NCCIH Research Blog

As health care and health interventions increasingly shift to remote forms of delivery, the National Center for Complementary and Integrative Health (NCCIH) recently published PAR-20-154 to support Investigator Initiated Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (R01 Clinical Trial Required). This blog post describes the unique features of this new funding opportunity announcement (FOA).

What is a “remotely delivered” intervention? For the purposes of this FOA, a remotely delivered intervention is one with no in-person contact between participants and research staff. This means that all aspects of the research design, including recruitment, randomization, intervention delivery, data collection, and safety monitoring, must be done remotely.

Remotely delivered and mobile health (mHealth) interventions may use mail, email, telephone, mobile apps, video, web-based platforms, wearable devices, and other modern technologies. Research on natural products interventions and mind and body approaches will be supported.

What are the research objectives of PAR-20-154? This FOA is intended to support fully powered efficacy, effectiveness, or pragmatic trials of remotely delivered complementary and integrative health interventions for a range of health outcomes including symptom management (e.g., chronic pain, sleep disorders, anxiety, depression, posttraumatic stress), medication adherence, and health promotion (e.g., resilience, healthy eating, physical activity promotion, smoking cessation).

What preliminary data are required? Preliminary data requirements are detailed in the FOA. Most importantly, investigators should have data from previous studies on the specific intervention utilizing the same remote delivery mode and in the same population that demonstrates the feasibility and safety of their proposed intervention and provides justification for the delivery format and dose of the intervention. For studies proposing a natural product intervention, there must be evidence that the product produces a clinically meaningful change in a biological signature, data that correlate the biological signature with clinical outcomes, and pharmacokinetic data to justify dosing and safety of the product.

What if I don’t have preliminary data yet? If you do not yet have the required preliminary data, you should first conduct early phase clinical trials to determine the feasibility and acceptability of your approach.

For more information about what NCCIH recommends for the multistage process for intervention development and testing and relevant FOAs to support this work, visit the NCCIH webpage on clinical trial funding.

We hope you will consider applying to this exciting new opportunity to test remotely delivered complementary and integrative health interventions! The next round of applications to PAR-20-154 is due on October 5, 2020. Please contact me at lanay.mudd@nih.gov for feedback on your concept well before the application due date.