Notice Number: NOT-AT-19-012

Key Dates
Release Date: January 2, 2019

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

Purpose

The purpose of this Notice is to define the types of clinical trials/studies that may be submitted as a Phase I application to NCCIH in response to Funding Opportunity Announcements (FOAs) PA-18-573 and PA-18-576 (Parent SBIR and STTR Clinical Trial Required FOAs) and subsequent reissuances of these FOAs.

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 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 and Fast-Track.

NCCIH recognizes a difference between "clinical trials" that are designed to answer specific questions about the clinical effect of interventions and mechanistic studies that have the primary goal of understanding how an intervention works.

• A clinical outcome study has the objective of determining the clinical safety, tolerability, feasibility, efficacy and/or effectiveness of pharmacologic, non-pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions.
• A mechanistic study has the objective to understand the mechanism(s) of action of an intervention, a biological or behavioral process, or the pathophysiology of a disease/condition.

Examples of acceptable clinical trials for the SBIR/STTR phase I applications may include:

• basic experimental studies in humans,
• human mechanistic trials/studies,
• pilot feasibility testing of the proposed technology, device, or electronic system examining important questions about feasibility and acceptability that will directly inform the design and conduct of a future fully-powered clinical efficacy or effectiveness study

NCCIH continues to accept clinical trials of all types on Omnibus SBIR/STTR Phase II and Fast-Track applications.

Inquiries

Please direct all inquiries to:

Merav Sabri, PhD
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-496-2583
Email: merav.sabri@nih.gov

Anastasia Solis
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-8018
Email: anastasia.solis@nih.gov