could be initiated.

14

Milovanov, Svyatoslav S. "Parameters and indicators selection of clinical centers in predicting the patients enrollment for clinical trials." RUDN Journal of Medicine 27, no. 4 (December 15, 2023): 496–514. http://dx.doi.org/10.22363/2313-0245-2023-27-4-496-514.

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Relevance. Recruitment of patients and its compliance with the clinical trial protocol is one of the main goals of conducting a feasibility study before starting any clinical trial. Study feasibility is a must before starting any international multicentre clinical trial, and one of the main goals of feasibility is to find clinical centers with a suitable pool of patients for their subsequent selection and prediction of patient recruitment according to protocol requirements. Well-conducted fitness is clinical centers that recruit eligible patients in compliance with the protocol framework and the recruitment numbers proposed by the centers. After conducting fability, the patient recruitment prediction coincides with the protocol patient recruitment prediction. However, more than half of international multicenter clinical trials fail due to unsuccessful patient recruitment. A widely used method in the study of feasibility is a questionnaire and the reasons for subsequent failures in a clinical trial can be both an underestimation of the information provided in the questionnaires, and the lack of appropriate parameters and indicators, and, as a result, the selection of inappropriate clinical centers. Exposure to the subjectivity of opinion in the selection of sites also leads to poor selection of sites and, therefore, relevance in an objective and independent assessment remains. The aim of the study was to analyze the set of patients in selected clinical trials, identify set-related parameters and measures, and find a statistically significant relationship with a successful set of analyzed parameters and measures. Materials and Methods: A retrospective analysis of 4 international multicenter clinical trials of II-III phases was carried out for the recruitment of patients. The selection criterion is a successful recruitment of patients. Statistical analysis: descriptive statistics, multivariate analysis, correlation analysis. Results and Discussion. Parameters and indicators were found that showed a strong statistical correlation with successful recruitment of patients in clinical centers. As a result of the study, conclusions were drawn about the need to expand the use of parameters and the ratio of parameters: instead of indicators of one parameter - the expected set of patients before inclusion in the mandatory assessment of sites is a calculated parameter, it is also necessary to additionally take into account the following parameters: type of site and initial response time in days. Conclusions. Using the proposed parameters and metrics will reduce the likelihood of failure in patient recruitment. These parameters will make it possible to evaluate clinical centers with a prediction of the number of patients and to select more qualitative clinical centers.

15

Rovers, Maroeska M., Huub Straatman, Gerhard A. Zielhuis, Koen Ingels, and Gert-Jan van der Wilt. "USING A BALANCING PROCEDURE IN MULTICENTER CLINICAL TRIALS." International Journal of Technology Assessment in Health Care 16, no. 1 (January 2000): 276–81. http://dx.doi.org/10.1017/s0266462300161239.

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Objective: A basic issue in randomized controlled trials (RCTs) is whether we can safely assume comparability between groups at baseline with respect to all potentially important prognostic factors. In other words, did randomization work sufficiently well? In small trials balanced allocation procedures are employed, whereas in large-scale trials simple randomization will do. The question is: When should balancing be considered?Methods: We performed a simulation study in which we varied the number of categories in the prognostic factors and the number of patients.Results: Simulation showed that, in all instances, a balancing procedure almost always led to perfect or almost perfect balance, while the imbalance with simple randomization was larger. To study the effect of balanced and random allocation on subgroup analyses in our OME trial, we compared the quotient of the width of the confidence intervals (CI). The widest CI in random allocation over the 13 hospitals was on average 13% wider than in balanced allocation.Conclusion: Investigators should always consider balanced allocation, especially in categories with a low number of patients and when subgroup analysis over many categories is requested.

16

Husband, J., C. Cassidy, C. Leinberry, M. S. Cohen, J. Jupiter, M. McQueen, and W. Seitz. "Multicenter clinical trial of Norian SRS versus conventional therapy in the treatment of distal radius fractures: Results from multicenter clinical trial." Journal of Biomechanics 31 (July 1998): 5. http://dx.doi.org/10.1016/s0021-9290(98)80010-9.

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17

Dawood, A., A. Shaaban, and M. Omar. "Outcomes of ovarian endometrioma aspiration before ultra-long agonist protocol during ICSI cycles: a multicenter randomized clinical trial." Voprosy ginekologii, akušerstva i perinatologii 22, no. 3 (2023): 45–53. http://dx.doi.org/10.20953/1726-1678-2023-3-45-53.

