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Journal articles on the topic 'Multicenter clinical trial'

Author: Grafiati

Published: 7 July 2024

Last updated: 31 July 2025

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1

Pucker, Andrew D., Nicole Derthick, and Lanita Scott. "Running the enrollment numbers on ophthalmic clinical trials in the United States." Optometry and Vision Science 101, no. 8 (2024): 523–29. http://dx.doi.org/10.1097/opx.0000000000002174.

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SIGNIFICANCE This is one of the first reports to summarize the enrollment metrics for ophthalmology trials completed in the United States (US). PURPOSE This study aimed to describe US ophthalmology clinical trial enrollment metrics to facilitate planning and budgeting of US Food and Drug Administration–regulated ophthalmological drugs trials. METHODS A GlobalData PLC search was conducted on or before February 27, 2024, to evaluate the clinical trial landscape for completed ophthalmology clinical trials conducted in the US. The primary search contained only the term “ophthalmology,” which was r

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Justice, Jamie N., George A. Kuchel, Nir Barzilai, and Stephen Kritchevsky. "BIOMARKER STRATEGIES FOR GEROSCIENCE-GUIDED CLINICAL TRIALS." Innovation in Aging 3, Supplement_1 (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 o

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Nishio, Teiji, Mitsuhiro Nakamura, Hiroyuki Okamoto, 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 (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 trial

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

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Chung, Kevin C., Sunitha Malay, and Melissa J. Shauver. "The Complexity of Conducting a Multicenter Clinical Trial." Plastic and Reconstructive Surgery 144, no. 6 (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 (2004): 1801–4. http://dx.doi.org/10.1016/j.transproceed.2004.07.037.

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7

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 (1994): 619–20. http://dx.doi.org/10.1016/s0196-0644(94)80337-4.

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8

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

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9

Cauch, Karen. "Early patient accrual for a multicenter clinical trial." Controlled Clinical Trials 12, no. 5 (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, et al. "Digitally Enhanced Insulin Therapy—A Multicenter Clinical Trial." Diabetes 67, Supplement 1 (2018): 353—OR. http://dx.doi.org/10.2337/db18-353-or.

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

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12

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 (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 t

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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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16

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 (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

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Trimble, E. L., J. Davis, P. Disaia, et al. "Clinical trials in gynecological cancer." International Journal of Gynecologic Cancer 17, no. 3 (2007): 547–56. http://dx.doi.org/10.1136/ijgc-00009577-200705000-00001.

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The Gynecologic Cancer Intergroup is comprised representatives from international gynecological cancer trials organizations, which collaborate in multicenter studies to answer the clinical challenges in gynecological cancer. This review article highlights the key clinical questions facing clinical trialists over the next decade, the information and infrastructure resources available for trials, and the methods of trial development. We cover human papillomavirus (HPV)-associated neoplasia, including cervical cancer, together with endometrial cancer, ovarian cancer, and vulvar cancer. Infrastruc

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18

Vermeersch, Kristina, Bénédicte Demeyere, Karen Denaux, et al. "Challenges and threats of investigator-initiated multicenter randomized controlled trials: the BACE trial experience." International Journal of Clinical Trials 6, no. 4 (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 hosp

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19

Husband, J., C. Cassidy, C. Leinberry, et al. "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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20

Shin, Youngbin, Kyung Won Kim, Amy Junghyun Lee, et al. "A Good Practice–Compliant Clinical Trial Imaging Management System for Multicenter Clinical Trials: Development and Validation Study." JMIR Medical Informatics 7, no. 3 (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 rat

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21

Harris, Paul A., Consuelo H. Wilkins, Karen Lane, et al. "Enhancing Multicenter Trials With the Trial Innovation Network's Initial Consultation Process." JAMA Network Open 8, no. 5 (2025): e2512926. https://doi.org/10.1001/jamanetworkopen.2025.12926.

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This qualitative study describes the Trial Innovation Network's initial consultation process, which provides researchers with resources and recommendations to address complex aspects of planning and conducting clinical trials.

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22

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

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23

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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24

Aitken, Leanne M., Michele M. Pelter, Beverly Carlson, et al. "Effective Strategies for Implementing a Multicenter International Clinical Trial." Journal of Nursing Scholarship 40, no. 2 (2008): 101–8. http://dx.doi.org/10.1111/j.1547-5069.2008.00213.x.

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25

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

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26

Ginsberg, Myron D., Yuko Y. Palesch, Renee H. Martin, et al. "The Albumin in Acute Stroke (ALIAS) Multicenter Clinical Trial." Stroke 42, no. 1 (2011): 119–27. http://dx.doi.org/10.1161/strokeaha.110.596072.

