NCCIH Research Blog

The Clinical Research in Complementary and Integrative Health Branch is excited to announce the release of updated funding opportunity announcements (FOAs), which will support the development and testing of mind and body interventions relevant to the new National Center for Complementary and Integrative Health (NCCIH) strategic plan. The updates were made to 1) streamline the timeline of clinical trials; 2) decrease repetitive single-site feasibility trials; and 3) prioritize impactful, fully powered efficacy and effectiveness trials. We know that many of our researchers have been eagerly awaiting the reissue of these FOAs.    

NCCIH will host an informational webinar about the updated FOAs on August 5, 2021, from 2–3 p.m. ET. We hope you will register to join us and learn more about the FOAs and what has changed.

Here is a summary of some of the key updates to the R34, R01 (formerly U01), UG3/UH3, and U24 FOAs:

Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 Clinical Trial Required) (grants.nih.gov/grants/guide/pa-files/PAR-21-240.html)

• This FOA will support single-site feasibility trials when there is no published feasibility research on a similar intervention in a similar population. Investigators need to justify that feasibility research they propose is needed and has not already been conducted or published.
• Examples of trials that may fit this FOA include 1) substantial adaptation or tailoring of an intervention when it is justified; 2) standardization of a treatment protocol and assessment of the feasibility of a multicomponent intervention; or 3) feasibility testing of strategies to inform the design of pragmatic or implementation studies.

NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required) (grants.nih.gov/grants/guide/pa-files/PAR-21-241.html)

• Mechanism changed from cooperative agreement (U01) to grant (R01).
• This FOA will support multi-site feasibility trials to demonstrate the teams’ ability to achieve fidelity, adherence, recruitment, and data collection across sites when there is no published multi-site feasibility research on the same or similar intervention in the same or similar population.
• Preliminary data requirements have changed to allow applicants to cite data from the literature about single-site feasibility for the same or similar intervention in the same or similar patient population. Preliminary data can now include the collective investigator team experience conducting trials with similar interventions and similar patient populations.
• Applicants are highly encouraged to keep study duration to 3 years or less and budget at or below $350,000 direct costs per year. NCCIH can reduce the duration and budget of awards if they are not extremely well justified to exceed these recommendations.

Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required) (grants.nih.gov/grants/guide/pa-files/PAR-21-243.html) with companion Data Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 Clinical Trial Required) (grants.nih.gov/grants/guide/pa-files/PAR-21-242.html)

• Continued requirement for multi-site trials to include both Clinical Coordinating Center (UG3/UH3) application and independent Data Coordinating Center (U24) application.
• Clarified requirements for sites to include at least three geographically distinct sites to enhance generalizability; and trials must be designed with 90 percent power for the primary aim.
• Preliminary data requirements have changed to allow applicants to cite data from the literature about multi-site feasibility for a similar intervention in a similar patient population. Preliminary data can now include the collective investigator team experience conducting multi-site trials with similar interventions and similar patient populations.
• The UG3 planning phase can now include a vanguard/pilot study when justified.