The International Society for Pharmaceutical Engineering (ISPE) has issued important industry guidance to advise clinical trials on comparator management activities. The ISPE Good Practice Guide: Comparator Management is the pharmaceutical industry’s first-ever resource for comparator processes such as product sourcing and blinding. The Guide explains the risks involved with ineffective comparator methods, and provides companies with strategies for avoiding the costs, delays, and potential case study inaccuracies that might result from faulty comparator management.
“With the industry’s increased focus on proving drug effectiveness when compared to other, similar pharmaceuticals, comparator management is becoming increasingly important,” said Mark Ware, one the Guide’s authors. “There are so many factors to consider when sourcing and preparing a comparator product for use in a clinical trial, and a mistake in the process could cost companies literally millions of dollars. Clearly, the pharmaceutical industry has an urgent need for a document like this one, and ISPE was the perfect forum for pulling together the industry expertise needed to create it.”
The Comparator Management Good Practice Guide is a central reference source that establishes strategic and tactical considerations related to comparator sourcing. It identifies good practices for making sourcing decisions, including how to set up a good sourcing team. The Guide also discusses good practices for blinding and releasing a comparator for use. These strategies can save companies sponsoring clinical trials significant time and money.
The ISPE Good Practice Guide: Comparator Management is available for purchase from ISPE at www.ISPE.org/ISPE-Good-Practice-Guides/Comparator-Management.
ISPE is a not-for-profit Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, FL; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for additional news and information.