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Ovarian endometriomas negatively affect the outcomes of intracytoplasmic sperm injection (ICSI). Numerous procedures and medications have been used to reduce the negative impact of endometriomas on ICSI outcomes. Endometrioma aspiration is one such procedure with controversial results. Objective. To evaluate the therapeutic efficacy and reproductive outcomes of endometrioma aspiration before starting a long ICSI protocol with agonists. Patients and methods. This multicenter randomized clinical trial enrolled 84 women with small ovarian endometrioma (3–5 cm) previously diagnosed by ultrasound in five fertility centers in Egypt from July 2017 to June 2022. Participants were randomly allocated into two groups (n = 42/each). Group I underwent endometrioma aspiration prior to the ultra-long agonist protocol, and group II had only the ultra-long agonist protocol. The rate of clinical pregnancy, cycle cancellation, ovarian hyperstimulation syndrome, endometrioma recurrence, and pelvic infections were measured. Results. Endometrioma size decreased significantly after aspiration. The total dose of gonadotropins and the duration of stimulation were statistically significantly lower in group I compared to the control group (p < 0.001 for both groups). The total number of retrieved and mature oocytes as well as the number of developed embryos were statistically significantly higher in group I than in the control group (p < 0.001 for both groups). However, there were no statistically significant differences between the groups regarding embryo quality and the rates of pregnancy, miscarriage, and live births. Conclusion. Aspiration of small ovarian endometriomas before the ultra-long protocol in ICSI cycles reduced gonadotropin doses, shortened the stimulation period, and increased the number of retrieved oocytes. Nevertheless, there were no significant differences regarding embryo quality and pregnancy rates between the two groups. Key words: endometriosis, ICSI, ovulation, pregnancy

18

Shin, Youngbin, Kyung Won Kim, Amy Junghyun Lee, Yu Sub Sung, Suah Ahn, Ja Hwan Koo, Chang Gyu Choi, Yousun Ko, Ho Sung Kim, and Seong Ho Park. "A Good Practice–Compliant Clinical Trial Imaging Management System for Multicenter Clinical Trials: Development and Validation Study." JMIR Medical Informatics 7, no. 3 (August 30, 2019): e14310. http://dx.doi.org/10.2196/14310.

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Background With the rapid increase in utilization of imaging endpoints in multicenter clinical trials, the amount of data and workflow complexity have also increased. A Clinical Trial Imaging Management System (CTIMS) is required to comprehensively support imaging processes in clinical trials. The US Food and Drug Administration (FDA) issued a guidance protocol in 2018 for appropriate use of medical imaging in accordance with many regulations including the Good Clinical Practice (GCP) guidelines. Existing research on CTIMS, however, has mainly focused on functions and structures of systems rather than regulation and compliance. Objective We aimed to develop a comprehensive CTIMS to meet the current regulatory guidelines and various required functions. We also aimed to perform computerized system validation focusing on the regulatory compliance of our CTIMS. Methods Key regulatory requirements of CTIMS were extracted thorough review of many related regulations and guidelines including International Conference on Harmonization-GCP E6, FDA 21 Code of Federal Regulations parts 11 and 820, Good Automated Manufacturing Practice, and Clinical Data Interchange Standards Consortium. The system architecture was designed in accordance with these regulations by a multidisciplinary team including radiologists, engineers, clinical trial specialists, and regulatory medicine professionals. Computerized system validation of the developed CTIMS was performed internally and externally. Results Our CTIMS (AiCRO) was developed based on a two-layer design composed of the server system and the client system, which is efficient at meeting the regulatory and functional requirements. The server system manages system security, data archive, backup, and audit trail. The client system provides various functions including deidentification, image transfer, image viewer, image quality control, and electronic record. Computerized system validation was performed internally using a V-model and externally by a global quality assurance company to demonstrate that AiCRO meets all regulatory and functional requirements. Conclusions We developed a Good Practice–compliant CTIMS—AiCRO system—to manage large amounts of image data and complexity of imaging management processes in clinical trials. Our CTIMS adopts and adheres to all regulatory and functional requirements and has been thoroughly validated.

19

Vermeersch, Kristina, Bénédicte Demeyere, Karen Denaux, Katelijne De Nys, Thierry Troosters, Guy G. Brusselle, and Wim Janssens. "Challenges and threats of investigator-initiated multicenter randomized controlled trials: the BACE trial experience." International Journal of Clinical Trials 6, no. 4 (October 19, 2019): 175. http://dx.doi.org/10.18203/2349-3259.ijct20194652.

