Evaluation of Clinical Pharmacy Services for Phase 1 Clinical Trials.

BACKGROUND: Phase 1 clinical trials have challenges relative to later-phase clinical trials. As of April 2020, there were 71 active phase 1 cancer clinical trials at the Johns Hopkins Medicine Sidney Kimmel Comprehensive Cancer Center (SKCCC), and limited clinical pharmacy services are dedicated to the unique needs of phase 1 clinical trials. OBJECTIVES: To characterize the current phase 1 cancer-specific clinical pharmacy services at National Cancer Institute (NCI)-designated institutions, and to develop a framework for the implementation of these services at Johns Hopkins Medicine SKCCC. METHODS: We queried the current pharmacy practices for phase 1 cancer clinical trials at NCI-designated institutions through an e-mailed 20-question national online survey to 208 pharmacists. The recipients were asked to rate how often specific pharmacy services were performed, using a 4-point Likert scale of rarely/never (<10%), sometimes (10%-49%), often (50%-80%), or almost always (>80%). The services were grouped into pretrial implementation support, phase 1 trial implementation support, medication profile review, medication therapy management, and miscellaneous support. Using the survey results, a framework for phase 1 trial clinical pharmacy services was developed concurrently to prioritize protocol complexity, monitoring requirements, and clinical pharmacy interventions. RESULTS: Of the 208 surveys e-mailed, 45 recipients responded, for an overall survey response rate of 22%. The responses were divided into 2 subgroups for the institutions that currently conduct phase 1 cancer clinical trials, including institutions with >40 active phase 1 cancer clinical trials and institutions with ≤40 active phase 1 cancer clinical trials. The institutions with >40 active phase 1 cancer clinical trials were more likely to have pharmacists involved with direct participant care (47% vs 18.8%, respectively) and document medication lists for phase 1 trial participants (41% vs 18.8%, respectively) than institutions with ≤40 active phase 1 cancer clinical trials. The survey results assisted in developing a framework to classify drug regimens as platinum level (ie, higher complexity) or standard level (ie, lower or average complexity) to prioritize clinical pharmacy services based on their complexity level. CONCLUSION: Our analysis of current phase 1 clinical trial pharmacy practices at NCI institutions enabled the development of a framework for increased collaboration with research teams and phase 1 clinical trial-specific clinical pharmacy services within Johns Hopkins Medicine SKCCC.

Establishing an investigational drugs and research residency at an academic medical center.

PURPOSE: The development, structure, and implementation of an innovative residency program designed to help meet a growing need for pharmacists with specialized expertise in investigational drug use and clinical research are described. SUMMARY: Clinical research has become an increasingly complex field, but prior to 2017 there were no U.S. specialty residency training programs focused on pharmacists' role in drug development and the care of patients enrolled in clinical trials. In 2016 Johns Hopkins Hospital (JHH) launched an initiative to develop residency training standards specific to the areas of investigational drug use and clinical research. The residency development process consisted of creation of a residency development committee; a needs assessment, including formation of a diverse panel of internal and external experts to guide identification of key competency areas and development of residency goals and objectives; design of the program's structure, including a framework for required and elective rotations; submission of an application for pre-candidate status to the ASHP Commission on Credentialing; and recruitment efforts. CONCLUSION: The JHH investigational drugs and research residency, a combined PGY1 and PGY2 program with 5 competency areas, 14 goals, and 49 objectives, was granted pre-candidate status by ASHP in November 2016. The first resident began the program in June 2017.

Participation of a coordinating center pharmacy in a multicenter international study.

PURPOSE: The activities of a coordinating center pharmacy (CCP) supporting a multicenter, international clinical trial are described. SUMMARY: Serving in a research support role comparable to that of a commercial clinical trial supply company, a CCP within the Johns Hopkins Hospital Investigational Drug Service (JHH IDS) uses its management expertise and infrastructure to support multicenter trials, such as the recently completed Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage, Phase III (CLEAR III) trial. The role of the CCP staff in supporting the CLEAR III trial was overall investigational product (IP) management through coordination of IP-related operations to ensure high-quality care for study participants at study sites in the United States and abroad. For the CLEAR III trial, the CCP coordinated IP supply activities; provided education to site pharmacists; developed study-specific documents, including pharmacy manuals; communicated with trial stakeholders, including third-party IP distributors; monitored treatment assignments; and performed quality assurance monitoring to ensure compliance with institutional, state, federal, and international regulations regarding IP procurement and storage. Acting as a CCP for a multicenter international study poses a number of operational challenges while providing opportunities for the CCP to contribute to research of global importance and enrich the skill sets of its personnel. CONCLUSION: The development and implementation of the CCP at JHH IDS for the CLEAR III trial included several responsibilities, such as IP supply management, communication, and database, regulatory, and finance management.