This Funding Opportunity Announcement (FOA), utilizing the U24 grant funding mechanism, encourages applications for a collaborating Data Coordinating Center (DCC) application that accompanies an investigator-initiated multi-site clinical trial (Phase Ill and beyond) application submitted under PAR-18-117 (https://grants.nih.gov/grants/guide/pa-files/PAR-18-117.html. The DCC application must be specific to the collaborating Clinical Coordinating Center (CCC) application. The objective of the DCC application is to propose a comprehensive plan that provides overall project coordination, and administrative, data management, and biostatistical support for the proposed clinical trial. Both a DCC application and a corresponding CCC application need to be submitted simultaneously for consideration by NCCIH. Trials for which this FOA applies must be relevant to the research mission of the NCCIH and considered a high priority by the Center. For additional information about the mission, strategic vision, and research priorities of the NCCIH, applicants are encouraged to consult the NCCIH website: (http://www.nccih.nih.gov (http://www.nccih.nih.gov)). Applicants are encouraged to contact the appropriate the Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this FOA.
For applications submitted on or after January 25, 2018, the National Center for Complementary and Integrative Health (NCCIH) will no longer accept most clinical trial applications through the Parent R01 (See NOT-AT-18-001). 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) natural product studies and 2) mind and body intervention studies, targeting support of all phases of clinical intervention development.
- Mind and Body Clinical Trial Funding Opportunities
- Natural Product Clinical Trial Funding Opportunities
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. These 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
Our new FOAs will allow researchers to incorporate a larger amount of relevant information in their grant applications, which will be assessed by special review panels familiar with our research priorities and the goals of the new FOAs. Applicants using the new FOAs must provide details about their proposed clinical studies in a standardized way via additional required attachments.
With these new opportunities, we will support investigators working on the “building blocks” that bridge the gap from basic research to high-impact clinical trials. We’re providing pathways via these FOAs to support all developmental steps that may lead to major clinical trials on complementary and integrative health approaches.
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.” 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. Use the new FOAs listed below for clinical outcome studies.
When Can Applicants Still Use the Parent R01?
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; as well as animal or cell based studies. (See NCCIH Policy for Submission of Parent R01 Applications Proposing Clinical Trials, NOT-AT-18-001)
For More Information
- NCCIH Policy for Submission of Parent R01 Applications Proposing Clinical Trials (NOT-AT-18-001)
- NCCIH Clinical Trial Funding Opportunity Announcements—Applicant FAQs
- NCCIH Clinical Trial Funding Opportunity Announcements—Webinars
- Blog Post: NCCIH’s New Approach to Clinical Trials
- NCCIH Clinical FOAs Required Application Elements – Natural Products
- NCCIH Clinical FOAs Required Application Elements—Mind and Body
Mind and Body Clinical Trial Funding Opportunities
This Funding Opportunity Announcement (FOA) encourages applications for investigator-initiated multi-site clinical trials (e.g. efficacy, effectiveness or pragmatic trials) to study the effects of mind and body interventions in NCCIH designated areas of high research priority. Clinical Coordinating Centers should develop and implement the proposed multi-site clinical trial. The objective of a Clinical Coordinating Center application is to present the scientific rationale and a comprehensive scientific and operational plan for the clinical trial. Clinical Coordinating Center applications are expected to describe plans for project management, participant recruitment and retention strategies, performance milestones , scientific conduct, and dissemination of results. Clinical Coordinating Center applications submitted under this FOA will utilize a two-phase, milestone-driven cooperative agreement (UG3/UH3) funding mechanism . In addition, an accompanying Data Coordinating Center application, submitted under PAR-18-116 (https ://grants.nih.gov/grants/guide/pa-files/PAR-18-116.html) proposing a data analysis and data management plan for the clinical project is required. Both a Clinical Coordinating Center application and a corresponding Data Coordinating Center (DCC) application need to be submitted simultaneously for consideration by NCCIH. For additional information about the mission, strategic vision, and research priorities of the NCCIH, applicants are encouraged to consult the NCCIH website : (https://nccih.nih.gov/about/plans (https://nccih.nih.gov/about/plans )). Applicants are encouraged to contact the appropriate the Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this FOA.
