National Center for Complementary and Alternative Medicine (NCCAM)

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Information on Submitting Preliminary Clinical Studies for Large Interventional Trials of CAM (R34)

If you are considering a request for NCCAM's permission to submit a preliminary clinical study for large interventional trials of CAM (R34) application (PAR-10-163), please think through the items below in preparation for speaking with an NCCAM program director and/or submitting a written request for permission to submit. It is strongly recommended that you speak with an NCCAM program director before submitting an approval request letter.

The National Center for Complementary and Alternative Medicine (NCCAM) will require eight weeks to review Preliminary Clinical Studies for Large Intervention Trials of CAM (R34) application submission requests. Please consider this when constructing the grant application submission timeline. An approval letter from NCCAM must be included with the application package.

Your written request for approval must be no longer than 5 pages (Arial 11 pt font; 0.5 inch margins). The details included in your letter may vary depending on the type of study planned (e.g., epidemiology study, natural product trial, mind-body intervention). Generally, the letter should include all of the following items:

  • Date of Proposed Submission
  • Study title
  • Study PI (including biosketch, which does not count in page limit)
  • Primary institution
  • Total cost for the R34
  • Study objective or objectives
  • Rationale
    • Scientific basis for and clinical significance of the proposed clinical trial
    • Potential impact on public health
  • Summary of how project addresses the priority areas identified by NCCAM
  • Study design or flow diagram depicting study
  • Proposed start date, duration, and timeline of the proposed study
  • Estimated sample size, and its rationale
  • Feasibility to successfully undertake the study
  • General statistical assumptions for the proposed study design and analysis
  • Product/intervention to be evaluated and how it will be obtained, if applicable
    • Industry partner, if applicable
    • Brief summary of risk information, e.g., available safety data, such as the product label, for the product. Also, include a description of regulatory issues that have/need to be resolved, e.g. have IND/need IND
    • Brief summary of the proposed intervention protocol
    • Proposed plans for identification and training of individuals who will provide the study intervention
  • Summary of how the proposed R34 work will lead to a larger clinical study and an overview of the design and impact of the larger clinical study