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ISPE

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ISPE Issues Guidance for Clinical Trials Comparator Management

Pharmaceutical industry resource for product sourcing and blinding

Published: Tuesday, March 6, 2012 - 13:20

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a society for professionals involved in the engineering and manufacture of pharmaceuticals and related products, has issued 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. It identifies good practices for making sourcing decisions, including how to set up a good sourcing team. The guide discusses good practices for blinding and releasing a comparator for use. It also 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,” says 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 strategies outlined in the guide can save companies that sponsor clinical trials significant time and money.

The ISPE Good Practice Guide: Comparator Management is available for purchase from ISPE here.

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ISPE

The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.