About Donald L. McKenzie, Ph.D. and Mark A. Osinski, Ph.D.

Dr. McKenzie is currently Executive Director of Drug Metabolism at Covance. Dr. Osinski is Study Director of Global Safety Pharmacology at Covance.

Integrated Solutions: Combining Multiple Endpoints into a Single Study Delivers Greater Confidence

covance_knife“The whole is greater than the sum of its parts” is often quoted to inspire teamwork and synergy but it can also apply to drug development. Studies that assess endpoints in isolation have value and can achieve the desired outcome.  Yet, many times a more complicated picture emerges and assessing multiple endpoints in a combined study reveals a more holistic view.

Inspired by the 3Rs—reduction, refinement and replacement of animals used in safety testing—the possibility of integrating multiple endpoints into one study is shaping new best practices in early drug development. Integrated solutions can maximize the value of each study to provide a better understanding, reveal earlier decision points and produce greater confidence in clinical outcomes.

While the concept seems straightforward, it’s not only a combination of otherwise standalone studies. Integrated solutions require a unique blend of fit-for-purpose experimental strategies tailored to each unique drug development program and the relevant endpoints. Continue reading