NOT-AT-17-006: NCCIH Policy for Submission of Parent R01 Applications Proposing Clinical Trials

NCCIH Policy for Submission of Parent R01 Applications Proposing Clinical Trials

Notice Number: NOT-AT-17-006

Key Dates
Release Date: March 29, 2017 ( This notice will be rescinded on January 9, 2018)

Related Announcements
PA-16-160
PA-16-161
NOT-OD-15-015
PAR-14-182
PAR-17-149
PAR-17-162
PAR-17-215
PAR-17-173
PAR-17-175
PAR-16-418
PAR-16-419
PAR-17-216
PAR-17-174
PAR-17-172

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

Purpose

The purpose of this Notice is to define the types of clinical studies that may be submitted to NCCIH in response to the NIH Parent R01 Funding Opportunity Announcements (FOAs) PA-16-160 and subsequent reissuances of this FOA.

After May 8, 2017, NCCIH will not accept R01 applications that propose clinical trials in response to PA-16-160 . NIH defines a clinical trial as 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. (NOT-OD-15-015 ) NCCIH has published a series of clinical trial specific FOAs for investigators to submit applications (see below).

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 mechanistic study is defined as one designed to understand the mechanism of action of an intervention, a biological process, or the pathophysiology of a disease.
A clinical outcome study is defined as one with 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.

NCCIH will continue to accept R01 applications via PA-16-160 that propose a study with human participants when the primary outcome/endpoint is explicitly mechanistic, rather than a clinical outcome, even if the mechanistic study meets the NIH definition of a clinical trial. However, NCCIH will not accept applications via PA-16-160 proposing mechanistic studies that include any specific aim(s) to measure efficacy or effectiveness. NCCIH will continue to accept applications via PA-16-160 for observational studies such as secondary data analysis, survey studies, cohort studies, or case-control studies.

NCCIH encourages applications for clinical trials through the FOAs listed below and through FOAs in which NCCIH participates that are issued by other NIH Institutes and Centers. A list of these FOAs can be found on the NCCIH website (https://nccih.nih.gov/grants/funding ).

Applicants submitting to NCCIH investigator-initiated applications that contain a clinical trial may use one of the NCCIH FOAs (or their reissuances) specifically designed for clinical trials with clinical outcomes.

Mind and Body Clinical Trial FOAs:

Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics (R34) PAR-14-182
Phased Innovation Award for Mechanistic Studies to Optimize Mind and Body Interventions in NCCIH High Priority Research Topics (R61/R33) PAR-17-149
Innovation Award for Mechanistic Studies to Optimize Mind and Body Interventions in NCCIH High Priority Research Topics (R33) PAR-17-162
NCCIH Mind and Body Clinical Trial Cooperative Agreement (U01) PAR-17-215
Collaborative FOAs for Multi-Site Investigator Initiated Clinical Trials of Mind and Body Interventions Clinical Coordinating Center UG3/UH3 PAR-17-175 and Data Coordinating Center (U24) PAR-17-173

Natural Product Clinical Trial FOAs:

Phased Innovation Award for Exploratory Clinical Trials of Natural Products in NCCIH High Priority Research Topics (R61/R33) PAR-16-418
Exploratory Clinical Trials of Natural Products in NCCIH High Priority Research Topics (R33) PAR-16-419
NCCIH Natural Product Clinical Trial Cooperative Agreement (U01) PAR-17-216
Collaborative FOAs for Multi-Site Investigator Initiated Clinical Trials of Natural Products Clinical Coordinating Center (UG3/UH3) PAR-17-174 and Data Coordinating Center (U24) PAR-17-172

NCCIH encourages applicants to consult with NCCIH Program Officials prior to submitting an application with human subjects to determine which available FOA will best support the proposed research.

Inquiries

Please direct all inquiries to: NCCIHDERInquiries@mail.nih.gov