NCCIH Research Blog

• Do you have an important health care research question that can be answered in a real-world setting?
• Is it in a high-priority area for NCCIH pragmatic trials?
• Is the intervention already being utilized?
• Do you have experience conducting clinical research in partnership with health care systems?

If you answered yes to these questions, NCCIH has a funding opportunity for you! The NIH Collaboratory program has issued a new RFA for Demonstration Projects for Pragmatic Clinical Trials and NCCIH is participating.

What is the NIH Collaboratory?

The NIH Health Care Systems Research Collaboratory is an NIH Common Fund program. It has pioneered approaches for conducting large-scale, cost-effective randomized pragmatic trials in the health care settings where patients normally receive their care. Its trials are performed in real-world settings, and they leverage crucial partnerships to address questions that are important to patients, their care providers, as well as researchers. NCCIH and the National Institute on Aging have been leading the Collaboratory program. You can learn more about the Collaboratory and the concept of pragmatic trials in this blog post by our Director, Dr. Josephine Briggs.

NCCIH is participating in the Collaboratory’s new funding opportunity with 10 other NIH Institutes, Centers, and Offices, each of which is looking for applications that pose important health care research questions in its area of interest which can be addressed in real-world settings. NCCIH encourages all investigators who conduct clinical research within health care systems and who are ready to conduct a pragmatic trial on their research question to consider applying for this new opportunity.

Why Are Pragmatic Trials Important?

Pragmatic trials, sometimes called effectiveness trials, test interventions under conditions that are close to real-world settings – sometimes embedded in routine care. Efficacy trials, by contrast, test interventions under very specific and ideal conditions, usually not within routine care, and typically provide extensive follow-up. Efficacy trials also typically address whether interventions work and are safe in specific, sometimes narrow, groups of patients. If efficacy is established, follow up pragmatic trials then address whether interventions can practically be implemented on a large-scale to improve patient care. Pragmatic trials are a paradigm shift for clinical research, since they are performed in real world settings and have the goal of testing effectiveness of practical health care approaches for large groups of patients. Another important aspect of Collaboratory pragmatic trials is they use randomization as a key design feature. Randomization maximizes the scientific rigor of trial findings, providing good evidence that informs patient and provider decisions.

Is Your Research Question Ready for a Pragmatic Trial?

NCCIH realizes that complementary health approaches are being integrated into the care offered in nursing homes, hospices and hospitals; and many complementary approaches are readily available to the public. Patients, providers and researchers all want the best available clinical evidence to inform decisions about which approaches or therapies to provide or recommend. If you are considering a pragmatic trial design in one of our high priority areas, is there sufficient efficacy information on the intervention to warrant further testing in a large-scale pragmatic trial across your health care system? Also, if you’re interested in this specific funding opportunity, consider whether your intervention can readily be implemented across health care systems.

What Topic Areas Are High Priority for NCCIH Pragmatic Trials?

NCCIH is interested in symptom management, especially for chronic pain syndrome. The interventions to be studied must be mind and body or integrative approaches. Potential topics:

• Symptom management, especially for chronic pain syndromes
• Reduction of prescription drug (opioid) use or abuse in patients with chronic pain
• Medication adherence
• Post-traumatic stress (disorder)
• Traumatic brain injury
• Sleep disorders or disturbances
• Anxiety
• Depression
• Promotion of psychological resilience
• Weight loss and weight loss maintenance
• Smoking cessation
• Promotion of healthy eating and physical activity

When Do I Need to Apply?

Letters of intent are due on May 2, 2017, with an application receipt date of June 2, 2017.

If I Have More Questions, What Should I Do?

Contact me, Robin Boineau, M.D., at rb@nih.gov. You can also participate in our Webinar on this funding opportunity on Tuesday, April 25, 2017 from 2:30 to 3:30 p.m. ET.