Challenges and Opportunities for Pharmacists in Clinical Research

FDA approvals for drugs, devices, and biologics have remained relatively steady for the past decade, explained Jennifer Espiritu, PharmD, BCOP, CCRP, clinical research pharmacy specialist, Dana-Farber Cancer Institute, during a presentation at the Hematology/Oncology Pharmacy Association (HOPA) Annual Conference 2024 in Tampa, Florida. However, Espiritu noted that when the number of FDA-approved therapies is compared to the amount of open clinical trials, a pattern emerges.

“The number of clinical trials has more than quadrupled in this amount of time, while the number of approvals has remained steady,” said Espiritu during the HOPA session. “There are many reasons why this might be happening, including advances in technology that allow us to identify potential drug targets faster, as well as drug label expansions, and using drugs in different settings.”

However, as the number of clinical trials increases, so does the number of resources needed to conduct them, explained Espiritu. This includes an additional need for resources from institutions that are enrolling and treating patients.

“To illustrate the tremendous effort that goes into a clinical trial, Tufts University conducted a study looking at the complexity of the different clinical trial protocols. They found that the average phase 3 clinical trial collects 3.6 million data points. That's 3.6 million data points for one clinical trial. And this number has tripled over the past decade,” Espiritu said during the session. “When you consider all the kinds of information that can be collected, multiply it by the amount of patients that are enrolled on a clinical trial, and then further multiply it by the time the patients come in for these assessments, it's easy to see how 3.6 million starts to add up.”

Furthermore, as the number of clinical trials increases and they become more complex, clinical research teams have become more strained, according to Espiritu. As a result, there has been a workforce crisis that has developed within institutions.

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“This has become a real threat to successful clinical trial completion and, consequently, therapeutic innovation,” Espiritu said during the session. “At the heart of the problem is the fact that the clinical research workforce suffers from a lack of professional identity. Aside from physicians, other research professionals are often overlooked as key stakeholders in the research ecosystem. This is reflected in the fact that clinical research professional is not a recognized profession by the US Bureau of Labor Statistics.”

This crisis is then further exacerbated by a scarcity of qualified personnel. Espiritu explained that for every 1 experienced clinical research coordinator, there are 7 jobs available. Additionally, for every 1 clinical research nurse, there are 10 jobs available, and for every 1 regulatory affairs professional, there are 35 jobs available.

“This lack of sufficient workforce has been traced back to minimal intentional pursuit,” Espiritu said during the session. “Most professionals working in clinical research have found their way there by accident—including myself.”

Espiritu noted that the clinical research professional pathway is also rarely discussed as a career path in undergraduate programs for nursing and related health sciences. Additionally, what has worsened the supply issue for institutions are issues around skillset requirements in relation to salary discrepancies.

“Clinical research professionals require significant intellectual abilities and skills, but most institution-based staff are leaving to pursue roles in contract research organizations or pharmaceutical companies that offer better pay, benefits, and work-life balance,” Espiritu said during the session. “The academic skillset and salary discrepancy has been described as champagne tastes on a beer budget, which is an accurate analogy for what's going on at most academic medical centers.”

Additionally, the COVID-19 pandemic pushed health care to its limits, and the great health care resignation started, explained Espiritu. High turnover rates further increased the pressure on the remaining staff, which contributed to increased stress and burnout, further perpetuating the attrition cycle.

“Ever increasing trial complexity also contributes to the stress, burnout, and attrition of staff. The more complicated the trial, the more data points they're likely going to require you collect. The more data points there are, the more likely you're going to miss some, and you'll have to file deviations with either the sponsor or your local internal review board,” Espiritu said during the session. “But what if pharmacist practitioners can be incorporated into the clinical team to help alleviate the strain.”

There are certain clinical areas where pharmacists’ skills are particularly valuable when applied to clinical research, according to Espiritu. For example, pharmacists can support critical areas such as patient counseling, medication adherence, and reviewing patients for trial eligibility.

“Most clinical trials have a minimum or maximum amount of lines of therapy a patient has to receive before enrolling. While physicians are no doubt experts in this, the reality is that staff that are doing the preliminary detailed eligibility review are not physicians,” Espiritu said. “For example, in our institution, we have a nurse navigator that actually helps evaluate patients against eligibility. [For these professionals,] prior line requirements can be confusing when clinical trials have different rules as to what counts as one line of therapy.”

For example, Espiritu explained that some trials may not count adjuvant chemotherapy as a line, and so may not count maintenance therapies. Such terms are familiar to pharmacists, but may not be to other researchers that may be quickly skimming a chart, according to Espiritu.

“Most clinical trials will also have a predetermined amount of time that needs to pass from a patient's last dose of chemotherapy to starting treatment. These washout periods are typically defined in definitive timeframes, like 4 weeks from the last chemotherapy, or it can be based on the half-life of the previous chemotherapy given, whichever one ends up being shorter,” Espiritu said during the session. “Instances where a patient’s last therapy has a short half-life, pharmacists can actually identify that it's shorter than the predetermined 4 weeks, for example, and the patient can actually begin treatment a lot sooner.”

REFERENCE

Espiritu J. Collaborative Practice in Clinical Trials: Reinforcements for the Crisis in Clinical Research. Presented at: Hematology/Oncology Pharmacy Association Annual Conference 2024; Tampa, Florida; April 3-6, 2024.