Kenneth Getz of the Tufts Center for the Study of Drug Development looks at leveraging pharmacists as a channel to raise clinical research literacy among patient communities.
Patient recruitment and retention are among the greatest challenges facing the clinical research enterprise today and are a major cause of drug development delays. New research from the Tufts Center for the Study of Drug Development (CSDD) found that while nine out of 10 clinical trials worldwide met their patient enrollment goals, drug developers typically had to nearly double their original timelines to achieve the targeted numbers.
A formidable obstacle to timely and effective patient recruitment is the public’s lack of knowledge about the clinical research process, particularly since improvement in knowledge is associated with greater willingness to participate in trials. One National Institutes of Health study of more than 1,000 U.S. adults found that only one in three had even heard of clinical trials.
Despite the high costs of drug delays, the pharmaceutical industry has not been particularly proactive in its efforts to bridge this awareness gap. Nor has it been particularly innovative in its patient recruitment methods. According to the new Tufts CSDD study, most drugs sponsors and contract research organizations rely on a limited number of traditional recruitment and retention tactics, such as physician referrals and newspaper, television, and radio ads, and have yet to embrace non-traditional approaches.
A case in point is the fact that the industry has largely ignored the more than 60,000 pharmacies in the U.S. as a potential channel to educate and engage the public about clinical research. The Center for Information and Study on Clinical Research Participation (CISCRP) has now conducted two studies to examine the feasibility of pharmacy-directed outreach and education. Our findings indicate that our industry has an opportunity to leverage pharmacists as an untapped, trusted source to deliver clinical research education, raise public awareness and facilitate timely patient recruitment.
Educational Channels Offering Trust and Accessibility
The vast majority of the general public is unfamiliar with and wary about clinical research. CISCRP research has found that fewer than one in 20 Americans know where to find information about relevant clinical trials. Moreover, the role of mistrust as a barrier to clinical trial participation has been widely reported in the literature. In a 2012 Harris poll, only 12% of Americans indicated that pharmaceutical companies are “generally honest and trustworthy.”
Conversely, major international opinion polls indicate that pharmacists are one of the most trusted sources for health-related information. In Gallup’s 2011 Honesty and Ethics survey covering 21 professions, pharmacists ranked second only to nurses and ahead of physicians – the ninth consecutive year they ranked in the top three.
Pharmacists are also the most accessible health information providers in the country. Americans visit pharmacies at more than five times the annual rate at which they visit their primary and specialty care physicians combined. These pharmacist-patient interactions are likely to increase as pharmacists become more involved in patient care, including their expanded roles in managing medication therapies and chronic diseases.
Feasibility and Viability of Pharmacists as Educators
Since pharmacists are highly trusted and have plentiful opportunities for patient interactions, CISCRP conducted research to examine whether they might be an effective channel to educate and engage the public about clinical research. Our first study in 2010 focused on potential public receptivity to receiving information on clinical research from pharmacists. Its notable findings included:
· Nearly 80% of the 2,650 respondents would like their pharmacists to tell them about clinical trials, yet only 1% reported receiving this information from their pharmacists.
· While all demographic groups were open to receiving pharmacy-directed clinical research educational materials, respondents who had closer relationships with their pharmacist were the most receptive.
· Respondents were most interested in information about how to find clinical trials, whether they are safe, and how to learn more about them.
Our follow-up study in 2012 evaluated the impact of in-pharmacy education on patient’s knowledge, interest and willingness to participate in clinical trials. CISCRP collaborated with McKesson to engage and train pharmacists at 32 locations within its national network of independent community pharmacies. CISCRP provided each pharmacy with educational materials to display and/or distribute for a period of 2-3 months. Pre- and post-surveys among 487 patients were conducted to gather baseline measures and to assess the impact of educational materials and in-pharmacy discussions.
The results indicated that outreach through the pharmacy educational channel markedly improved patients’ knowledge of and interest in participating in clinical trials. Here a few highlights:
· Nearly all baseline measures of awareness and comprehension increased by 10 to 20 percentage points including patient confidence in their knowledge about clinical research and in their understanding of the benefits and risks of participation.
· Six out of ten respondents in the post-test also reported that they would be more likely – ‘very’ and ‘somewhat’ – to recommend clinical trial participation to a friend or family member.
· Although the study objective was to measure receptivity and changes in comprehension, not behavioral changes, we were surprised to find that nearly 6 of the post-survey respondents (4% of the total) enrolled in clinical studies during the limited timeframe of the study.
The study also corroborated other research regarding pharmacists’ accessibility and trustworthiness. More than 30% of patients reported visiting their pharmacies six or more times during the period when the educational materials were on display. And 15% indicated that they had spoken to the pharmacist or pharmacy staff about clinical trials.
This research suggests that pharmacies represent a compelling new patient outreach and education opportunity. Moreover, given their accessibility and closeness to patients, pharmacists may play a valuable role in disseminating information supporting sponsor and CRO patient recruitment strategies. Specifically, pharmacists may add value to targeting prospective study volunteers by vetting and validating pre-qualified candidates based on the pharmacists personal knowledge of patients and their health care options.
Community pharmacists also provide a potential channel for difficult-to-reach individuals in remote areas, a largely untapped target demographic. These potential trial participants generally visit their pharmacies much more often than their city and suburban counterparts, which affords study sponsors more opportunities for education and engagement. Many of the pharmacists in our second study were located in relatively remote areas; one commented that “This was a new experience for patients living in our small town. Usually only large cities or large hospitals have access to this kind of information.”
The clinical research enterprise has a critical and growing need to engage the public and patients in discourse as to the nature, safety, and importance of clinical research in advancing medical knowledge about disease and how to treat it. As our study results demonstrate, pharmacists are an important new channel for increasing clinical research literacy among patient communities and for raising patient awareness about opportunities to participate in clinical trials.
About the Author
Kenneth Getz is Founder and Chairman, CISCRP, and Director, Sponsored Research Programs, Tufts CSDD.