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IBD drug developers, CROs and regulators must team to solve trial challenges says study

Posted by on 03 May 2023
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Difficulties finding patients for clinical trials is holding back the development of treatments for inflammatory bowel disease (IBD) say researchers who say increased collaboration is key to reversing the trend.

The comments are based on a study published in the Journal of Crohn’s and colitis that sought to understand declining participation rates in IBD studies over the past few years which, the authors say, “has led to delays, increased costs and failures to develop novel treatments.”

Trialists from academic centers and pharmaceutical companies involved in IBD clinical research contributed to the study, sharing details about protocol design, sites involved, physician training and patient involvement in a bid to understand the decline.

The results suggest that while enrolment in IBD studies is declining for a variety of reasons, increased study complexity is a major issue.

“The main reasons identified included the overall increased demands for trials, the high screen failure rates, particularly in Crohn’s disease, partly due to the lack of correlation between clinical and endoscopic activity, and the use of complicated endoscopic scoring systems not reflective of the totality of inflammation.”

“In addition, complex trial protocols with restrictive eligibility criteria, increasing burden of procedures and administrative tasks enhance the need for qualified resources in study coordination.”

Engagement challenges

The study also highlighted some challenges associated with patient and physician engagement.
“At the physician level, lack of dedicated time and training is crucial. From the patients’ perspective, long washout periods from previous medications and protocol requirements not reflecting clinical practice, such as prolonged steroid management and placebo exposures, limit their participation in clinical trials.”


Solving the IBD trial recruitment challenges will necessitate some significant changes to clinical trial design and operation according to the authors, who say a team effort is needed.

“This joint effort is proposed as the basis for profound clinical trial transformation triggered by investigative centers, contract research organizations, sponsors and regulatory agencies.”

Whether such change is possible remains to be seen. However, for the drug industry there are some considerable financial incentives.

According to one recent study the global inflammatory bowel disease market size was worth $20.33 billion in 2022 and is predicted to grow 3.6% between 2023 and 2030.


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