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Ken Getz of the Tufts University Center for the Study of Drug Development (CSDD) explains how building a stakeholder outreach agenda around the community pharmacist can lead to a better outcome in managing the complex ins and outs of a trial protocol.
Patients today are a hard to reach segment of the healthcare marketplace, a trend which is having a particularly pronounced impact on finding the most suitable candidates for participation in clinical trials. Delays in identification and recruitment of patient candidates are on the upswing, which is a losing money at the bank proposition for an industry structured around the long cycle times—now around 13.6 years—for moving a new medicine forward, from proof of concept to commercial launch. In the following feature, Ken Getz of the Tufts University Center for the Study of Drug Development (CSDD) explains how building a stakeholder outreach agenda around the community pharmacist can lead to a better outcome in managing the complex ins and outs of a trial protocol. —William Looney, Editor-in-Chief
Patient recruitment and retention are among the greatest challenges facing the clinical research enterprise today. This increasingly complex and burdensome task is a major cause of drug development delays, which has in turn put far more focus on making trial management a strategic priority for Big Pharma. New research from the Tufts 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. And in the drug development process, time is money.
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 US adults found that only one in three had even heard of clinical trials. Investment in education is therefore a must, and is adding to the list of activities that companies must initiate to improve the external environment in which trials are conducted.
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. There is little progress in leveraging new platforms and technologies that facilitate non-traditional approaches to engaging with clinicians and patients.
A case in point is the fact that the industry has largely ignored the more than 60,000 pharmacies in the United States as a potential channel to educate and persuade 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 the 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.
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 percent 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. In many European countries, like Germany, community pharmacists rank at the very top of the trust and credibility chain, carrying a reputation as honest brokers between the drug industry, health providers, and the patient.
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 direct patient care, including their expanded roles in managing medication therapies, adherence programs, and the incidence of chronic diseases.
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 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 percent of the 2,650 respondents would like their pharmacists to tell them about clinical trials, yet only 1 percent reported receiving this information from their pharmacists.
» While all demographic groups were open to receiving pharmacy-directed clinical research and 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 two to three 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 (see table).
Survey participants were asked: Which of these are possible benefits or risks of participating in clinical trails?
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 10 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 six of the post-survey respondents (4 percent 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 percent of patients reported visiting their pharmacies six or more times during the period when the educational materials were on display. And 15 percent indicated that they had spoken to the pharmacist or pharmacy staff about clinical trials. This has a carry-on effect, with this increased traffic being beneficial to the pharmacy bottom line.
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 healthcare options. It is a cost effective form of anticipatory screening.
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." This represents a trend in rural areas, where pharmacists are essentially surrogates for the scarce physician practice.
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. Hence, 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. It is another reason why trial recruitment and management has literally become everyone's business if new drugs are to be the result.
Ken Getz is founder and Chairman of the Center for the Information and Study on Clinical Research Participation, and Director, Sponsored Research, for the Tufts University Center for the Study of Drug Development in Boston. He can be reached at email@example.com.