PWE-61 an Early Evaluation of Participant Recruitment and Compliance Following the Virtualisation of RELIEVE IBS-D Trial

Introduction Irritable bowel syndrome (IBS) is a common condition but recruitment to IBS clinical trials has been challenging due to non-specialist follow-up, poor diagnostic coding, and complexity of ROME IV criteria. The RELIEVE-IBSD study was delivered partly as a traditional site-dependent trial (SDT) and a remote virtual trial (VT). We aimed to compare recruitment efficacy and study compliance (drop-outs) in the two forms of the study. Methods RELIEVE IBS-D is a commercially sponsored double-blind, placebo-controlled, multi-centre study to test the efficacy and safety of intestinal adsorbents in diarrhoea predominant IBS (IBS-D). Recruitment began in November 2018 with a target to recruit 430 participants across 28 sites. In April 2020, with approximately half the target reached, the pandemic paused or stopped recruitment in many sites. A single site (Newcastle) developed a virtual recruitment process that commenced in September 2020. In total 269 patients were randomised via the SDT and 161 via the VT. Recruitment rates were compared for the SDT pre-pandemic, open sites continuing to recruit SDT post-pandemic and a single site (Newcastle) running a VT. Drop-out rates of the first 80 cases completing the RCT phase of the SDT and VT were compared. Results In April 2020, 232 participants (53.9%) had been randomised before the study was paused. VT started in September 2020 and target achieved in April 2021. Recruitment rates for different periods are in the table. Analysis of study compliance (8 weeks) of the first 80 sequentially randomised participants showed a drop-out rate of 13/80 (16%) for the SDT and 4/80 (5%) for the VT (p<0.05). Conclusions Enhanced recruitment techniques can significantly increase recruitment rates. However, the geographical exclusion created by SDTs limits the effectiveness of recruitment, which can be enhanced many-fold by a VT design. Preliminary evidence suggests that VTs may provide lower levels of patient withdrawals. The success of this study has been facilitated by close cooperation of the sponsor and NHS delivery site, together with involvement of patients in trial design.