284. The Sildenafil therapy in dismal prognosis early-onset intrauterine growth restriction randomized controlled trials (STRIDER RCTs): A consortium approach

Abstract

Introduction The Global Obstetrics Network (GONet) initiative facilitates global collaboration in obstetrics research. The STRIDER Consortium is one such initiative -a consortium of four independently funded and powered trials (Australasia, UK, Netherlands, and Canada) that have a shared protocol (that includes a planned individual participant data meta-analysis) and harmonised data definitions and platform. Objective To establish a centralised clinical trial and database management infrastructure for the STRIDER consortium. Methods The STRIDER Coordinating Centre, University of British Columbia, created an electronic case report form (eCRF) database on REDCap for a central repository with role-based access control, and partnered with the BC HIV Trials Network to provide a participant randomisation system. The Coordinating Centre further developed an in–house program (iSTAR), allowing for customizations in participant randomisation, drug management, and improvements in eCRF integration. The randomisation algorithm generated in R software guarantees balanced allocations across treatment groups. The drug management system monitors inventory at each site and provides alerts if inventory falls below pre-determined thresholds, thus creating a continuous flow of supply for participants. To ensure data quality and patient safety, the Coordinating Centre developed online unblinding process, querying programing with validation rules and implemented processes with trial coordinators, allowing timely monitoring of data and trial activities. Results The Coordinating Centre provided centralised clinical operation and database management support to more than 50 sites in five countries. The SCC successfully supported the completion of STRIDER UK and STRIDER NZAus, recruiting 135 and 122 participants respectively. Currently, Dutch STRIDER and STRIDER Canada have recruited 192/354 and 20/90 participants respectively. Discussion Conducting trials as a consortium helps streamline clinical research infrastructure and promotes unified data collection and safety monitoring processes, thereby improving trial quality. Running clinical trials as a consortium can benefit patients and funders, increases research collaboration, and is cost-effective.