Review article: randomised controlled trials in inflammatory bowel disease—common challenges and potential solutions. Issue 6 (7th February 2022)

• Record Type: Journal Article
• Authors: Schreiber, Stefan; Irving, Peter M.; Sharara, Ala I.; Martín‐Arranz, María Dolores; Hébuterne, Xavier; Penchev, Plamen; Danese, Silvio; Anthopoulos, Prodromos; Akhundova‐Unadkat, Gamar; Baert, Filip
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 55:Issue 6(2022)
• Page Start: 658
• Page End: 669
• Publication Date: 2022-02-07
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.16781
• Languages: English
• ISSNs: 0269-2813

Abstract

Summary: Background: Recruitment rates for Crohn's disease and ulcerative colitis clinical trials continue to decrease annually. The inability to reach recruitment targets and complete trials has serious implications for stakeholders in the inflammatory bowel disease (IBD) community. Action is required to ensure patients with an unmet medical need have access to new therapies to improve the management of their IBD. Aims: Identify challenges contributing to recruitment decline in IBD clinical trials and propose potential solutions. Methods: PubMed and Google were used to identify literature, regulatory guidelines and conference proceedings related to IBD clinical trials and related concepts. Data on IBD clinical trials conducted between 1989 and 2020 were extracted from the Trialtrove database. Results: Key aspects that may improve recruitment rates were identified. An increasingly patient‐centric approach should be taken to study design including improvements to the readability of key trial documentation and inclusion of patient representatives in trial planning. Placebo is unappealing to patients; approaches including platform trials should be explored to minimise placebo exposure. Non‐invasive imaging, biomarkers and novel digital endpoints should continue to be examined to reduce the burden on patients. Reducing the administrative burden associated with trials via the use of electronic signatures, for example, may benefit study sites and investigators. Changes implemented to IBD trials during the COVID‐19 pandemic provided examples of how trial conduct can be rapidly and constructively adapted. Conclusions: To improve recruitment in Crohn's disease and ulcerative colitis trials, the IBD community should address a broad range of issues related to clinical trial conduct. Abstract : Recruitment rates for inflammatory bowel disease (IBD) clinical trials continue to decrease annually. The inability to reach recruitment targets and complete clinical trials has serious implications. In this article, we explore steps that can be taken by stakeholders in the IBD clinical trial space to potentially improve recruitment rates and ultimately, bring new treatment options to patients with IBD as quickly and safely as possible.