The inability to address the enrollment problem in clinical trials has many reasons but one of the big ones is – we’re not curious enough. The lack of curiosity results in short term, narrow solutions to a long term, broad problem. We use the latest enrollment funnel that works for one study and are confused when it gets clogged and doesn’t work for the next study.
Have you ever watched the show Ted Lasso?
In one episode, there’s a scene in a bar where the nemesis challenges Ted to a darts competition. The person was very confident in their ability to beat Ted in the game and placed a big bet after asking Ted if he liked darts. Ted responded that he thought they were ok. With the game on the line, as Ted prepares for his final turn, Ted started telling the story of how he came across a quote by Walt Whitman that said, “Be Curious, Not Judgemental”. He goes on to explain that when he was a kid, he was picked on by other boys. He came to the realization that the other boys were simply not curious. They judged him without knowing him and weren’t curious about him. At this point, Ted turns to his darts opponent and explains that if the boys were curious, they might have asked if he played much darts. They would have learned that he played darts every weekend with his dad. At that point, Ted launches his final shot and wins the game and the bet.
The clinical trial industry lacks curiosity and rushes to judgement when trying to tackle the enrollment problem.
We’re not curious enough. We don’t ask enough questions. We don’t ask the right questions. We get some answers, and we make a quick judgement when we should have continued to ask questions.
This leads us to implement recruitment solutions that may have small, temporary success – perhaps for a couple of studies or a few sites. We dive into solutions that may have some potential but fall short because we stopped asking questions and we didn’t implement a long-term solution that got to the root of the issue.
How do we evaluate proposals for recruitment strategies in a clinical trial? If we follow the “Be Curious” strategy, we need to start with questioning to ensure we understand as many of the challenges to enrollment in the study. This questioning must start prior to conducting feasibility for the study. Many believe that the feasibility questionnaire process is the time to learn about potential enrollment problems. Sponsors will never obtain the information they need by reviewing the answers to feasibility questionnaires. The questionnaires are plagued with poorly worded questions and the sites answering the questionnaire are only concerned with getting selected. They are under pressure to respond with completed questionnaires as soon as possible. With some rare exceptions, sites will not share information that might keep them from being selected for the study. It’s that unshared information that the sponsor needs to know, but the broken feasibility process prevents sometimes critical information from being disclosed.
When a sponsor is committed to researching an indication, they should get to know a wide variety of sites – the high recruiting sites, the middle of the pack sites and the low performing sites. Notice the term KOL is not used here. Each group of sites may have different challenges with a study design or indication. Experienced investigators and coordinators should be engaged together to review and identify clinical operations issues and challenges in the indication studied. The study design, protocol and list of vendors should be shared with a representation from the groups above. The sites should be engaged and paid well for their evaluation of the study details and input on enrollment. Understanding what issues each group will face is integral to designing and executing a study that will optimize enrollment for all. Think of the impact to study timelines if the low recruiting sites were able to add another 1-2 participants, the middle crowd another 3-4 and the top sites another 5-6…
Once the issues are identified, don’t stop asking questions there. This is only the beginning of being curious.
Clinical Research 
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