NIMH will implement new clinical trials recruitment policy

NIMH will implement new clinical trials recruitment policy

Beginning June 1, the National Institute of Mental Health will start a new policy for the recruitment and retention of participants in NIMH clinical research studies. The new policy grows out of concern that NIMH-funded clinical trials are routinely meeting less than 80% of their target recruitment goals.

Modeled after a policy at the National Heart, Lung and Blood Institute, the new policy will ask grantees conducting studies with 150 or more human subjects to report on recruitment three times per year. The recruitment milestones will be included as conditions of the award.

If recruitment falls significantly below the milestones, NIMH could take several courses of action. The first would be calling the principal investigator (PI) and asking why recruitment has fallen off track. That call could lead to brainstorming other opportunities for recruitment. For example, investigators could partner with community groups or take advantage of NIMH’s mental health patient network.

If problems persist, the institute could consider putting limits on dollars spent on the award until a certain level of recruitment is met. The measure of last resort is early phase out of the award.