Lack of participants
The amount of time spent recruiting participants to meet a clinical trial’s required sample size seriously stalls the process of getting FDA approval for any new IBD treatment. This is a senseless problem, considering there’s over 1,500 clinical trials available for IBD. And, as mentioned above, research coordinators should always disclose any requirements and predicted time commitments to prospective participants. But, the recruitment problem persists.
This challenge isn’t unique to IBD trials, either. A 2015 analysis found that almost one fifth of registered clinical trials that closed early did so because recruitment was insufficient to the trial’s necessary sample size. When it comes to a condition as debilitating as IBD, it’s especially damaging when clinical trials are interrupted or cancelled altogether due to lack of enrollment.