How Protocol Complexity is Impacting Patient Recruitment

Medicine is advancing every day, and treatments are becoming more and more precise. This is, of course, good news for patients in need of new and different treatment options. But as treatments become more targeted, so do clinical trials. It can feel like it’s never been more difficult to recruit patients to take part in clinical trials than it is today.

This difficulty is tied to clinical trial protocol complexity. The August 2018 Tufts Center for the Study of Drug Development Impact Report took a careful look at 9,737 protocols from 178 pharmaceutical and biotechnology companies. Their analysis revealed that the total average number of endpoints in a given protocol increased 86% between 2001-2005 and 2011-2015. Of course, the number of procedures required to support those endpoints increased as well. The Report noted that based on procedures required, Phase 1 and II clinical trials tend to be the most complex, but Phase III trials have seen the highest increase in complexity in the last decade.

Protocol complexity's impact on recruitment plays out in recruitment statistics. While sponsors have doubled the number of countries and increased the number of sites by 63% during the study period, the number of patients enrolled in a trial declined 18%. This is likely due to increasingly specific eligibility criteria raising rates of screen fail: from 1999 to 2002, 52% of patients who screened completed a trial, but by 2006, that number dropped to 28%.

At Antidote, we see this bearing out in our patient recruitment daily. Patients who want to take part in a trial find themselves ineligible, or unaware of their lab values, or unable to understand the study’s complex requirements. We’re constantly adjusting our approach in order to connect these patients with research. For example, trials are increasingly requiring specific lab values, so we have partnered with labs to connect patients with phlebotomists. This is just one piece of a larger puzzle we call precision recruitment.