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<p class="abstract"><strong>Background:</strong> Investigator-initiated clinical research has become a complex environment. Increasing administrative tasks and costs, imposed by stringent regulatory demands, risk to reduce this creative, independent and indispensable research field. The objective of the present study was to illustrate the burden of non-scientific challenges associated with an investigator-initiated multicentre randomized controlled trial, based on the Belgian trial with azithromycin for Chronic obstructive pulmonary disease (COPD) Exacerbations requiring hospitalization (BACE) trial experience.</p><p class="abstract"><strong>Methods:</strong> The trial enrolled 301 patients with COPD, hospitalized for an acute exacerbation between 2014-2017, and assessed the potential of azithromycin, an off-patent antibiotic. Key experienced challenges were complemented with registry data from the Clinical Trial Centre of the University Hospital Leuven to outline the local clinical respiratory research field, quotations for the trial protocol obtained from 3 pharmaceutical companies to provide insight into the budget restraints and a participation survey to capture the consortium’s perspective.</p><p class="abstract"><strong>Results:</strong> 60% of the required sample size was enrolled. Key challenges included trial implementation, study drug and database management. Industry-initiated trials dominated the local research field (61%), whereas investigator-initiated prospective interventional and multicenter trials accounted for 19% and 13%, respectively. The triple quotation revealed the BACE trial to require 1.6 to 2.1-fold the amount when executed by the pharmaceutical industry. The survey identified the lack of a local study team as an important obstacle for participation, along with inadequate financial compensation and excessive administrative workload.</p><p class="abstract"><strong>Conclusions: </strong>Without an adaptation of current regulatory and funding policies to overcome non-scientific challenges, investigator-initiated clinical research is risking to further decline.</p>

20

Whellan, David J. "Method for Establishing Authorship in a Multicenter Clinical Trial." Annals of Internal Medicine 151, no. 6 (September 15, 2009): 414. http://dx.doi.org/10.7326/0003-4819-151-6-200909150-00006.

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21

Bae, Jong Hwa. "Multicenter Clinical Trial of Atorvastatin in Patients with Hypercholesterolemia." Korean Circulation Journal 31, no. 4 (2001): 434. http://dx.doi.org/10.4070/kcj.2001.31.4.434.

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22

Aitken, Leanne M., Michele M. Pelter, Beverly Carlson, Andrea P. Marshall, Rebecca Cross, Sharon McKinley, and Kathleen Dracup. "Effective Strategies for Implementing a Multicenter International Clinical Trial." Journal of Nursing Scholarship 40, no. 2 (June 2008): 101–8. http://dx.doi.org/10.1111/j.1547-5069.2008.00213.x.

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23

Quan, Hui, and Thomas Capizzi. "Adjusted Regression Trend Test for a Multicenter Clinical Trial." Biometrics 55, no. 2 (June 1999): 460–62. http://dx.doi.org/10.1111/j.0006-341x.1999.00460.x.

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24

Ginsberg, Myron D., Yuko Y. Palesch, Renee H. Martin, Michael D. Hill, Claudia S. Moy, Bonnie D. Waldman, Sharon D. Yeatts, Diego Tamariz, and Karla Ryckborst. "The Albumin in Acute Stroke (ALIAS) Multicenter Clinical Trial." Stroke 42, no. 1 (January 2011): 119–27. http://dx.doi.org/10.1161/strokeaha.110.596072.

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25

Lass, Jonathan, Judy Gordon, Alan Sugar, Richard Norden, William Reinhart, Roger Meyer, and H. Kaz Soong. "A PROSPECTIVE MULTICENTER CLINICAL TRIAL OF OPTISOL CONTAINING STREPTOMYCIN." Cornea 12, no. 1 (January 1993): 92. http://dx.doi.org/10.1097/00003226-199301000-00055.

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26

White, Kamila S., Laura B. Allen, David H. Barlow, Jack M. Gorman, M. Katherine Shear, and Scott W. Woods. "Attrition in a Multicenter Clinical Trial for Panic Disorder." Journal of Nervous and Mental Disease 198, no. 9 (September 2010): 665–71. http://dx.doi.org/10.1097/nmd.0b013e3181ef3627.

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27

Das, Anita, Elizabeth Thom, Brian Mercer, Donald McNellis, and the NICHD MFMU Network. "P68 Primary outcome verification in a multicenter clinical trial." Controlled Clinical Trials 17, no. 2 (April 1996): S133—S134. http://dx.doi.org/10.1016/0197-2456(96)84688-5.

