The National Center for Complementary and Integrative Health (NCCIH) no longer accepts most clinical trial applications through the Parent R01 (See NOT-AT-19-011). NCCIH has published a series of clinical trial-specific Funding Opportunity Announcements (FOAs) for investigators to use instead of the Parent R01. They focus on 1) mind and body intervention studies and 2) natural product studies, targeting support of all phases of clinical intervention development.
Clinical trials are particularly important to NCCIH. We study health interventions widely used by the American public—interventions often used with scarce evidence of efficacy. We see substantial promise in many of these interventions, but we recognize that the evidence supporting their use is often incomplete. Our clinical trial FOAs will help to address gaps in current research and build a strong evidence base.
NCCIH Clinical Trial FOAs Support Continuum of Clinical Research
With the continuum of available NCCIH clinical trial FOAs, we support investigators working on the “building blocks” that bridge the gap from basic research to high-impact clinical trials. We provide pathways via these FOAs to support all developmental steps that may lead to major clinical trials on complementary and integrative health approaches. Applications to nearly all of the NCCIH clinical trial FOAs listed below will be assessed by special emphasis review panels familiar with our research priorities and the goals of each FOA.
The National Institutes of Health (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). NIH defines a mechanistic study (which can be a type of clinical trial) as: “A mechanistic study is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.”
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, nonpharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions.
NCCIH has developed a range of FOAs to support mechanistic research and research on clinical outcomes that support the full spectrum of human subjects research.
NCCIH Framework for Human Subjects Research
How NCCIH Uses the Parent R01 for Human Subjects Research
The NIH now offers three options for the Parent R01 (see comparison of FOA types by clinical trial allowability):
Parent R01 Clinical Trial Not Allowed (PA-19-056): NCCIH will continue to accept applications to this FOA for observational studies such as survey studies, cohort studies, or case-control studies, as well as secondary analyses of existing data sets or banked samples.
Parent R01 Clinical Trial Required (PA-19-055): NCCIH will only accept applications that propose human mechanistic trials/studies; no applications will be accepted that include any specific aims that propose to assess efficacy or effectiveness of any intervention (see NOT-AT-19-011).
Parent R01 Basic Experimental Studies with Humans Required (PA-19-091): NCCIH will accept applications that propose basic science experimental studies involving humans, referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants.” These studies assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.
NCCIH has developed a suite of clinical trial FOAs to support the full range of clinical trial types for both mind and body and natural product interventions. Investigators are strongly encouraged to apply to one of NCCIH’s clinical trial FOAs (see Tables below) instead of the Parent R01 FOAs. Applicants are encouraged to contact firstname.lastname@example.org for initial advice on choosing an FOA to match their stage of science. Once applicants have chosen a specific FOA and developed a specific aims page, they are encouraged to contact the Scientific Research contact listed in the FOA and in the table below for further feedback prior to applying.
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