Resources for Technical Assistance

For applications involving clinical studies that fall within the NIH definition of a clinical trial, NCCIH will not support clinical trials aiming to test efficacy/effectiveness (meaning the study is powered on a primary outcome that is a clinical assessment used in clinical diagnosis of disease or monitoring of disease severity) of an intervention as a part of an SBIR/STTR Phase I application. Applicants seeking to conduct efficacy or effectiveness clinical trials should pursue funding via other FOAs such as the Omnibus SBIR/STTR Phase II, Direct to Phase II, and Fast-Track. See NOT-AT-19-012 for “NCCIH Policy for SBIR and STTR Phase I Applications Proposing Clinical Trials to the Omnibus Solicitations.”

For applications involving clinical studies that fall within the NIH definition of a clinical trial, NCCIH will not support clinical trials aiming to test efficacy/effectiveness (meaning the study is powered on a primary outcome that is a clinical assessment used in clinical diagnosis of disease or monitoring of disease severity) of an intervention as a part of an SBIR/STTR Phase I application. Applicants seeking to conduct efficacy or effectiveness clinical trials should pursue funding via other FOAs such as the Omnibus SBIR/STTR Phase II, Direct to Phase II, and Fast-Track.

Not sure if your research is a clinical trial? The NIH definition of a clinical trial is, “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” For additional information on NCCIH’s clinical trial policy, visit our Clinical Trials section.