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Chancellor, Michael, H. Barton Grossman, John Konnak, Ananias C. Diokno, Jose Gonzalez, J. Edson Pontes, Robert P. Huben, and Gary W. King. "Biocarbon ureterostomy device for urinary diversion Multicenter clinical trial." Urology 34, no. 1 (July 1989): 18–21. http://dx.doi.org/10.1016/0090-4295(89)90149-0.

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29

van Alphen, H. August M., Reinder Braakman, P. Dick Bezemer, Gijs Broere, and M. Willem Berfelo. "Chemonucleolysis versus discectomy: a randomized multicenter trial." Journal of Neurosurgery 70, no. 6 (June 1989): 869–75. http://dx.doi.org/10.3171/jns.1989.70.6.0869.

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✓ A randomized clinical trial was carried out to compare the results of open discectomy with those of chemonucleolysis in 151 patients suffering from a disc herniation at L4–5 or L5–S1. All patients fulfilled strict entry criteria; 78 patients underwent open discectomy and 73 were subjected to chemonucleolysis. An increase in radicular pain immediately after treatment was encountered in 16 patients (22%) in the chemonucleolysis group, as compared to none in the discectomy group. The efficacy of discectomy appeared to be definitely superior to that of chemonucleolysis. Within a follow-up period of 1 year, 18 patients (25%) required open discectomy following failed chemonucleolysis; two patients (3%) in the discectomy group needed a second operation. Open discectomy following previous chemonucleolysis was successful in only 44% of cases. Comparison of the final results of the two modes of treatment 12 months after the last intervention (including second treatment) did not reveal any significant differences. The duration of the preoperative symptoms, the level of disc herniation, and the leakage of contrast medium out of the disc appeared to be of no relevance to the final outcome. The complication rates in both treatment groups were low.

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DiSerio, Frank J., Arnold P. Friedman, Jeffrey Parno, and Jack M. Singer. "Proquazone for Tension Headache-A Multicenter Trial." Headache: The Journal of Head and Face Pain 25, no. 3 (May 1985): 127–33. http://dx.doi.org/10.1111/j.1526-4610.1985.hed2503127.x.

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Henderson, V. W., E. Roberts, C. Wimer, E. L. Bardolph, H. C. Chui, A. R. Damasio, P. J. Eslinger, et al. "Multicenter trial of naloxone in alzheimer's disease." Annals of Neurology 25, no. 4 (April 1989): 404–6. http://dx.doi.org/10.1002/ana.410250413.

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Cumming, Toby B., Danielle Lowe, Thomas Linden, and Julie Bernhardt. "The AVERT MoCA Data: Scoring Reliability in a Large Multicenter Trial." Assessment 27, no. 5 (June 7, 2018): 976–81. http://dx.doi.org/10.1177/1073191118771516.

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The Montreal Cognitive Assessment (MoCA) is a widely used cognitive screening tool in stroke. As scoring the visuospatial/executive MoCA items involves subjective judgement, reliability is important. Analyzing data on these items from A Very Early Rehabilitation Trial (AVERT), we compared the original scoring of assessors ( n = 102) to blind scoring by a single, independent rater. In a sample of scoresheets from 1,119 participants, we found variable interrater reliability. The match between original assessors and the independent rater was the following: trail-making 97% (κ = 0.94), cube copy 90% (κ = 0.80), clock contour 92% (κ = 0.49), clock numbers 89% (κ = 0.67), and clock hands 72% (κ = 0.46). For all items except clock contour, the independent rater was “stricter” than the original assessors. Discrepancies were typically errors in original scoring, rather than borderline differences in subjective judgement. In trials that include the MoCA, researchers should emphasize scoring rules to assessors and implement independent data checking, especially for clock hands, to maximize accuracy.

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Chavez, Julio C., Christina Bachmeier, and Mohamed A. Kharfan-Dabaja. "CAR T-cell therapy for B-cell lymphomas: clinical trial results of available products." Therapeutic Advances in Hematology 10 (January 2019): 204062071984158. http://dx.doi.org/10.1177/2040620719841581.

