Purpose: Research pharmacy effort required to safely and compliantly manage investigational products (IP) varies between studies. No validated tool exists in the United States to evaluate these differences in effort. The Vizient Pharmacy Research Committee Investigational Drug Services (IDS) Subcommittee previously developed a systematic complexity scoring tool (CST) through expert consensus to assign a complexity score for pharmacy effort.
View Article and Find Full Text PDFPurpose: The process of providing treatment with investigational drugs through expanded access is explained. Roles and informational resources for pharmacists are discussed.
Summary: Expanded access is a regulatory pathway for the treatment of serious or life-threatening diseases or conditions with investigational agents outside of clinical trials.
Am J Health Syst Pharm
December 2019