The importance of methods for site performance evaluation in REPRIEVE, a longitudinal, global, multicenter trial

• DOI: 10.1016/j.cct.2022.107035
• Publication Date: 2022-11-30T16:23:01Z
• Authors: Evelynne S. Fulda; Carl J. Fichtenbaum; Emma M. Kileel; Markella V. Zanni; Judith A. Aberg; Carlos Malvestutto; Sandra Wagner Car...; Baiba Berzins; Rita Lira; Regina Harden; Gregory Robbins; Maria Martinez; Sylvia Davila Nieves; Sara McCallum; Jorge Leon Cruz; Triin Umbleja; Heather Sprenger; Francoise Giguel; Frederic Bone; Ken Wood; Mark Byroads; Kayla Paradis; Michael T. Lu; Pamela S. Douglas; Heather J. Ribaudo; Steven K. Grinspoon; Kathleen V. Fitch
• Keywords: 03 medical and health sciences; Communication; Humans; HIV Infections; Hydroxymethylglutaryl-CoA Reductase Inhibitors; 0305 other medical science; Article; 3. Good health

REPRIEVE, the Randomized Trial to Prevent Vascular Events in HIV, is a multicenter, primary prevention trial evaluating whether statin can prevent major cardiovascular events people with HIV. REPRIEVE conducted at >100 clinical research sites (CRSs) globally. Detailed, comprehensive, and novel methods for communicating CRS performance are required ensure integrity data quality. In this analysis we describe comprehensive multidimensional methodology performance. The Data Coordinating Clinical Centers developed robust system evaluation of communication CRSs, designed identify potential issues obstacles performance, provide real-time technical support, make recommendations process improvements facilitate efficient execution. We these systems evaluate their impact on participant retention, management, specimen management from 2019 2022, corresponding period end recruitment present. This was based pre-defined metrics, regular reviews, bidirectional communication. Participant all remained steady over three-year period, although metrics varied by country enrollment. Targeted messaging relating certain effective. Site vital achievement key goals. demonstrates that utilization approach allows thorough facilitates enhances retention. Our may serve as guidepost maximizing future large-scale trials' operational success scientific rigor. ClinicalTrials.gov Identifier: NCT02344290