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Clinical Trials for Inflammatory Bowel Disease: Global Guidance During the COVID-19 Pandemic
Walter Reinisch1, Silvio Danese2,3, Laurent Peyrin-Biroulet4
1Department of Internal Medicine III, Division Gastroenterology & Hepatology, Medical University of Vienna, Vienna, Austria.
Abstract:
The severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]-causing coronavirus disease [COVID]-19 pandemic poses major challenges for patients with inflammatory bowel disease [IBD] to be recruited and maintained in clinical trials. However, clinical trials offer patients who have failed multiple drugs access to study medications with alternative modes of action and the potential for relief from inflammation-mediated symptoms. Therefore, the continuation of clinical trials in IBD during the COVID-19 pandemic is important both for participants and for the community of IBD patients, due to the dire need for an expanded therapeutic armamentarium. As the safety of patients in clinical trials is the leading principle, we are providing ten specific rules to guide patients and principal investigators safely through the challenging time.
Insights
Clinical trials for inflammatory bowel disease (IBD) are crucial during the COVID-19 pandemic. Ten rules are provided to ensure patient safety and trial continuation for new IBD treatments.
Area of Science:
- Gastroenterology
- Clinical Trials
- Infectious Diseases
Background:
- The COVID-19 pandemic created significant hurdles for recruiting and retaining patients with inflammatory bowel disease (IBD) in clinical trials.
- Despite challenges, clinical trials offer vital access to novel therapies for IBD patients who have not responded to existing treatments.
Purpose of the Study:
- To outline essential guidelines for the safe continuation of IBD clinical trials during the COVID-19 pandemic.
- To ensure the safety of participants and investigators while maintaining research progress.
Main Methods:
- Development of ten specific safety protocols and recommendations.
- Guidance tailored for both IBD patients and principal investigators.
Main Results:
- Established a framework for navigating the complexities of conducting IBD clinical trials amidst a global health crisis.
- Provided actionable strategies to mitigate risks associated with patient recruitment and trial participation during the pandemic.
Conclusions:
- Continuing IBD clinical trials during the pandemic is imperative for advancing treatment options.
- Patient safety remains paramount, necessitating adherence to specific guidelines for successful trial management.
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