P023 CROHN’S DISEASE AND ULCERATIVE COLITIS PATIENT PERSPECTIVES ON PARTICIPATION IN IBD CLINICAL TRIALS

Abstract

Clinical trial recruitment is often the rate-limiting step in the development of new treatments reaching patients across all disease states. With many competing clinical trials available for inflammatory bowel diseases (IBD) patients, it is important to understand patient perceptions of clinical trial participation to improve recruitment and retention. We aimed to examine the specific challenges and barriers that might be reducing IBD patient enrollment and potential methods to overcome these barriers. Five in-person patient focus groups were conducted from February through May 2016 using two facilitation guides. Transcript analysis with the tidytext package in R. The five focus groups included a total of 34 participants. Participants discussed barriers, including fears related to participating in trials, disease severity at onset of trial, potential adverse effects, time constraints, and the influence of both their primary IBD provider and their support network. Methods to improve participation included better communication to patients on trial, reduced trial length and time commitment, lower placebo rates (20% was considered tolerable according to participants), available open label extension, and support of the patient’s primary IBD provider. Patients also expected a high level of professionalism, customer service, and compassion in the conduct of a trial. This is the first study to examine patient perceptions for IBD clinical trial enrollment, including barriers to participation and methods to improve participation. Fear and misunderstanding of clinical trials, engagement with primary gastroenterologists, limiting time demands, and limiting the impact on work and family were found to be important for clinical trial participation. Creative solutions to these problems could lead to greater participation in IBD clinical trials and more rapid advancement of new therapies to clinical approval and use.