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Updated: Jul 20, 2026
Dynamic Adhesion Assay for the Functional Analysis of Anti-adhesion Therapies in Inflammatory Bowel Disease
Published on: September 20, 2018
Review article: randomised controlled trials in inflammatory bowel disease-common challenges and potential solutions
Stefan Schreiber1, Peter M Irving2, Ala I Sharara3
1Department Internal Medicine I, University Hospital Schleswig-Holstein, Christian-Alrechts-Unversity, Kiel, Germany.
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.
Insights
Declining recruitment in inflammatory bowel disease (IBD) clinical trials hinders patient access to new therapies. Implementing patient-centric approaches and reducing trial burdens are key to improving enrollment for Crohn's disease and ulcerative colitis studies.
Area of Science:
- Gastroenterology
- Clinical Trial Management
- Patient Recruitment
Background:
- Recruitment rates for Crohn's disease and ulcerative colitis clinical trials are declining.
- This impacts the inflammatory bowel disease (IBD) community and patient access to novel therapies.
- Urgent action is needed to improve IBD trial enrollment.
Purpose of the Study:
- Identify challenges contributing to decreased recruitment in IBD clinical trials.
- Propose actionable solutions to enhance patient enrollment in these studies.
Main Methods:
- Literature review using PubMed and Google.
- Analysis of regulatory guidelines and conference proceedings.
- Extracted data from the Trialtrove database for IBD trials (1989-2020).
Main Results:
- Patient-centric study design is crucial, including improved documentation readability and patient involvement in planning.
- Minimizing placebo exposure through methods like platform trials is recommended.
- Reducing patient burden via non-invasive methods and streamlining administrative processes (e.g., electronic signatures) is vital.
- Adapting trial conduct, as seen during the COVID-19 pandemic, offers valuable lessons.
Conclusions:
- The IBD community must address multifaceted issues in clinical trial conduct to improve recruitment.
- Implementing proposed solutions can enhance enrollment for Crohn's disease and ulcerative colitis trials.
- Improving trial efficiency and patient experience is essential for advancing IBD treatment.
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