Applied Clinical Trials
Due to increasing costs and lacking productivity of the existing clinical trial operational model, there has been a lot of awareness around ?Future Clinical Trials,? and some sponsors are seeming to transform pharmacies into study sites.
Due to increasing costs and lacking productivity of the existing clinical trial operational model, there has been a lot of awareness around “Future Clinical Trials,” and some sponsors are seeming to transform pharmacies into study sites. Novartis, for instance, presented a pilot program on leveraging pharmacies for clinical trial conduct [1, 2].
Sponsor Benefits of Leveraging Pharmacies as Study Sites
Patient access in clinical trials is challenging, as many patients are unreachable. To demonstrate, 85% of cancer patients seek treatment at private oncology clinics, and only 50% of private oncology clinics conduct clinical trials . Knowing that over 67% of the US population lives within 3 miles of a Walgreens pharmacy , sponsors are able to access patients through a medium where patient volumes are over 5 times that of primary and specialty care physicians . I will speak about pharmacy subject enrollment and retention in a future blog post.
Scalability & Cost Savings
An exciting aspect of using pharmacies as study sites includes the fact that pharmacies offer scalable business operations to conduct clinical trials. For example, sponsors can establish drug distribution capabilities within the pharmacy supply chain process; not only can sponsors ensure that investigational product is going to be delivered through IT system triggers, but they can also rely on clinical supply chain regulation management and pre-established SOPs.
Quality and Consistency
Another benefit of leveraging pharmacies includes relying on quality and consistency in clinical trial conduct. To demonstrate, if pharmacies set up their retail stores as study sites, sponsors can cut down on the site feasibility process, as they can depend on consistency in SOPs, training programs, culture, and study personnel. Protocols and business processes, nonetheless, will need to be optimized for this business model.
Post Marketing Efficiency & Relationships
If a patient undergoes a clinical trial in the pharmacy setting, they tend to associate their pharmacy with the medical product. Sponsors can establish relationships with pharmacies during the R&D phase to the extent in which they can significantly improve the efficiency of the drug distribution process and patient access after a medical product has received NDA approval. It is important, nevertheless, to ensure that the sponsor is not violating federal regulations for unapproved medical product promotion during the R&D phase.
How will This Impact Study Sites?
Naturally, sponsors will be veered towards business operations that offer cost savings, consistency, quality, and enhancements in clinical trial productivity. For study sites, this could mean less business, as existing study site business models could not reach the levels of scalability that a large pharmacy chain can. If study sites cut their costs to compete with pharmacies, they cannot generate sufficient profitability to stay afloat.
What Should Study Sites Do to Prepare for the Future?
Build Subject Enrollment Infrastructures with Pharmacies
Study sites can leverage pharmacies to access and recruit patients in an optimized fashion. In this case, study sites will need to build subject enrollment infrastructures in order to rapidly process patients and get them in the right clinical trial. This involves business capabilities development and campaign management.
Expand Business Offerings
Study sites have databases with comprehensive patient medical records; pharmacies have bits and pieces of prescription and patient data. Study sites can leverage their IT systems through the use of Natural Language Processing/Machine Learning in order to screen study subjects in an optimized fashion.
Although pharmacy chains can offer the aforementioned benefits, most pharmacies do not offer specialty capabilities. To elaborate, study sites can differentiate themselves by specializing in specific disease ailments that require the involvement of highly trained staff, and specialized medical equipment.
By Moe Alsumidaie, President & Chief Scientific Officer,Annex Clinical. Moe Alsumidaie can be reached here. If you are interested in joining the discussion, apply to the Breakthrough Solutions in Clinical Trials & Healthcare Group.
 A Patient-Focused Solution for Enrolling Clinical Trials in Rare and Selective Cancer Indications: A Landscape of Haystacks and Needles. Eric B. Lynam, Jiin Leaw, and Matthew B. Wiener Drug Information Journal, July 2012; vol. 46: pp. 472-478, first published on April 18, 2012
 Getz, Kenneth. Impact of In-Pharmacy Education on Patients’ Knowledge and Attitudes about Clinical Trials. Tufts University School of Medicine, January 2013