Low health literacy leads to low patient enrollment

Clinical trials often have so many unique variables - site supply, risk-based monitoring and source document verifications to name a few - that it can be easy to forget that no investigation can move forward without the required number of human subjects. In fact, patient recruitment is one of the largest problems facing clinical research organizations today.

"Eighty percent of clinical trials fail to meet their enrollment goals," Nariman Nasser, director of participant recruitment at the University of California San Francisco's Clinical & Translational Science Institute, said in a statement. "The recruitment of research participants is critical to conducting clinical and translational research, and if we cannot recruit adequately, we simply cannot carry out successful clinical research."

What keeps patients from enrolling into clinical studies and what can recruitment managers do to increase participation rates? According to pharmaceutical giant Eli Lilly, low awareness rates contribute to attitudes among the patient population that stifle enrollment, though health literacy programs may be able to reverse this trend.

Breaking through to patients
Whether it is through informed consent forms or engagement strategies, many organizations choose to focus on health literacy efforts after patients have entered their systems. Clinical trials, though, need to enroll patients right at the outset.

However, regardless how strongly clinical researchers feel about their projects, this passion has not translated to patients. In fact, Eli Lilly estimated that only 16 percent of cancer patients are even aware that clinical trials exist with experimental cures for their conditions. Given uncertain conversion rates for prospective subjects, clinical trials that pull from only 16 percent of a potential patient base are already setting themselves up for failure.

Once informed, though, 43 percent of patients end up enrolling and participating in studies, which should encourage clinical trial locations with flagging patient participation numbers to rethink their health literacy outreach efforts.

Winning hearts and minds
Contract research organizations must effectively manage hundreds of small details within the much larger scope of a clinical trial, but all those points are moot if a location never enrolls enough patients to begin research. Therefore, the first step any successful clinical trial must take is ensuring a robust health literacy program targeted at prospective subjects.

With easy-to-read materials across various platforms written in language that patients understand, effective health literacy programs help CROs breeze through the perilous recruitment phase to speed up research timelines and, ultimately, reach data lock and market release as fast as possible.