NCCIH Policy on Support of Clinical Trials in NIH Pathway to Independence Award (K99/R00)

Notice Number: NOT-AT-15-007

Key Dates
Release Date:   July 8, 2015

Related Announcements
PA-15-083    

Issued by
National Center for Complementary and Integrative Health (NCCIH)

Purpose

The purpose of this Notice is to inform potential applicants to the NIH parent K99/R00 Funding Opportunity Announcement (FOA) PA-15-083, that, effective with application submitted on October 12, 2015, and subsequently, NCCIH will not accept applications to this program which propose a K99 phase that includes conducting a new clinical trial with the goal of evaluating the efficacy or effectiveness of an intervention. Applicants may propose that the K99 phase include mechanistic studies of complementary or integrative interventions as long as the study does not propose to be powered to measure clinical outcomes such as efficacy or effectiveness. K99 applications can propose ancillary studies to ongoing clinical trials, if the clinical trial is funded by sources other than the K99 award. 

In the R00 phase of the award, the applicant can include clinical research studies.  Applicants proposing clinical research should carefully consider whether or not the aims can be completed within the time and budget allowed in the R00 phase.   Because of these limits, NCCIH does not recommend applicants incorporate fully powered phase 3 clinical trials to evaluate efficacy or effectiveness of complementary or integrative health approaches in the R00 phase.  Potential applicants are strongly encouraged to contact NCCIH program staff to discuss the scope of research proposed in the K99 and R00 phases. 

Inquiries

Please direct all inquiries to:

John Williamson, PhD
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-496-2583
Email: john.williamson@nih.gov