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27

Lass, Jonathan, Judy Gordon, Alan Sugar, et al. "A PROSPECTIVE MULTICENTER CLINICAL TRIAL OF OPTISOL CONTAINING STREPTOMYCIN." Cornea 12, no. 1 (1993): 92. http://dx.doi.org/10.1097/00003226-199301000-00055.

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28

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 (2010): 665–71. http://dx.doi.org/10.1097/nmd.0b013e3181ef3627.

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29

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 (1996): S133—S134. http://dx.doi.org/10.1016/0197-2456(96)84688-5.

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30

Chancellor, Michael, H. Barton Grossman, John Konnak, et al. "Biocarbon ureterostomy device for urinary diversion Multicenter clinical trial." Urology 34, no. 1 (1989): 18–21. http://dx.doi.org/10.1016/0090-4295(89)90149-0.

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31

Schulman, Kevin A., Martin Buxton, Henry Glick, et al. "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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32

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 i

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33

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 (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

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34

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 (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 UNBLO

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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 refracto

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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 (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 9

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Leclair, Valérie, Océane Landon-Cardinal, Rohit Aggarwal, et al. "Proceedings of the 2019 Canadian Inflammatory Myopathy Study Symposium: Clinical Trial Readiness in Myositis." Journal of Rheumatology 47, no. 10 (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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38

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 (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

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39

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 (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, et al. "Multicenter trial of naloxone in alzheimer's disease." Annals of Neurology 25, no. 4 (1989): 404–6. http://dx.doi.org/10.1002/ana.410250413.

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41

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 (2010): 174–82. http://dx.doi.org/10.1177/1740774509358748.

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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 (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 articl

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Drye, Lea T., Anne S. Casper, Alice L. Sternberg, Janet T. Holbrook, Gabrielle Jenkins, and Curtis L. Meinert. "The transitioning from trials to extended follow-up studies." Clinical Trials 11, no. 6 (2014): 635–47. http://dx.doi.org/10.1177/1740774514547396.

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Background: Investigators may elect to extend follow-up of participants enrolled in a randomized clinical trial after the trial comes to its planned end. The additional follow-up may be initiated to learn about longer term effects of treatments, including adverse events, costs related to treatment, or for reasons unrelated to treatment such as to observe the natural course of the disease using the established cohort from the trial. Purpose: We examine transitioning from trials to extended follow-up studies when the goal of additional follow-up is to observe longer term treatment effects. Metho

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Coyle, Douglas, and Michael F. Drummond. "ANALYZING DIFFERENCES IN THE COSTS OF TREATMENT ACROSS CENTERS WITHIN ECONOMIC EVALUATIONS." International Journal of Technology Assessment in Health Care 17, no. 2 (2001): 155–63. http://dx.doi.org/10.1017/s0266462301105015.

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Objectives: Assessments of health technologies increasingly include economic evaluations conducted alongside clinical trials. One particular concern with economic evaluations conducted alongside clinical trials is the generalizability of results from one setting to another. Much of the focus relating to this topic has been on the generalizability of results between countries. However, the characteristics of clinical trial design require further consideration of the generalizability of cost data between centers within a single country, which could be important in decisions about adoption of the

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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 (2005): 518–29. http://dx.doi.org/10.1016/j.cct.2005.05.002.

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46

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 (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 coordin

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47

Ansah, Patrick, Bharat Parmar, Dickens Onyango, et al. "Prospective, Multicenter Study to Assess the Effect of the Speaking Book on Patients' Understanding of Clinical Research Knowledge: The SOUND Study." Blood 144, Supplement 1 (2024): 2441. https://doi.org/10.1182/blood-2024-206983.

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Introduction: Communicating complex clinical trial information to potential participants with varying literacy levels and health conditions can be challenging. Ensuring health equity and promoting clinical trial diversity requires building trust with patients from diverse sociocultural backgrounds, particularly those with low literacy levels. Exploring new communication strategies such as interactive audio-visual formats in their native language can improve participants' understanding of, and participation in, clinical trials, particularly when it is tailored to their literacy levels. The “Spe

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48

Marberger, Michael, John D. McConnell, Ivy Fowler, et al. "Biopsy Misidentification Identified by DNA Profiling in a Large Multicenter Trial." Journal of Clinical Oncology 29, no. 13 (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

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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 (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

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Holbrook, Janet T., John H. Kempen, Nancy A. Prusakowski, Michael M. Altaweel, and 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, no. 6 (2011): 736–43. http://dx.doi.org/10.1177/1740774511423682.

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Abstract:

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 acet

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