ISPE Issues Guidance for Clinical Trials Comparator Management

Guide explains issues related to comparator sourcing, outlines strategies for saving time and money in regards to comparator management.

PRweb: Tampa, Florida USA (PRWEB) March 01, 2012.

ISPE announced today that it 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.” Read More