Toward Patient Centricity: Why Do Patients With Inflammatory Bowel Disease Participate in Pharmaceutical Clinical Trials? A Mixed-Methods Exploration of Study Participants

Virginia Solitano; Heather Prins; Meagan Archer; Leonardo Guizzetti; Vipul Jairath

doi:10.1093/crocol/otae019

Toward Patient Centricity: Why Do Patients With Inflammatory Bowel Disease Participate in Pharmaceutical Clinical Trials? A Mixed-Methods Exploration of Study Participants

Crohns Colitis 360. 2024 Mar 15;6(2):otae019. doi: 10.1093/crocol/otae019. eCollection 2024 Apr.

Authors

Virginia Solitano¹, Heather Prins¹, Meagan Archer¹, Leonardo Guizzetti², Vipul Jairath^{1

3}

Affiliations

¹ Division of Gastroenterology, Department of Medicine, Western University, London, ON, Canada.
² Independent Researcher, London, ON, Canada.
³ Department of Epidemiology and Biostatistics, Western University, London, ON, Canada.

Abstract

Background: A better understanding of motivations to participate as well as recommendations to reduce barriers to enrollment may assist in design of future clinical trials.

Methods: We developed a 32-item electronic questionnaire to explore motivations, experiences, and recommendations of inflammatory bowel disease patients, who had participated in pharmaceutical clinical trials in a tertiary center in Canada over the last decade. We employed a mixed-methods approach that integrates both quantitative and qualitative research methods.

Results: We distributed a total of 69 e-mails with surveys and received 46 responses (66.6% response rate). Study participants were mostly male (27/46, 58.7%), non-Hispanic White (43/46, 93.5%), with a mean age of 45.5 years (SD 10.9). Most decided to participate in a clinical trial to benefit future patients (29/46, 63.0%). Half of the participants (23/46, 50.0%) reported they were worried about the possibility of receiving placebo, although the majority (29/46, 63.0%) understood they could improve on placebo. The most challenging aspect reported was the number and length of questionnaires (15/46, 32.6%), as well as the number of colonoscopies (14/46, 30.4%). Strategies recommended to increase enrollment were reduction of the chance of receiving placebo (20/46, 43.5%), facilitating inclusion of patients who have failed multiple therapies (20/46, 43.5%), allowing virtual visits (18/46, 39.1%), including subtypes of disease traditionally excluded from trials (16/46, 34.8%) and improving outreach to underrepresented populations (13/46, 28.3%). The vast majority (37/46, 80.4%) reported their experience of participation to be better than expected.

Conclusions: These results should help inform the design of future clinical trials with a focus on patient-centricity.

Keywords: Crohn’s disease; clinical trials; combined research methods; design; experimental studies; subject involvement; trial framework; ulcerative colitis disease.