The goal of the Investigational Drug Service Shared Resource (IDS) is to provide a centralized resource for comprehensive pharmacy support for all Clinical Investigators and patients enrolled in clinical trials at Roswell Park. IDS establishes and implements processes and procedures that ensure study drug use is in accordance with all federal, state, institutional, and sponsor regulations governing clinical research. The IDS provides a wide array of services tailored to the clinical protocol-specific needs, including critically important services to Roswell Park CCSG members that ensure regulatory rigor, high quality pharmacy services and including preparation of investigational agents, and safety of clinical trial participants. The IDS is critical for facilitating the conduct of treatment intervention clinical trials by maintaining regulatory rigor and subject safety. IDS has been delegated all aspects of investigational drug management in order to ensure safe provision of study medications to research subjects enrolled in treatment intervention clinical trials. Importantly, IDS leadership and staff are members of the Early Phase Clinical Trial (EPCT) unit and can support the development of all early phase translational trial development. In conjunction with Dr. Robert Bies (Bioanalytics, Metabolomics & Pharmacokinetics Shared Resource), who is also a member of EPCT, IDS supports development of clinical pharmacology aspects of CCSG program protocols. In the reporting period (2013-2017), the IDS served a total of 73 Roswell users, of which 44 (60%) were CCSG members.
The Specific Aims of the IDS are: 1) To evaluate treatment intervention clinical trials for feasibility and facilitate protocol review: IDS participates in the PRMS process for all treatment intervention clinical trials; 2) To manage investigational agents for all treatment intervention clinical trials in accordance with Good Clinical Practice (GCP) standards: IDS has developed standard operating procedures for ordering, receiving, storage, dispensing, preparation and destruction of all study medications; 3) To provide clinical services essential for safety of patients participating in treatment intervention clinical trials: IDS pharmacists ensure patient safety by (i) assessing for potential drug interactions with investigational agents; and (ii) providing education for patients taking investigational agents at home to ensure patient safety and data integrity. In alignment with Roswell Park's strategic plan to enhance innovative cancer care especially in immunotherapy and precision medicine, it is anticipated that the complexity of treatment intervention clinical trials will continue to increase over the next five years.
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