Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics (R34) | Apply Online

FAQs: NIH PAR-14-182 (R34) - Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics

1) What is PAR-14-182?

PAR-14-182 is an NIH funding opportunity announcement titled "Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics (R34)." It supported early phase, exploratory clinical trials focused on mind and body interventions in research areas identified by NCCAM (now NCCIH) as high priority topics.

2) Which NIH center administered this opportunity?

The program was administered by the National Institutes of Health (NIH) through NCCAM, which is now known as the National Center for Complementary and Integrative Health (NCCIH).

3) What type of grant mechanism was used?

This opportunity used the R34 mechanism, which is intended for early phase, exploratory clinical trials that generate clinical trial data to reduce uncertainty before a larger, more definitive study is launched.

4) What was the central purpose of this FOA?

The purpose was to fund exploratory clinical trials that produce real clinical trial data addressing key scientific gaps that commonly prevent a strong, competitive full-scale trial. The expectation was that the resulting data would directly inform planning and design of a later-stage study (for example, a controlled cohort study, a full clinical efficacy/effectiveness trial, or a pragmatic trial in real-world settings).

5) What kinds of interventions were the focus?

The announcement focused on mind and body interventions, but only when the clinical trial topic fell within NCCAM/NCCIH-identified "high priority research topics."

6) Did this FOA fund definitive randomized controlled trials (RCTs) to test efficacy or effectiveness?

No. The FOA explicitly stated it was not intended to support randomized clinical trials designed to test or determine efficacy or effectiveness. In other words, it was not meant for a definitive, hypothesis-confirming RCT aimed at answering the final question of whether an intervention works.

7) What types of research gaps was the R34 meant to address?

It was positioned to address gaps such as feasibility, intervention optimization/refinement, and measurement questions that need to be resolved before investing in a larger trial.

8) What are examples of feasibility questions this FOA aimed to support?

Examples included whether the target population can be recruited and retained, and whether the intervention can be delivered with fidelity across providers or study sites.

9) What are examples of optimization and refinement questions relevant to this FOA?

Examples included determining the appropriate dose, session frequency, or delivery format for the intervention, and identifying a sensible comparator for the study design.

10) What are examples of measurement questions this FOA aimed to address?

Examples included selecting outcomes that are sensitive and credible, estimating variance needed for future power calculations, and evaluating adherence or engagement metrics that may predict response.

11) Did applications need to collect clinical trial data?

Yes. The expectation was that projects would generate meaningful clinical trial data, not just conceptual plans, and that those data would inform the design of a subsequent, larger study.

12) Were purely administrative or "paper-only" preparation activities allowed?

No. Applications that only proposed activities such as writing a protocol, creating a manual of operations, or building trial infrastructure without collecting meaningful clinical trial data were described as nonresponsive to this announcement.

13) What was the longer-term vision or intended impact of the program?

The longer-term vision was public health impact: exploratory work was expected to set up a later, larger trial with a realistic chance of changing clinical understanding or care for a meaningful health problem.

14) Was cost sharing or matching required?

No. The opportunity indicated that no cost sharing or matching was required.

15) What is the CFDA number and program area associated with this FOA?

The opportunity was in the health research category under CFDA 93.213, "Research and Training in Complementary and Integrative Health."

16) When was the FOA posted and what was the application acceptance window?

The FOA was posted on April 18, 2014, and it accepted applications through September 7, 2017. The archive date was October 8, 2017.

17) Is this FOA still active?

Based on the archive date provided (October 8, 2017) and the last date applications were accepted (September 7, 2017), this opportunity is archived and is not open for new applications under this announcement.

18) Who was eligible to apply?

Eligibility was broad and included many public, private, and nonprofit entities, along with small businesses and other for-profit organizations. The FOA also included extensive tribal eligibility and allowed certain foreign or regional organization participation (with reference to NCCAM special considerations for international interventional clinical studies).

19) What types of U.S. government or public entities were eligible?

Eligible public entities included state, county, city, township, and special district governments; public housing authorities and Indian housing authorities; and independent school districts.

20) Were institutions of higher education eligible?

Yes. Both public/state-controlled institutions of higher education and private institutions of higher education were eligible.

21) Were nonprofit organizations eligible, including those without 501(c)(3) status?

Yes. Nonprofit organizations were eligible whether or not they held 501(c)(3) status.

22) Were for-profit organizations eligible?

Yes. Both small businesses and other for-profit organizations (beyond small businesses) were included as eligible applicants.

23) What tribal entities were eligible?

Eligibility included federally recognized Native American tribal governments and other tribal organizations.

24) Were community-based and faith-based organizations eligible?

Yes. The FOA included eligibility for faith-based and community-based organizations.

25) Which mission-specific or minority-serving institutions were explicitly included?

The FOA explicitly included HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American and Native American Pacific Islander-Serving Institutions (AANAPISIs).

26) Could foreign organizations participate?

The FOA permitted certain non-U.S. participation through foreign organizations and regional organizations, and directed applicants to NCCAM's special considerations for international interventional clinical studies.

27) What would a strategically aligned project look like under this mechanism?

The announcement described this opportunity as appropriate for investigators who already have a plausible mind and body intervention and a defined clinical condition, but need targeted clinical trial evidence to justify and properly design a larger confirmatory study. Competitive projects would typically include concrete feasibility milestones, evidence supporting outcome selection or effect size estimation, proof the intervention can be delivered consistently, and a clear pathway to a later controlled study with potential public health importance.

28) Where can applicants find the original FOA?

The FOA provided an official NIH Grants link: http://grants.nih.gov/grants/guide/pa-files/PAR-14-182.html

29) Who should be contacted for technical issues accessing the FOA?

The announcement referenced NIH Office of Extramural Research (OER) webmaster contacts for technical access issues or broken links.