Pharmacy-Based Clinical Trial Recruitment: A Potential New Role for the Pharmacist?

Research presented on June 25, 2013, at the Drug Information Association (DIA) 2013 49th Annual Meeting could trigger a paradigm shift in clinical trial patient recruitment and could change the way pharmacists engage with patients as new drugs make their way through the FDA approval process.

More than 66% of patients who take part in clinical drug trials are referred into the trials by physicians, according to data from a 2010 Tufts Center for the Study of Drug Development (CSDD) analysis. But 85% of the same patients report that they get information about medications from their pharmacist, so aren’t pharmacists best-positioned to inform patients about new drugs being tested in clinical trials?

According to Kenneth Getz, MBA, director of sponsored research programs at CSDD and founder and board chair of the Center for Information and Study on Clinical Research Participation (CISCRP), recruiting the right kind of patients into clinical trials is very challenging. Some of these issues stem from poor study design, but other recruitment barriers are directly linked to problems with patients.

Recruitment headaches can stem from low patient awareness of drugs in development and trials that are in process, as well as a deep distrust among some potential participants of pharmaceutical companies and their motives for conducting such trials. Other patients may be more amenable to enrolling in trials, but may have concerns regarding the safety and efficacy of drugs that have not been fully approved by the FDA.

For others, it is simply a geographical problem. “Half of the American public can’t name where clinical studies physically occur,” said Getz during a presentation at the DIA 2013 49th Annual Meeting, adding that there is generally little-to-no follow-up after the trials conclude, leaving patients in the dark about the value of their participation. “Ninety percent of patients in clinical trials never learn the results of their own study,” Getz said.

Although physicians are considered one of the most trusted sources for medical and clinical research information, less than half of physicians refer a patient into clinical trials each year, and Getz points out that this leads to an average referral rate of less than 1% of all patients. Meanwhile, pharmacists are ranked above physicians in terms of their perceived honesty and integrity, as a recent Gallup poll revealed, but only 2% of patients surveyed in 2011 by CISCRP ranked pharmacists as the top source for information about clinical research.

In order to investigate the effectiveness of pharmacists as clinical trial recruiters, Getz conducted an experiment in 32 independent community pharmacies in late 2012. His team set up displays in the pharmacies about clinical trial enrollment for a period of 2 to 3 months, and CISCRP trained a pharmacist in each of the 32 participating pharmacies. The researchers asked 792 pharmacy patients to complete pre-test questionnaires. Of these subjects, 162 also completed an online or phone-based post-test summarizing their attitudes about clinical trials.

After patients learned from pharmacists how their participation in clinical trials could help them gain access to new medical treatments free of charge and allow them to play an integral role in the collection of medical data, interest in trial participation increased.

“The results of the study show that patient discussions with their pharmacists and patient review of educational materials distributed through pharmacies positively impacted patient awareness, comprehension, and willingness to participate in clinical trials,” the authors concluded. After implementation of the in-pharmacy education efforts, 6 of 10 patients said in the post-test that they would be more likely to recommend clinical trial enrollment to family and friends.

When asked whether they had ever asked a pharmacist about clinical trials, only 2% of respondents said they had, leading the researchers to conclude that without in-pharmacy education, the public would be unlikely to make such inquiries of pharmacists.

The survey results also revealed that 80% of respondents said they would want a pharmacist to tell them about clinical trials for their condition. This patient willingness to learn from their pharmacists, coupled with the fact that patients visit American pharmacies 5 times more frequently than they do physicians’ offices, led the researchers to conclude that pharmacies are a “viable and untapped patient education channel” that ought to be used more aggressively.

In a separate web-based observational study, Carrie Hurwitz, MBA, McKesson StudyLink's director of corporate strategy and business development, used the above-described in-pharmacy recruitment methods to refer 221 patients into a trial for treatment with triptans for migraines. McKesson used a tool called StudyLink and pharmacy claims data to prescreen potential trial candidates. Of the 221 patients referred, 161 patients enrolled in the trial, representing a 73% conversion rate.