The goal of this funding opportunity announcement (FOA) is to support early phase clinical trials of mind and body approaches for conditions that have been identified by NCCIH as high priority research topics. This funding opportunity is intended to support exploratory clinical trials, which will provide data that are critical for the planning and design of a subsequent controlled cohort study, clinical efficacy or effectiveness study, or a pragmatic trial. The data collected should be used to fill gaps in scientific knowledge necessary to develop a competitive full-scale clinical trial. This FOA is not appropriate for support of randomized clinical trials to test or determine efficacy or effectiveness. Applications that propose solely to write a protocol or manual of operations or to develop infrastructure for a clinical trial are not appropriate for this announcement. The subsequent larger trial should have the potential to make a significant impact on public health.
See Required Application Elements
Understanding the mechanisms by which complementary or integrative Mind and Body Interventions exert their clinical effects is critical for the development of optimized interventions that target specific conditions and disorders.
See Required Application Elements
Understanding the mechanisms by which complementary or integrative Mind and Body Interventions exert their clinical effects is critical for the development of optimized interventions that target specific conditions and disorders.
See Required Application Elements
This Funding Opportunity Announcement (FOA) invites cooperative agreement applications for investigator-initiated clinical trials of mind and body interventions in NCCIH-designated areas of high research priority. Applications submitted under this FOA are expected to propose a clinical trial to develop and test adaptive interventions; optimize the intervention by evaluating which element of a complex intervention are critical for changes in outcome; assessing whether the intervention can be delivered with fidelity across sites in preparation for a future multi-site trial; or collect additional preliminary data such as determining the duration or frequency of the intervention to be used in a future multi-site trial. It is important, therefore, to already have sufficient preliminary data that includes: demonstration of feasibility of recruitment and accrual of participants; demonstration of participant adherence to the intervention as well as retention of participants throughout the study; completion of final data collection from any related studies; and evidence that the intervention has promise of clinical benefit. This FOA is not intended to support multi-site efficacy or effectiveness trials, nor will it support trials to test mind and body interventions for the treatment or prevention of cancer.
See Required Application Elements
This Funding Opportunity Announcement (FOA) encourages research grant applications (R01) to investigate the fundamental science of mind and body approaches, including mind/brain-focused practices (e.g., meditation, hypnosis), body-based approaches (e.g., acupuncture, massage, spinal manipulation/mobilization), meditative exercise (e.g., yoga, tai chi, qi gong), art and music therapies, or integrative approaches combining several components. Studies of pharmacologic approaches exclusively are not included in the scope of this FOA.
This funding opportunity announcement (FOA) encourages exploratory /developmental research grant applications (R21) to investigate the fundamental science of mind and body approaches, including mind/brain-focused practices (e.g., meditation, hypnosis), body-based approaches (e.g., acupuncture, massage, spinal manipulation/mobilization), meditative exercise (e.g., yoga, tai chi, qi gong), art and music therapies, or integrative approaches combining several components. Studies of pharmacologic approaches exclusively are not included in the scope of this FOA.
*UG3/UH3 and U24 are companion announcements. Investigators must submit applications to both FOAs together.
Natural Product Clinical Trial Funding Opportunities
This Funding Opportunity Announcement (FOA) encourages applications for investigator-initiated early phase clinical trials of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This FOA will provide up to 3 years support for studies to replicate the impact of the natural product on the biological signature(s) when used by humans and assess whether there is an association between the degree of the impact on the biological signature and functional or clinical outcomes in a patient population. Applications can design studies to determine how to optimize the impact of the natural product on the biological signature by (1) optimizing the delivery of the natural product by dose or formulation; (2) combine the natural product with another treatment approach that is known to impact the same biological signature; or (3) study the impact of the natural product in a target population that is more responsive. Clinical trials submitted under this FOA are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. This R33 funding mechanism is intended to accelerate the translation of emerging basic science findings about natural products into early stage clinical testing to determine whether continued clinical research is warranted. This FOA will not support efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer.
