National Comprehensive Cancer Network investigational drug service consensus recommendations
Sapna Amin, Stephen Polley, Sean DeFrates, Heidi D. Finnes, Katharine Kinsman, Elyse A. MacDonald, Latanya Dean, Lorri L. DeWitt, Caroline Harvey, Susan Johnston, Tzewah Vivian Leung, Emily A Moll, Gerald P. O’Neill, Kimberly Redic, Sharon F Park
Abstract
Participation in clinical research is essential to advancing the science of cancer care. In the 2011 statement on necessary attributes of an exemplary clinical trial site, the American Society of Clinical Oncology emphasized that a multidisciplinary team is necessary for an organization to be successful in the conduct of clinical research.1 Pharmacists play a crucial role in investigational product (IP) acquisition, detailed drug accountability, and safe drug dispensation to clinical trial participants. The duties of the pharmacist in investigational drug services (IDS; hereafter, this abbreviation is used for both singular and plural usages) have been well defined by the American Society of Health-System Pharmacists (ASHP) and Hematology/Oncology Pharmacy Association (HOPA).2-4 Pharmacists have an in-depth knowledge of the clinical trial protocol, eligibility criteria, and potential drug-drug interactions and toxicities associated with IP.4 In addition, they understand the regulatory requirements of IP, as issued by the Food and Drug...