Strategic Comparator Sourcing

As a population, we have greater access to information than ever before. Couple this with challenging economic times and the result is an environment in which things are no longer accepted at face value. This trend is impacting all industries, including drug development.

The State of Comparative Effectiveness
Given this climate, intensified interest in comparative trials should come as no surprise.1,2,3 Economists, insurers, health care professionals, and the public seek more compelling evidence on how drugs compare in safety, efficacy, and cost. At the same time, governments around the world are promoting the use of comparative effectiveness trials in an attempt to control the inflation of health care costs and provide additional information in support of the approval process (see sidebar).

Investment in these trials is expected to increase as companies seek to better demonstrate the value of new therapies and make the case for inclusion in hospital and government formularies and reimbursement under insurance coverage.

Comparative effectiveness studies for new drugs, however, are not yet commonplace. Most often, clinical trials compare investigational drugs to placebos rather than subjecting the drugs to rigorous evaluation against existing treatments. While comparison against a placebo is generally required by regulatory authorities, trials must also include an active comparator when a pharmaceutical company seeks to claim superiority versus the competitor drug in its marketing materials; or an active comparator may be the only control agent in cases where giving trial participants a placebo would not be ethical.