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THE IMPORTANCE OF METHODS FOR SITE PERFORMANCE EVALUATION IN REPRIEVE, A LONGITUDINAL, GLOBAL, MULTICENTER TRIAL
Fulda, Evelynne S. et al. | Date Issued: 2023
Author
Fulda, Evelynne S.
Fichtenbaum, Carl J.
Kileel, Emma M.
Zanni, Markella V.
Aberg, Judith A.
Malvestutto, Carlos
Cardoso, Sandra Wagner
Berzins, Baiba
Lira, Rita
Harden, Regina
Robbins, Gregory
Martinez, Maria
Nieves, Sylvia Davila
McCallum, Sara
Cruz, Jorge Leon
Umbleja, Triin
Sprenger, Heather
Giguel, Francoise
Bone, Frederic
Wood, Ken
Byroads, Mark
Paradis, Kayla
Lu, Michael T.
Douglas, Pamela S.
Ribaudo, Heather J.
Grinspoon, Steven K.
Fitch, Kathleen V.
Affilliation
Metabolism Unit. Massachusetts General Hospital and Harvard Medical School. Boston, MA, USA.
University of Cincinnati College of Medicine. Division of Infectious Diseases. Cincinnati, USA.
Metabolism Unit. Massachusetts General Hospital and Harvard Medical School. Boston, MA, USA.
Metabolism Unit. Massachusetts General Hospital and Harvard Medical School. Boston, MA, USA.
Icahn School of Medicine at Mount Sinai. Division of Infectious Diseases. New York, NY, USA.
Ohio State University Medical Center. Division of Infectious Diseases. Columbus, OH, USA.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Northwestern University - Feinberg School of Medicine. Division of Infectious Diseases. Chicago, IL, USA.
Hospital Nossa Senhora da Conceição. Porto Alegre, RS, Brasil.
UIC Project Wish. Chicago, IL, USA.
Massachusetts General Hospital. Division of Infectious Diseases. Boston, MA, USA.
Center for Clinical and Translational Sciences. UTHealth. Houston, TX, USA.
Puerto Rico Medical Center. Proyecto ACTU. San Juan, Puerto Rico.
Metabolism Unit. Massachusetts General Hospital and Harvard Medical School. Boston, MA, USA.
Harvard T.H. Chan School of Public Health. Center for Biostatistics in AIDS Research. Boston, MA, USA.
Harvard T.H. Chan School of Public Health. Center for Biostatistics in AIDS Research. Boston, MA, USA.
Frontier Science Foundation. Amherst, NY, USA.
Massachusetts General Hospital. Harvard Virology Specialty Laboratory. Boston, MA, USA.
Frontier Science Foundation. Amherst, NY, USA.
Frontier Science Foundation. Amherst, NY, USA.
Frontier Science Foundation. Amherst, NY, USA.
Massachusetts General Hospital and Harvard Medical School. Cardiovascular Imaging Research Center. Department of Radiology. Boston, MA, USA.
Massachusetts General Hospital and Harvard Medical School. Cardiovascular Imaging Research Center. Department of Radiology. Boston, MA, USA.
Duke University Research Institute. Duke University School of Medicine. Durham, NC, USA.
Harvard T.H. Chan School of Public Health. Center for Biostatistics in AIDS Research. Boston, MA, USA.
Metabolism Unit. Massachusetts General Hospital and Harvard Medical School. Boston, MA, USA.
Metabolism Unit. Massachusetts General Hospital and Harvard Medical School. Boston, MA, USA.
Abstract
Background: REPRIEVE, the Randomized Trial to Prevent Vascular Events in HIV, is a multicenter, primary prevention trial evaluating whether a statin can prevent major cardiovascular events in people with HIV. REPRIEVE is conducted at >100 clinical research sites (CRSs) globally. Detailed, comprehensive, and novel methods for evaluating and communicating CRS performance are required to ensure trial integrity and data quality. In this analysis we describe a comprehensive multidimensional methodology for evaluating CRS performance. Methods: The REPRIEVE Data Coordinating and Clinical Coordinating Centers developed a robust system for evaluation of and communication with CRSs, designed to identify potential issues and obstacles to performance, provide real-time technical support, and make recommendations for process improvements to facilitate efficient trial execution. We describe these systems and evaluate their impact on participant retention, data management, and specimen management from 2019 to 2022, corresponding to the period from end of recruitment to present. This evaluation was based on pre-defined metrics, regular reviews, and bidirectional communication. Results: Participant retention, data management, and specimen management all remained steady over the three-year period, although metrics varied by country of enrollment. Targeted messaging relating to certain performance metrics was effective. Conclusion: Site performance is vital to ensure trial integrity and achievement of key trial goals. This analysis demonstrates that utilization of a comprehensive approach allows for a thorough evaluation of CRS performance, facilitates data and specimen management, and enhances participant retention. Our approach may serve as a guidepost for maximizing future large-scale clinical trials' operational success and scientific rigor.
Keywords
Site Performance
Clinical Trial Management
Participant Retention
Data Management
 
Publisher
Elsevier
Citation
FULDA, Evelynne S. et al. The importance of methods for site performance evaluation in REPRIEVE, a longitudinal, global, multicenter trial. Contemporary Clinical Trials, v. 124, p. 1-20, Jan. 2023.
DOI
10.1016/j.cct.2022.107035
ISSN
1551-7144