Clarification of Requirements for Preliminary Clinical Studies in Preparation for Large Interventional Trials of Complementary and Alternative Medicine (CAM) Therapies (R34), PAR-10-163

Notice Number: NOT-AT-12-001

Release Date: October13, 2011

National Center for Complementary and Integrative Health (NCCIH formerly NCCAM)

This Notice is to clarify the purpose and requirements and update priority areas (http://nccam.nih.gov/grants/r34/priorities/) for Funding Opportunity Announcement PAR-10-163, Preliminary Clinical Studies in Preparation for Large Interventional Trials of Complementary and Alternative Medicine (CAM) Therapies (R34) (https://grants.nih.gov/grants/guide/pa-files/PAR-10-163.html).

The National Center for Complementary and Alternative Medicine (NCCAM) issued this Funding Opportunity Announcement (FOA) with the goal of supporting clinical studies needed to define the appropriate patient population, optimize the intervention strategy, or identify the appropriate outcome measures. These issues are as important for complementary and alternative medicine as for any area of medical research.

This funding opportunity (PAR-10-163) is appropriate when there is a need for additional clinical studies to justify design aspects of a future larger clinical study.

Investigators interested in pursuing areas of research not included in the priority areas for this funding opportunity (http://nccam.nih.gov/grants/r34/priorities/) should consult the NCCAM website for other available funding opportunities (http://nccam.nih.gov/grants/).

Applicants are advised of the following:

         Applications need to provide a strong justification in the Research Strategy Section

that there is scientific evidence demonstrating the need for larger clinical studies. In addition, there must be a solid justification and rationale for the clinical study proposed in the application and why it is necessary before larger studies can be performed. There must be a clear description about how the findings of the proposed study will be useful in aiding the design of future investigations and planning for a larger clinical study.

• Proof of concept studies is not appropriate for this funding opportunity.
• Applications must include an investigative team that has experience with all aspects of the proposed study and a track record to demonstrate that the team could move forward with a larger clinical study.
• Consistent with NIH policy, applications proposing the use of natural products in human studies must provide information on the status of the Investigational New Drug application with the Food and Drug Administration.
• While there are many areas of research with scientific promise and potential, NCCAM is currently only accepting applications with an emphasis on the new NCCAM designated high priority topics for CAM for this funding opportunity (http://nccam.nih.gov/grants/r34/priorities/).

Permission to Apply Requirement

• Applicants (including resubmissions) must obtain written approval from the NCCAM Director of Extramural Research (DER) or designee before submitting a R34 application. This letter must be included when submitting the R34 application. All requests must address items listed at the following website: http://nccam.nih.gov/grants/r34/letter.  These materials must be submitted to NCCAM eight weeks prior to the planned receipt date.

All other aspects of this FOA remain unchanged.

Please direct all inquiries to:

Wendy Weber, ND, PhD, MPH.
Division of Extramural Research
National Center for Complementary and Alternative Medicine (NCCAM)
6707 Democracy Blvd. Suite 401 
Bethesda, MD 20892-5475 (use 20817 for private courier services)
Telephone: (301) 402-1272
Fax: (301) 480-1587
Email: [email protected]