The National Institute of Mental Health (NIMH) is rolling out new rules for clinical trials testing psychiatric drugs or interventions. For years, applications have proposed testing to see if Drug X helps with a particular condition, like depression, schizophrenia, anorexia etc.
If a drug does show an effect on the particular condition being tested, we have learned that we may have a new treatment for that condition. “Hooray!” If a drug does not show an effect on the particular condition being tested, we have learned that we may not have a new treatment for that condition, which is pretty much what we knew before the expensive clinical trial.
The NIMH has created new funding rules in an attempt to address this issue.
The director of the NIMH Dr. Tom Insel explained the new rules in a recent blog post. Essentially, the NIMH will no longer fund a trial that does not also seek to understand something fundamental about the brain, the action of the treatment, or how the disease actually affects a person. They are also encouraging more transparency and planning to increase the speed at which data is gathered and shared with the public. I understand exactly why these new measures are being put into place and the benefits they could bring, but I think it’s a bit more complicated.
Designing a clinical trial was already incredibly complicated. These new rules require an almost a full secondary study. To study the effects of a treatment on the brain it will be important to observe the right cells at the right time. There will need to be assays and biomarkers to allow more detailed study of a particular treatment. While some assays and biomarkers exist currently, for many other molecules or conditions that will be necessary to measure, they simply have not been developed yet. The field is may not be ready to have clinical trials linked to experimental mechanistic measurements. It may even cause there to be fewer clinical trials, because they will not be able to meet this standard.
I understand where the NIMH is coming from. You never want to end a clinical trial investment with nothing. I’m curious to see if the field is able to successfully design trials that meet this standard. Perhaps these new rules will promote development of the needed tools that currently do not exist. There really is a dearth of treatments and knowledge on many psychiatric conditions, hopefully these steps will make the field more efficient and effective in uncovering the underpinnings of these illnesses.