The Future of Clinical Trial Subject Enrollment (Part II): Pharmacies

With increasing challenges surrounding clinical trial subject enrollment and engagement, the landscape of clinical trials continues to morph. I recently blogged about how pharmacies will transform clinical research and the benefits that pharmacies offer, which include scalability, cost savings, quality, consistency, and enhanced subject enrollment outcomes.  This blog discusses how sponsors, CROs and study sites can leverage pharmacies to efficiently target, access and engage patients in clinical trial subject enrollment.

Analytically Optimized & Targeted Campaigns

The benefits of leveraging pharmacies for clinical trial subject enrollment includes the notion that study teams can access a vast array of patient data through pharmacy databases, and implement targeted clinical trial campaigns. To demonstrate, study teams who are interested in accessing a specific patient population (could be rare disease or broader diseases) can conduct analytical assessments on pharmacy prescription sales data to identify patient populations through geo-demographic analyses, including location, age, race, gender and more.  Study teams can, correspondingly, identify specific pharmacies and patient populations, and design highly targeted campaigns that maximize campaign ROI.  Naturally, study teams must consider compliance, when designing and implementing subject enrollment campaigns, and need to conduct statistically valid assessments on patient data in order to optimize campaign targeting and design.

Another benefit of accessing pharmacy databases includes the fact that biopharmaceutical sponsors can optimize site selection strategies by understanding where patient populations exist, leading to catalyzed enrollment outcomes through optimized site selection strategies.

Though many would argue that pharmacy databases contain Protected Health Information (PHI) via HIPAA regulations, and that such data is inaccessible by third parties, there are enterprises are offer de-identified patient data that is in line with the US Department of Health’s guidance on de-identified PHI [1].

Trusted Environment

Research has shown that pharmacies are an excellent medium to engage patients because pharmacies offer a trusted environment for patients to learn more about clinical trials.  To elaborate, over 80% of patients would like to hear about clinical trials from their pharmacist, and over 72% of patients are interested in receiving information about clinical trials from their pharmacist [2].

Humanization is also an important aspect in clinical trial subject enrollment, as many patients trust healthcare professionals with healthcare related matters. To demonstrate, patients are more likely to respond and act if they heard information about clinical trials from a trusted person than a TV advertisement.  It is important to keep this point in mind when designing pharmacy campaigns; are you going to engage patients by requesting pharmacists to drop fliers in the patient’s medication bag? Are you planning to design tabletop banners to be displayed in pharmacies? Or design pharmacist training programs to discuss clinical trials with patients?  It is essential to consider the targeted patient population and campaign compliance when executing pharmacy campaigns.

Study Site Patient Volume Management

One of the many challenges that study sites experience with clinical trial subject enrollment is effectively finding the right prospective patients, and efficiently processing them into the right clinical trial.  A major benefit that pharmacies offer is high patient volumes; according to research, pharmacy patient volumes are over 5 times that of primary and specialty care physicians [3].  In order to maximize the effectiveness of subject enrollment campaigns on a broader level (i.e., positioning as a medical/clinical research center), study sites must develop internal and external business enrollment infrastructures in order to efficiently process high patient volumes.

What Kind of Pharmacy Should We Access?

It depends on the protocol and targeted patient population.  A biopharmaceutical sponsor specializing in a rare disease may want to access specialty pharmacies, as such pharmacies have a tendency to develop patient communities which helps with reach and relationship building for post-approval purposes.  For larger and broader clinical trials, large pharmacy chains would be a better option due to scalability and global reach. For study sites, engaging local and retail pharmacies around the site are good methods for attracting patients. Correspondingly, developing solid business strategies for tailored to unique situations tend to work best.  It is imperative that any subject enrollment campaign undergo compliance review. Which option is best for your clinical trial/organization?

Moe Alsumidaie is the President & Chief Scientific Officer of Annex Clinical, and can be reached here.

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References:

[1] http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/De-identification/guidance.html#coveredentities

[2] Diane Simmons, Jill Chapped, Kenneth A. Getz et. Al. Are Pharmacists a Viable Channel for Education about Clinical Trial Participation?, Drug Information Journal, 2011 45:443

[3] Getz, Kenneth. Impact of In-Pharmacy Education on Patients’ Knowledge and Attitudes about Clinical Trials.  Tufts University School of Medicine, January 2013

[4] http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=824972&sk=00c6557c5723cbf21d4b22c831c5ccfb#!