By Deborah Borfitz 

January 27, 2022 | The role pharmacists play in the community is the same one they should be playing in clinical research, according to Gerald Finken, founder and CEO of RxE2 whose mission it is to help make that happen. His belief is that “community-based clinical trials” in general can be better for patient care, the pharmacy as a profession, and study sponsors who have long had trouble recruiting enough patients into their studies. 

Within the next decade, Finken predicts, pharmaceutical companies will no longer be running clinical trials that exclude pharmacy professionals because it will simply be too costly and overly risky. When shipping drugs directly to patients, as has become customary with decentralized clinical trials (DCTs), many state pharmacy laws specifically stipulate that they follow the practice of pharmacy—which includes patient counseling and patient-specific labeling. 

Finken will be offering remarks about the important role of pharmacists in clinical research as chairperson for a series of presentations on redefining their role in DCTs at the 2022 Summit for Clinical Ops Executives (SCOPE). The sessions will examine the use of specialty pharmacy expertise to enhance the patient experience and streamline supply delivery, deployment of digital direct-to-patient solutions, pharmacy laws governing clinical trials, and Medidata’s platform for managing direct-to-patient shipping. 

RxE2 intends to partner with multiple established technology providers, including Medidata and DCT specialists Science 37 and Medable, to enable clinical trials not only in patients’ home but wherever participants find it most convenient, says Finken. That may well be their local pharmacy, including one of the roughly 22,000 independent community stores that RxE2 is targeting for collaboration.

More than 4,000 independent pharmacies are already on the RxE2 platform signaling their interest in being involved in clinical trials, Finken says. CVS (with about 10,000 stores) only last year announced the launch of its Clinical Trial Services business and Walgreens (with about 9,000 stores) will be following suit. “It’s going to be CVS, Walgreens, and us.”

The decision by CVS to move into the clinical trials space was a welcome one, says Finken, because it removed the “huge hurdle” in getting pharmaceutical companies to see the wisdom in the approach.  Supermarket chains with pharmacies, including Kroger and ShopRite, don’t have to take on the market leaders on their own but can instead get on the RxE2 bandwagon.

“We already have the platforms for pharmacists to work from, and we already know how to get in the [pharmacy] database to identify patients for clinical trials based on the medications they take,” he notes. “It’s a brand-new world out there and we’re on the cutting edge of it.”

Revenue Source

Independent community pharmacies are better set up to run clinical trials than the big chains, in part because they typically offer residency programs whose students can assist in conducting studies, says Finken. A busy CVS pharmacist filling 400 scripts a day might instead need to hire another pharmacist to handle the added workload.

Community pharmacists are also constantly looking for new revenue sources, he adds. As will be discussed at SCOPE by Jeremy Faulks, PharmD, vice president of strategic initiatives for Thrifty White Pharmacy, the first-ever annual recurring revenue (ARR) pricing model for clinical supplies has launched and, Finken predicts, it will “revolutionize” thinking about the dispensing of medication through pharmacists. ARR “greatly simplifies the entire budgeting, contracting, and invoicing process for clinical supplies,” he notes.

The new model involves the dispensing of specialty products and patient counseling for DCTs and, potentially, all clinical trials of the future where medications are variably shipped directly to patients or picked up by them from a clinic, pharmacy, school, or other convenient, community-based site, says Finken. 

Clinical trials are currently done primarily at academic institutions and dedicated research centers and, to a modest but growing degree, in patients’ homes, continues Finken. But RxE2 wants to incorporate the practice of pharmacy to make research participation an option for “everyone, everywhere”—including people who may be uncomfortable with a DCT where nurses they don’t know are coming into their home.

It is odd that the pharmaceutical industry ever excluded pharmacists in the research process to begin with, he adds. “It has always been doctors, nurses, and patients, but in the commercial setting in the real world, it’s doctors, pharmacists, and patients.” 

The COVID-19 pandemic has served to exemplify pharmacists’ role in providing the “best healthcare possible,” says Finken. “Very few people talk about going to the doctor to get vaccinated. Almost everybody goes to their pharmacy.”

Finding Patients

For the past four decades, study sponsors have overlooked an entire population of patients who go to their local pharmacy to retrieve prescription medications and where a database of those filled scripts resides, Finken says. RxE2 wants to start funneling some of those patients into trials and help solve the patient recruitment dilemma.   

RxE2s has a technology platform to optimize and connect those pharmacies with current clinical sites, and eventually clinical studies it will be doing within those pharmacies, on behalf of sponsor companies, he explains. Additionally, it will help pharmacists identify patients for trials and keep them engaged, adherent, and compliant.

“We have [machine learning] algorithms and predictive tools that help pharmacists identify patients who are starting to have difficulty in a trial… and working with pharmacists themselves to optimize their efforts,” says Finken. RxE2 essentially works “behind the scenes” on the transactional, operational aspects of a trial so pharmacists can “[work] at the top of their profession by talking to the patient and finding out additional things that you can’t learn from the data.”

Among the tasks assumed by RxE2 are to download prescription information on pharmacy patients and then apply its algorithms and search engines to identify those potentially eligible for a clinical trial, he says. “Out of the 50 we identify, we [narrow the list to] the 10 best and then ask the pharmacist to call those patients.”

Another key differentiator of RxE2 is that it will also be collecting subjective data from pharmacists and entering it in a database to build an “electronic pharmacy record” inclusive of both prescription and behavioral data from the ground up, Finken continues. Other companies, meanwhile, are still grappling with the monumental task of how to pull health information out of old, traditional electronic health records. 

“The best part of this is that the revenue comes entirely from [sponsor companies],” says Finken. “We pay the pharmacies fair market value for their [top-of-license] services.” 

The revenue stream could be what allows them to continue in their pharmacy practice, he adds. “[Their] dispensing of medication is going to be a thing of the past because machines can do it so much better and faster.” 

Pharmacy Laws 

By law in most places, when medications are dispensed to patients, they need to be counseled to ensure they are safely and effectively using those drugs. Pharmacists do this as a matter of routine, which in a clinical trial context can translate into better adherence and compliance, says Finken. 

As will be shared at SCOPE by Kimberly B. Moore, clinical pharmacist at GLO & Associates, 28 states outline the requirements for dispensing a drug and continued individual state regulation monitoring is necessary to support successful clinical trials, especially decentralized trials. It is simply in following these laws that pharmacists are going to get involved in clinical trials, Finken points out. 

Of perhaps even greater importance is that DCTs, in shipping drugs directly to patients, must follow state pharmacy laws that include having the patients’ name, instructions for use, and expiration date on the label, he adds. “For the first time ever, we are going to have patient-specific labeling when it comes to clinical supplies.”

In a separate SCOPE talk by Smit Patel, director of digital medicine for the Digital Medicine Society, the focus will be on the role of pharmacists in providing patient support and counseling in the use of digital devices such as glucose monitors and other wearables rather than prescribed pills and injectables. If the devices are approved by the U.S. Food and Drug Administration, Finken says, certain legal requirements also apply here.