LATE-BREAKING RESEARCH: PRACTICE MANAGEMENT
Abstract #PM06

Integration of a Clinical Pharmacist in a Phase 1 Clinical Trial Program

JHOP - March 2021 Vol 11 Special Feature - HOPA Abstracts, Clinical Trials

Presenter: Jennifer Espiritu, RPh, PharmD, BCOP, Clinical Research Pharmacy Specialist, Dana-Farber Cancer Institute

Co-Authors: Jiale Dai, Department of Pharmacy, Dana-Farber Cancer Institute, Boston, MA; Caroline Harvey, Department of Pharmacy, Dana-Farber Cancer Institute, Boston, MA

Background: Enrollment into clinical trials has been endorsed by the National Comprehensive Cancer Network as acceptable, or even preferred, therapies in certain malignancies. Although clinical trials provide essential information about potential new therapies, implementation and operationalization can be challenging. Requirements that do not exist in the ordinary standard-of-care setting pose unique challenges that institutions must find a way to overcome.1,2 These challenges are especially prevalent in phase 1 clinical trials, because investigational agents are being studied in humans for the first time.

Objective: To evaluate the impact of a clinical pharmacist within a phase 1 clinical trial program at a National Cancer Institute–designated cancer center.

Methods: A full-time clinical pharmacist was integrated into the Early Drug Development Center at Dana-Farber Cancer Institute to assist with the conduct of phase 1 clinical trials. Pharmacy interventions from February 2020 through November 2020 were documented and analyzed to determine trends and the overall impact of the clinical pharmacist.

Results: A total of 446 interventions were recorded during the 9-month study period. Drug interaction screenings (N = 166; 37%) accounted for the majority of the interventions and were performed for potential and for existing patients in clinical trials. A comprehensive medication list review was performed as part of protocol screening procedures for 102 prospective patients. During these reviews, 38 prohibited and 104 cautionary medications (ie, allowed per protocol but could influence the metabolism of the investigational agent and/or concomitant medication) were identified. Newly prescribed medications for 64 patients already receiving investigational medications were also reviewed; 10 prohibited and 18 cautionary medications were found. Other pertinent interventions included coordination of care activities (N = 79; 18%), inventory management (N = 82; 18%), drug information (N = 63; 14%), and order entry support (N = 56; 13%).

Conclusion: Clinical pharmacists have the potential to assume an integral part in conducting oncology clinical trials. The most notable area for pharmacist involvement is drug interaction detection. Most investigational agents undergoing phase 1 clinical trials lack formal in vivo drug interaction data, and in vitro drug interactions are frequently extrapolated. Thus, warnings surrounding drug interactions are typically described in terms of effects on the CYP450 system and other transporters, which pharmacists are well versed in. Clinical pharmacists are also in a prime position to disseminate information about intricate treatment plans and any deviations from them to appropriate ancillary staff, which can tremendously improve the patient experience. Clinical pharmacists are an untapped resource that can elevate clinical trial conduct within an institution.

  1. Zon R, Meropol NJ, Catalano RB, Schilsky RL. American Society of Clinical Oncology statement on minimum standards and exemplary attributes of clinical trial sites. J Clin Oncol. 2008;26:2562-2567.
  2. Amin SR, Lee JS, Avila JG, et al. HOPA Investigational Drug Service Best Practice Standards. Hematology/Oncology Pharmacy Association; 2018.
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