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Adoptive cellular immunotherapy with chimeric antigen receptor (CAR) T cell has changed the treatment landscape of B-cell non-Hodgkin’s lymphoma (NHL), especially for aggressive B-cell lymphomas. Single-center and multicenter clinical trials with anti-CD19 CAR T-cell therapy have shown great activity and long-term remissions in poor-risk diffuse large B-cell lymphoma (DLBCL) when no other effective treatment options are available. Two CAR T-cell products [axicabtagene ciloleucel (axi-cel) and tisagenlecleucel] have obtained US Food and Drug Administration approval for the treatment of refractory DLBCL after two lines of therapy. A third product, liso-cel, is currently being evaluated in clinical trials and preliminary results appear very promising. CAR T-cell-related toxicity with cytokine-release syndrome and neurotoxicity remain important potential complications of this therapy. Here, we review the s biology, structure, clinical trial results and toxicity of two commercially approved CAR T-cell products and others currently being studied in multicenter clinical trials in B-cell NHLs.

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Wallace, Amy E., Guy Young, Marilyn J. Manco-Johnson, and Neil A. Goldenberg. "Findings of Feasibility Assessment From Multicenter Clinical Trials of Antithrombotic Therapy in Pediatric Venous Thromboembolism." Blood 118, no. 21 (November 18, 2011): 4323. http://dx.doi.org/10.1182/blood.v118.21.4323.4323.

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Abstract Abstract 4323 BACKGROUND:Two major multicenter pediatric randomized controlled clinical trials (RCTs) in pediatric venous thromboembolism (VTE) have been conducted in the last decade, and each was closed early due to poor accrual. With the recent trend in reduced federal grant support for clinical trials, an emphasis on demonstration of feasibility is critical.OBJECTIVE: In order to inform the design and execution of future RCTs in pediatric VTE, we sought to report findings of feasibility assessment from two ongoing and one proposed clinical trials in the field. METHODS: In the UNBLOCK study (ongoing phase 1 trial of bivalirudin in acute DVT; clinicaltrials.gov registration #NCT00812370), feasibility was assessed informally in 2008/9 during grant development teleconferences and early investigator meetings. In the Kids-DOTT trial (ongoing phase 3 RCT of shortened vs. conventional duration of therapy in acute VTE associated with a transient/reversible clinical risk factor; NCT00687882), feasibility was assessed in 2005 and updated in 2011 using standardized questionnaires, with response data summarized via descriptive statistics. The latter approached was also used in 2011 for the PHLO trial (proposed phase II/III RCT of catheter-directed thrombolysis followed by therapeutic anticoagulation vs. anticoagulation alone in completely veno-occlusive acute DVT of the proximal leg). RESULTS: Response rate (Kids-DOTT and PHLO questionnaires) was 100%. Number of investigative sites/principal investigators assessed and geographical distribution, by trial, were as follows: UNBLOCK: n=6 (all USA); Kids-DOTT: n=26 (25 USA, 1 Canada); PHLO: n=7 (all USA). Of the 26 site PIs in Kids-DOTT, 84% reported past experience with 5 or more trials, with a median experience of 20 per PI. Across all 3 trial feasibility assessments, all but one site used electronic health records in clinical care, and all but one investigative team had trial experience in using electronic data capture systems. With regard to size of the screening population for pediatric VTE trials, Figure 1 shows the reported average annual volume of new pediatric VTE cases managed by each Kids-DOTT investigator/site, using data from the prior 2 years. All sites reported use of inpatient/consult lists in screening efforts. CONCLUSIONS: These findings indicate appropriate site experience and capacity to execute multicenter clinical trials in pediatric VTE. Therefore, feasibility of ongoing and future trials in the field is more likely related to such issues as: suitability of funding and number of sites to targeted enrollment; experience/capabilities of the clinical coordinating and data coordinating centers; and pragmatic protocol design, particularly eligibility criteria, enrollment/randomization windows, and frequency, timing, and invasiveness of follow-up and endpoint determinations. Disclosures: No relevant conflicts of interest to declare.

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Durkalski, Valerie, Wenle Zhao, Catherine Dillon, and Jaemyung Kim. "A web-based clinical trial management system for a sham-controlled multicenter clinical trial in depression." Clinical Trials: Journal of the Society for Clinical Trials 7, no. 2 (January 18, 2010): 174–82. http://dx.doi.org/10.1177/1740774509358748.

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Schoen, Robert E. "Abstract IA016: Lessons learned from clinical trials of MUC1 peptide vaccines for cancer prevention." Cancer Prevention Research 15, no. 12_Supplement_2 (December 1, 2022): IA016. http://dx.doi.org/10.1158/1940-6215.tacpad22-ia016.

