Moving the Needle: How the Practice of Pharmacy Addresses Key Issues in Clinical Research
By Brittany Wade
September 6, 2022 | Pharmacists demonstrate tremendous expertise in drug counseling and dispensation, so it seems undeniable that they should play a prominent role in clinical research. After all, clinical trials are designed to establish the safety and efficacy of drugs: a pharmacist’s specialty.
However, pharmacists are rarely consulted in clinical trials. To remedy this issue, Founder and CEO Gerald Finken created RxE2, a community-based decentralized trial technology company spearheaded by pharmacists, offering primary stakeholders their rightful seat at the clinical research table.
According to Finken, the chasm between pharmacy and clinical research widened in the mid-’80s when the American Pharmaceutical Association bifurcated into the American Pharmacists Association and The American Association of Pharmaceutical Scientists.
“I sometimes think that’s the catalyst that separated it—why pharmacists don’t have a role in the industry today. Pharmacists went the way of community, and the formulation scientists went hardcore science into development,” Finken tells Deborah Borfitz, Clinical Research News senior writer and host of the Scope of Things podcast. As a result, each sub-specialty moved into more clearly defined and independent roles, slowly and surely leaving clinical research behind.
Today, RxE2 exists in the digital health space to integrate pharmacy practice into every aspect of clinical trials. Finken argues that a coordinated approach—where pharmacists, pharmaceutical scientists, and clinical staff collaborate on the patient’s behalf—would profoundly benefit the industry.
He says, “Forty years ago, it cost half a billion dollars to get a drug approved; seven to 14 years, nine out of 10 drugs failed. Fast forward to where we are today, it costs three billion dollars, seven to 14 years to get a drug approved, and nine out of 10 drugs fail. Let’s really take a look at this and step back and say, ‘How can we improve this?’”
Pharmacists improve clinical research by saving time, reducing costs, and increasing trial quality. They are trained extensively in drug counseling, asking open-ended questions and digging deeper to extract more information. This training allows independent pharmacists to establish trust, build rapport, and collect unique data points for clinical trials.
“I firmly believe that if pharmacists were involved, some of the issues that we’re having today in clinical trials wouldn’t exist. I don’t think recruitment would be a problem. I don’t think adherence and compliance would be a problem because pharmacists are medication experts trained to counsel patients and find out things in real-time,” adds Finken.
The practice of pharmacy also extends far beyond the drug counter as pharmacists troubleshoot issues with wearable devices, secure discounts for more affordable medications, and track down resources for patients in need.
Independent pharmacists see RxE2 as a valuable resource that increases patients’ access to necessary medical care. The startup also provides an additional income stream in exchange for pharmacists’ cognitive services, making the platform beneficial for nearly everyone involved.
Changing the Tide of Clinical Research
The industry is slowly warming up to the idea of pharmacists infiltrating the clinical trial space. Big box stores like Walgreens and CVS are taking more interest in clinical research and seeking to increase their presence in the sector. However, RxE2’s model differs significantly from pharmacy-driven retail giants because they aim to represent approximately 19,600 independent community stores across the United States, which accounts for roughly half of the industry.
While the company is more than capable of offering counseling and operational services to clinical research and biotech industries, patient recruitment and dispensation are the primary focuses for now.
The platform accesses pharmacy data from independent stores and, through an algorithm, compiles a list of potential patients that match specific clinical trial parameters. The pharmacist takes the first pass, culling patients with the highest potential to qualify for a trial. Then, they conduct an inclusion/exclusion call that narrows the list to only a handful of the most highly qualified patients.
This process reduced recruitment times from 18 months to eight weeks, and RxE2 was credited as the first to get pharmacist-referred patients into clinical trials successfully.
Finken and his team now work with 600 independent pharmacies, and 4,000 are currently in contracts. As the company grows, it hopes to develop a new and proprietary electronic records system that further streamlines the process. Pharmacy is a fast-paced industry, and the team acknowledges the need for straightforward and concise tools that provide the best care in the shortest amount of time.
“We’ve got to keep the attention of the pharmacist for two minutes. We have to fit our technology into their daily routines, which is in two-minute increments,” he says.
Aside from providing shorter recruitment times with more qualified patients, pharmacists also prove their value in decentralized clinical trials, where pharmaceutical drugs are often shipped across state lines directly to patients’ doors. In many states, clinical staff members are prohibited from dispensing medicines without a license in pharmacy. By partnering with select pharmacists in key states, dispensation in decentralized trials ceases to be an issue.
Furthermore, independent community stores serve as clinical research hubs where testing and medication management sessions are conducted locally, allowing doctors and other clinical research staff to continue their trials remotely.
Moving forward, Finken hopes to increase the understanding of pharmacists’ varied roles in clinical research and continue moving the needle in patient recruitment and retention. The industry may not always welcome change, but innovative companies like RxE2 encourage the adoption of new and efficient models for improved outcomes and exceptional patient care.