In my last post I covered facts on enrollment delays from my latest ebook. In this post I’m going to cover the seven most common reasons for these enrollment challenges.
There are a number of reasons that sites may struggle or fail to enroll patients – we could write an entire novel on them! Here are the most common:
Protocol Criteria
Some professionals will argue that the industry is too restrictive in protocol requirements. This may be true in some instances, but there are reasons for being stringent as well, especially in earlier phase trials.
Identifying Patients
There are many factors that can make patient identification a challenge; patient demographics, location, and indication are all factors that can cause hurdles for sites.
Screen Failures
Sites often receive a protocol and think that a much higher number of patients coming through their practice would qualify. Often when these patients are actually brought in for screening, they don’t qualify for any number of reasons.
Consent
Consent can be a large hurdle when working with children or trials in the early stages.
Competing Sites
Currently there are more clinical trials operating than ever before. Competing studies may certainly be tapping into your patient pool.
Site Fatigue
Site fatigue is often overlooked. The longer a trial goes on, the harder it is to keep the attention and enthusiasm of the sites and their teams. Once sites lose motivation, it is often tough to revive it.
Fairness of Grant
If investigators are not paid as well as they are for other studies, yours may not receive the attention it needs. The grant needs to be competitive.
Typically, the strongest factors hindering enrollment are screen failures and the inability to identify enough qualified patients, followed not too far behind by excessive protocol criteria. These three factors should be on top of the mind throughout the planning stages in order to prepare sites proactively.
These are the most common patient enrollment challenges faced by the industry. For more information on how to turn around a trial with low patient enrollment, be sure to download my ebook here.