Clarification on Collaborative Sites for PA-09-075 – Collaborative R34s for Pilot Studies of Innovative Treatments in Mental Disorders (Collaborative R34)

Notice Number: NOT-MH-11-013

Key Dates
Release Date: July 7, 2011

Issued by
National Institute of Mental Health (NIMH)

Purpose

The objective of PA-09-075 is “to support collaborative preliminary intervention studies to evaluate the feasibility, tolerability, acceptability and safety of novel mechanism drug candidates, promising investigational new drugs (INDs), or novel psychosocial strategies for the treatment of mental disorders and for obtaining the preliminary data needed as a pre-requisite to larger-scale (efficacy or effectiveness) intervention or service studies.” Further, “The collaborating studies should be organized in order to increase sample size, accelerate recruitment, and/or increase sample diversity and representation.” It is “expected that each application will be coordinated and interlocked with the others as each application will contribute an essential component to the overall study. In the case of multi-site clinical trials, it is anticipated that the same protocol will be submitted by each site.”

To date, some applications in response to this Funding Opportunity Announcement (FOA) have included those proposing collaborative studies/sites with different protocols and/or combinations of recruiting and non-recruiting sites.

This purpose of this Notice is to clarify that in order to “increase sample size, accelerate recruitment, and/or increase sample diversity and representation” and achieve the objective of this FOA, applications proposing collaborative R34 studies/applications must implement a common clinical research protocol, in parallel, across all collaborative studies/applications and that recruitment of subjects should take place at all collaborative studies/applications. NIMH recognizes that “there are likely to be elements unique to some sites (e.g., data coordination, fidelity assessment, statistical analyses).” However, applications that propose collaborative studies/applications with different protocols and methodologies or in which no subjects will be recruited, will not be considered appropriate to the goals of this FOA.

Inquiries

Inquiries regarding this Notice may be directed to:

Mi Hillefors, M.D., Ph.D.
Division of Adult Translation Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7125, MSC 9632
Bethesda, MD 20892-9632
Telephone: (301) 443-1692
FAX: (301) 443-1425
Email: mi.hillefors@nih.gov


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