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Abstract We report on three trials of a MUC1 peptide vaccine for cancer prevention. Two trials were pilot studies evaluating vaccine immunogenicity and safety. One was in subjects with advanced colon adenomas, and the other in smokers at risk for lung cancer. The third trial was a multi-center, randomized placebo-controlled trial in subjects with advanced adenoma that included an assessment of the clinical efficacy of the vaccine to prevent recurrent adenoma. All trials successfully recruited their full complement of participants and the vaccine was well tolerated with no safety concerns. The response rate in the colon adenoma trials was 43% in the pilot study and 25% in the placebo- controlled multicenter trial. Only 10% of smokers responded to the vaccine. Higher levels of circulating myeloid derived suppressor cells (MDSC) were consistently associated with the lack of an immune response. This suggests that even in pre-malignancy immunosuppressive tendencies can impair vaccine immunogenicity. Responders to the vaccine demonstrated immune memory at one year. In the multicenter adenoma trial that evaluated the efficacy of the vaccine on adenoma recurrence, immune responders demonstrated an association with a reduced rate of adenoma recurrence. In future studies, patient selection based on circulating MDSC levels, or concomitant use of agents to counter MDSC immunosuppressive function or otherwise improve T cell function, should be considered. Citation Format: Robert E. Schoen. Lessons learned from clinical trials of MUC1 peptide vaccines for cancer prevention [abstract]. In: Proceedings of the Second Biennial NCI Meeting: Translational Advances in Cancer Prevention Agent Development (TACPAD); 2022 Sep 7-9. Philadelphia (PA): AACR; Can Prev Res 2022;15(12 Suppl_2): Abstract nr IA016.

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Kraemer, Helena Chmura, and Thomas N. Robinson. "Are certain multicenter randomized clinical trial structures misleading clinical and policy decisions?" Contemporary Clinical Trials 26, no. 5 (October 2005): 518–29. http://dx.doi.org/10.1016/j.cct.2005.05.002.

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Leclair, Valérie, Océane Landon-Cardinal, Rohit Aggarwal, Nick Bansback, Craig Campbell, Brian M. Feldman, Martin Jarry, Suzan McNamara, Barbara White, and Marie Hudson. "Proceedings of the 2019 Canadian Inflammatory Myopathy Study Symposium: Clinical Trial Readiness in Myositis." Journal of Rheumatology 47, no. 10 (June 15, 2020): 1584–86. http://dx.doi.org/10.3899/jrheum.200480.

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The Canadian Inflammatory Myopathy Study (CIMS) is a multicenter prospective cohort recruiting in 8 centers across Canada. One of the aims of CIMS is to conduct and participate in clinical trials in autoimmune inflammatory myopathies (AIM). Conducting clinical trials in rare diseases such as AIM presents challenges. During this symposium, experts in the field presented different solutions to successfully conduct clinical trials in AIM, including the importance of collaboration and careful trial design, as well as training and mentoring of young investigators.

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Coates, Elsa C., Elizabeth A. Mann-Salinas, Nicole W. Caldwell, and Kevin K. Chung. "Challenges Associated with Managing a Multicenter Clinical Trial in Severe Burns." Journal of Burn Care & Research 41, no. 3 (January 30, 2020): 681–89. http://dx.doi.org/10.1093/jbcr/iraa014.

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Abstract Managing multicenter clinical trials (MCTs) is demanding and complex. The Randomized controlled Evaluation of high-volume hemofiltration in adult burn patients with Septic shoCk and acUte kidnEy injury (RESCUE) trial was a prospective, MCT involving the impact of high-volume hemofiltration continuous renal replacement therapy on patients experiencing acute kidney injury and septic shock. Ten clinical burn centers from across the United States were recruited to enroll a target sample size of 120 subjects. This manuscripts reviews some of the obstacles and knowledge gained while coordinating the RESCUE trial. The first subject was enrolled in February 2012, 22 months after initial IRB approval and 29 months from the time the grant was awarded. The RESCUE team consisted of personnel at each site, including the lead site, a data coordination center, data safety monitoring board, steering committees, and the sponsor. Seven clinical sites had enrolled 37 subjects when enrollment stopped in February 2016. Obstacles included changes in institutional review boards, multiple layers of review, staffing changes, creation and amendment of study documents and procedures, and finalization of contracts. Successful completion of a MCT requires a highly functional research team with sufficient patient population, expertise, and research infrastructure. Additionally, realistic timelines must be established with strategies to overcome challenges. Inevitable obstacles should be discussed in the pretrial phase and continuous correspondence must be maintained with all relevant research parties throughout all phases of study.

