Director’s Blog: A New Approach to Clinical Trials

The Director of the National Institute of Mental Health takes a broad view of what constitutes effective treatment options.  He says “While experimental medicine has become an accepted approach for drug 

development, we believe it is equally important for the development of psychosocial treatments.”

Progress of treatment development for mental illnesses has been frustratingly slow. This week, NIMH released a series of funding announcements with important changes to how we'll fund clinical trials. Dr. Insel discusses these changes, which are aimed at setting us on a course to having the science base necessary for generating effective new therapeutics and validating those we have now.

NIMH has been in the spotlight lately for proposing the Research Domain Criteria or RDoC, a new framework for classifying mental disorders. One of the aims of RDoC is to help refocus clinical research, aligning it with what we are learning from biological, cognitive, and social science. This week, we are taking the first step in an initiative that, like RDoC, aims to realign research—but this time, the target is treatment development, an area in which progress has been frustratingly slow. In a series of funding announcements released this week, NIMH is making three important changes to how we will fund clinical trials.

First, future trials will follow an experimental medicine approach in which interventions serve not only as potential treatments, but as probes to generate information about the mechanisms underlying a disorder. Trial proposals will need to identify a target or mediator; a positive result will require not only that an intervention ameliorated a symptom, but that it had a demonstrable effect on a target, such as a neural pathway implicated in the disorder or a key cognitive operation. While experimental medicine has become an accepted approach for drug development, we believe it is equally important for the development of psychosocial treatments. It offers us a way to understand the mechanisms by which these treatments are leading to clinical change. Moreover, a subset of the funding announcements will support clinical trials that evaluate the effectiveness or increase the clinical impact of pharmacological, somatic, psychosocial, rehabilitative, and combination interventions.

http://www.nimh.nih.gov/about/director/2014/a-new-approach-to-clinical-trials.shtml?utm_source=govdelivery&utm_medium=email&utm_campaign=govdelivery