In the final installment of ACCC’s webinar series honoring American Pharmacists Month, experts discussed the integral role pharmacists play in supporting clinical trial research in the community setting, and they identified opportunities for extending the pharmacist role in an increasingly complex research landscape. 

The webinar was moderated by Sandeep Parsad, PharmD, MBA, BCOP, assistant director of pharmacy at the University of Chicago Medicine. She was joined by Sapna R. Amin, PharmD, BCOP, manager of investigational pharmacy services in the Division of Pharmacy at MD Anderson Cancer Center; Cindy L. O'Bryant, PharmD, BCOP, FCCP, FHOPA, professor at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences; and Siu Fun Wong, PharmD, chair of the SWOG Pharmaceutical Science Committee. 

The Pharmacist in Community Research  

Community-based cancer programs enable clinical trials to have a broader reach beyond traditional settings and provide greater access to breakthrough treatments for patients with cancer. Unique challenges apply to offering clinical trials in this setting. With those challenges, however, come opportunities for the pharmacist to play an increasingly critical role. 

Pharmacy has an integral role in pre-site meetings and capability assessments when working with partners, sponsors, or researchers in making initial determinations about whether a cancer program and its pharmacy can meet the needs of the study, such as whether it has adequate staffing, space, or other operational resources.  

The timeline of a study can span from one month to five years, and pharmacy has a crucial role to play in the initiation, set-up, maintenance, and close-out of the study. Pharmacists are responsible for drug accountability and record-keeping for the lifespan of the clinical trial. 

“It’s important to understand the oversight of that trial and how that will be done in your practice setting,” advised Dr. Amin. “It’s crucial that policies and procedures are in place in order to be successful.” 

“Not only is a pharmacy responsible for answering to what pharmacy does within its institution, the pharmacy is also responsible for answering to the regulatory bodies and authorities as it is audited as part of the clinical study,” Dr. Amin added. “Once it goes to marketing part of the drug, all of this information is supplied to the FDA, and the pharmacy is a key part of those audits.” 

Pharmacy and the Cost of Clinical Trials 

The goal of clinical trials is to develop safe and effective strategies to prevent, detect, diagnose, treat, and cure cancer and to evaluate the efficacy and safety of new drugs and other cancer-related 

technologies. To reach those goals, adequate funding is necessary. “Pharmacists are notorious for giving away services, and we really have to think about how we want to bill, to fund a research program to provide these things,” said Dr. O’Bryant. 

When budgeting for clinical trials, there are several cost areas to itemize, including: 

• Indirect costs (i.e., operational costs) 

• Study start-up costs (i.e., extra procedures within the infusion center or assays that will need to be introduced) 

• Regulatory costs that would be involved in the start-up, maintenance, and closure phases of the study 

• Per-patient costs, including labs, tests, procedures, PK/genomic sampling, study coordination, and salary support.

Extending the Role of the Pharmacist

Pharmacists at the University of Colorado provide medication therapy management for research protocols, including drug interaction review at screening and during trials, dose modifications review, and patient education. They also are involved in direct patient care when conducting study-related visits such as toxicity assessment. 

Other non-traditional opportunities for research pharmacists include protocol development or review, study implementation, pharmacokinetic sampling and analysis, and translational research. Dr. O’Bryant recommends that pharmacists serve in research leadership roles such as committee chairs and directors or as principal investigators in industry-sponsored or investigator-initiated trials.  

Pharmacists can optimize their role in research by taking advantage of opportunities to educate others in their communities and in their workplaces about their unique knowledge, skills, and experiences, noted Dr. Wong. She also suggested that pharmacists determine the breadth and depth of the services they wish to engage in and create documentation to support the value of those services, such as an itemized budget. She also recommends using research that already exists to support the value that pharmacists bring to research. 

Perhaps most important is that any pharmacist seeking to optimize their role be ready to act on opportunities when they arise. As healthcare teams continue to shift workflows and strategies, the role of the pharmacist is likely to continue to grow increasingly important in the multidisciplinary cancer care team.