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Schulman, Kevin A., Martin Buxton, Henry Glick, Mark Sculpher, Gladys Guzman, Janet Kong, Martin Backhouse, Jo Mauskopf, Larry Bell, and John M. Eisenberg. "Results of the Economic Evaluation of the FIRST Study: A Multinational Prospective Economic Evaluation." International Journal of Technology Assessment in Health Care 12, no. 4 (1996): 698–713. http://dx.doi.org/10.1017/s0266462300010989.

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AbstractWe present the prospective economic evaluation that served as a secondary endpoint for the FIRST study, a randomized international multicenter trial of patients with severe congestive heart failure. Although the clinical results of this study were disappointing, we demonstrated the feasibility of incorporating prospective economic evaluation in phase III clinical trials.

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SINGH, JASVINDER A., STEPHEN MURPHY, and MOHIT BHANDARI. "Assessment of the Methodologic Quality of Medical and Surgical Clinical Trials in Patients with Arthroplasty." Journal of Rheumatology 36, no. 12 (November 2, 2009): 2642–54. http://dx.doi.org/10.3899/jrheum.090333.

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Objective.To assess the methodological quality of randomized controlled trials (RCT) of medical and surgical therapy in patients with arthroplasty.Methods.We conducted a Medline database search for all arthroplasty RCT from 1997 and 2006. The quality of the methods of all eligible RCT was assessed by a trained abstractor. We used a checklist of trial quality characteristics, and the overall trial quality was assessed by 3 scales: Jadad (range 0–5), Delphi list (range 0–9), and numeric rating scale (NRS; range 1–10), based on User’s Guides to the Medical Literature.Results.A total of 196 articles were included in the analysis; most included hip (n = 81) or knee (n = 80) or both hip/knee arthroplasty (n = 19); 66 (34%) assessed pharmacological treatments, 117 (60%) nonpharmacological treatments, and 13 (7%) both. Mean (SEM) overall quality scores of arthroplasty RCT were low: Jadad score 2.36 (1.4), Delphi list 5.33 (1.6), and NRS score 4.30 (2.6). Multivariable analyses revealed that nonpharmacological intervention RCT had lower odds (odds ratio 0.28–0.39; p = 0.008–0.033) and those with no funding had lower odds (OR 0.28–0.50; p = 0.014–0.119) of being in the highest quartiles of the 3 overall quality scores. In contrast, multicenter RCT had 1.8–4.7 times higher odds of being in highest tertiles of quality scores (p = 0.017–0.185).Conclusion.Methodological deficiencies in reporting of hip/knee arthroplasty RCT offer an opportunity for improvement. Type of intervention, number of trial centers, and presence of funding were independently associated with overall trial quality. In future, multicenter RCT (rather than single-center) and modeling protocols of single-center RCT similar in rigor to multicenter RCT may improve the quality of arthroplasty RCT.

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Milovanov, S. S. "Patterns of Patient Recruitment in Clinical Studies on the Example of International Multicenter Clinical Studies (IMCTs)." Drug development & registration 12, no. 3 (August 31, 2023): 151–68. http://dx.doi.org/10.33380/2305-2066-2023-12-3-151-168.

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Introduction. Patient recruitment is one of the main quantitative and qualitative characteristics of a clinical trial. As a quantitative characteristic, the recruitment of patients is, first of all, the final figure necessary to answer the researcher's question; as a qualitative characteristic, the recruitment of patients is a process subject to influence. The recruitment of patients in the center is determined by the rate per month and allows you to gain the statistical power of the protocol, and if the recruitment of patients does not reach the planned capacity, then the capacity may not be gained and this leads to the failure of the clinical trial. Failures in patient recruitment reported in the literature lead to more than 80 % of failed clinical trials of all phases. Patient recruitment as a process is influenced by various factors, and the authors identify recruitment predictors, recruitment facilitators, and barriers to patient recruitment.Aim. To consider the general features and patterns of recruitment of patients in clinical trials on the example of international multicenter clinical trials.Materials and methods. We analyzed the quantitative characteristics of patient recruitment in 4 clinical trials with successful recruitment.Results and discussion. Despite the uniqueness of each protocol, the set of patients has its own patterns common to all clinical studies. It was studied, in particular, that the integrative assessment of the preliminary recruitment of patients by the researcher of the clinical center is not associated with an objective pool of patients and affects the rate of patient recruitment and targeted patient recruitment. We found that the number of clinical centers not recruiting patients in each study is at least 30 % of all centers involved. Three patient recruitment rates have also been identified that need to be considered when planning a clinical trial.Conclusion. We have identified patterns in patient recruitment that will help in planning clinical trials.