This Funding Opportunity Announcement (FOA) encourages applications for investigator-initiated early phase clinical trials of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This FOA will provide up to two years (R61 phase) of support for milestone-driven testing of bioavailability, pharmacokinetics, and assessment of the natural products effect (i.e., measure of mechanism of action) when used by humans on a biological signature(s). If milestones in the R61 phase are achieved, up to 3 years of additional support (R33 phase) may be awarded to replicate the impact of the natural product on the biological signature(s) when used by humans and assess whether there is an association between the degree of the impact on the biological signature and functional or clinical outcomes in a patient population. Applications can design R33 studies to determine how to optimize the impact of the natural product on the biological signature by (1) optimizing the delivery of the natural product by dose or formulation; (2) combine the natural product with another treatment approach that is known to impact the same biological signature; or (3) study the impact of the natural product in a target population that is more responsive. Clinical trials submitted under this FOA are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. This R61/R33 funding mechanism is intended to accelerate the translation of emerging basic science findings about natural products into early-stage clinical testing to determine whether continued clinical research is warranted. This FOA will not support efficacy or effecti
This Funding Opportunity Announcement (FOA) , utilizing the U24 grant funding mechanism, encourages applications for a collaborating Data Coordinating Center (DCC) application that accompanies investigator-initiated, multi-site clinical trials (Phase III and beyond) applications submitted under PAR-18-124 (https://grants.nih.gov/grants/guide/pa-files/PAR-18-696.html). The DCC application must be specific to the collaborating Clinical Coordinating Center (CCC) application. The objective of the DCC application Is lo propose a, comprehensive plan that provides overall project coordination. and administrative, data management and biostatistical support for the proposed clinical trial. Both a DCC application and a corresponding CCC application need to be submitted simultaneously for consideration by NCCIH. Trials for which this FOA applies must be relevant to the research mission of the NCCIH and considered a high priority by the Center. For additional information about the mission, strategic vision, and research priorities of the NCCIH, applicants are encouraged to consult the NCCIH website: (https://www,nocih.nih.gov) . Applicants are encouraged to contact the appropriate Scientific/Research contact for the area of science for which they are planning to develop an application prior lo submitting to this FOA.
See Required Application Elements
This Funding Opportunity Announcement (FOA) encourages cooperative agreement applications for investigator-initiated multi-site clinical trials (Phase III and beyond) to study the effects of natural products in NCCIH designated areas of high research priority. Applicants should describe plans for a Clinical Coordinating Center to develop and implement the proposed multi-site clinical trial. The objective of the Clinical Coordinating Center is to provide the design scientific rationale and a comprehensive scientific and operational plan for the clinical trial. The Clinical Coordinating Center is expected to be responsible for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. Clinical Coordinating Center applications submitted under this FOA will utilize a two-phase, milestone-driven cooperative agreement (UG3/UH3) funding mechanism. In addition, an accompanying Data Coordinating Center application, submitted under PAR-18-123 ( https://grants.nih.gov/grants/guide/pa-files/PAR-18-697.html), proposing a data analysis and data management plan for the clinical project is required. Both a Clinical Coordinating Center application and a corresponding Data Coordinating Center (DCC) application need to be submitted simultaneously for consideration by NCCIH.
See Required Application Elements
This Funding Opportunity Announcement (FOA) invites cooperative agreement applications for investigator-initiated clinical trials of natural products to treat clinical symptoms such as those associated with sleep disturbance, pain conditions, or some mental health conditions (e.g., mild to moderate depression, anxiety, and post-traumatic stress), or examine the effects of probiotics and other natural products on gut-microbiome interactions with the brain and/or immune system. All applications submitted under this FOA must be supported by sufficient preliminary data of bioavailability and documentation that the natural product produces a replicable and measurable biological signature (i.e., measure of the mechanism of action), whenever it is possible or practical to measure and used by the patient population of interest.
See Required Application Elements
*UG3/UH3 and U24 are companion announcements. Investigators must submit applications to both FOAs together.