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.
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 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.