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.

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.

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.