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Marberger, Michael, John D. McConnell, Ivy Fowler, Gerald L. Andriole, David G. Bostwick, Matthew C. Somerville, and Roger S. Rittmaster. "Biopsy Misidentification Identified by DNA Profiling in a Large Multicenter Trial." Journal of Clinical Oncology 29, no. 13 (May 1, 2011): 1744–49. http://dx.doi.org/10.1200/jco.2010.32.1646.

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Purpose The Reduction by Dutasteride of Prostate Cancer Events (REDUCE) prostate cancer risk reduction study randomly assigned 8,231 men to dutasteride or placebo for 4 years. Protocol-mandated biopsies were obtained after 2 and 4 years. After the discovery of three cases of biopsy sample misidentification in the first 2 years, all protocol-mandated biopsy samples were DNA tested to verify biopsy identity. Methods Biopsy and blood DNA profiling was performed retrospectively for the year 2 scheduled biopsies and prospectively for the year 4 scheduled biopsies. Toward the end of year 2, multiple changes were made to improve sample handling and chain of custody. Results Of the 6,458 year 2 and 4,777 year 4 biopsies, 26 biopsies reflecting 13 sample handling errors at year 2 (0.4%) and one biopsy reflecting one sample handling error at year 4 (0.02%) were confirmed to be mismatched to the patient for whom they were originally submitted. Of 6,733 reference blood samples profiled, 31 (0.5%) were found to be mismatched to the patient's verified identity profile. Sample identification errors occurred at local research sites and central laboratories. Conclusion Biopsy misidentification is a potential problem in clinical laboratories and clinical trials. Until now, biopsy misidentification has not been studied in the setting of a large, multinational clinical trial. In the REDUCE study, process improvement initiatives halfway through the trial dramatically reduced biopsy mismatches. The potential for biopsy mismatches in clinical trials and clinical practice is an under-recognized problem that requires rigorous attention to details of chain of custody and consideration of more widespread DNA identity testing.

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Bousleiman, Jamie, Massimo Napolitano, Simon Tran, Maha Hamdani, Christopher M. Faries, Kelsey Berger, Joshua Harris, et al. "Multicenter Clinical Trial to Validate Efficacy of Sundt Carotid Shunt." Journal of Vascular Surgery 74, no. 3 (September 2021): e151. http://dx.doi.org/10.1016/j.jvs.2021.06.229.

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Bousleiman, Jamie, Massimo Napolitano, Simon Tran, Maha Hamdani, Christopher Faries, Kelsey Berger, Joshua Harris, et al. "Multicenter Clinical Trial to Validate Efficacy of Sundt Carotid Shunt." Journal of Vascular Surgery 74, no. 4 (October 2021): e350. http://dx.doi.org/10.1016/j.jvs.2021.07.032.

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Manfredini, Fabio, Francesca Mallamaci, Graziella D’Arrigo, Rossella Baggetta, Davide Bolignano, Claudia Torino, Nicola Lamberti, et al. "Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial." Journal of the American Society of Nephrology 28, no. 4 (December 1, 2016): 1259–68. http://dx.doi.org/10.1681/asn.2016030378.

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Suarez, Jose I., Renee H. Martin, Eusebia Calvillo, Catherine Dillon, Eric M. Bershad, R. Loch MacDonald, John Wong, and Robert Harbaugh. "The Albumin in Subarachnoid Hemorrhage (ALISAH) Multicenter Pilot Clinical Trial." Stroke 43, no. 3 (March 2012): 683–90. http://dx.doi.org/10.1161/strokeaha.111.633958.

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Fischbach, Ellen, Joel Achtenberg, Karen Clark, Dawn Tourville, and Mae Gordon. "(Under) estimating paper storage requirements for a multicenter clinical trial." Controlled Clinical Trials 19, no. 3 (June 1998): S84. http://dx.doi.org/10.1016/s0197-2456(98)80200-6.

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Chavez, Oscar M., Joseph A. Tangrea, and Brenda K. Edwards. "Comprehensive training of study coordinators in a multicenter clinical trial." Controlled Clinical Trials 6, no. 3 (September 1985): 234. http://dx.doi.org/10.1016/0197-2456(85)90053-4.

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Alamercery, Y., P. Wilkins, and T. Karrison. "Functional equality of coordinating centers in a multicenter clinical trial." Controlled Clinical Trials 7, no. 1 (March 1986): 38–51. http://dx.doi.org/10.1016/0197-2456(86)90006-1.

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