National Center for Complementary and Integrative Health (NCCIH)

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N C C A M Research Blog

NCCIH Research Blog

NCCIH blogs about research developments related to complementary health practices. Check in regularly to keep up with the latest findings.

Wendy Weber, N.D., Ph.D., M.P.H.
March 24, 2015
Wendy J. Weber, N.D., Ph.D., M.P.H.

Which funding mechanism should be used for early stages of clinical research? As Chief of the Clinical Research in Complementary and Integrative Health Branch and formerly a Program Director, I've spoken to many investigators about choosing an appropriate funding mechanism for a proposed clinical study. I've also seen applications for mind and body clinical research that, unfortunately, lack critical preliminary data. Often, I'll encourage investigators to make a list of the preliminary data that would help them design a future efficacy or effectiveness trial. Once they have this list, they can prioritize and identify the most important issues that need to be addressed. Sometimes, the R34 is just the right grant program to assist researchers gather the data they need. 

I would like to share NCCIH’s Framework for Developing and Testing Mind and Body Interventions— and show you how it relates to the R34 planning grant.

The framework consists of six major stages that apply to mind and body clinical research and are graphically represented by six colored circles:

Full text description available from following link.
[text version]

In the orange circle (i.e., the first stage), the question being addressed is whether the intervention of interest can demonstrate a biologically and/or clinically meaningful and measurable effect when employed. Often, our Program Directors hear from investigators who have conducted a small pilot study at this stage (such as a case series, controlled or uncontrolled, with 10 to 20 participants). The researchers have performed a pre- and post-analysis, and have found a clinically meaningful signal.

Investigators sometimes want to make the leap to apply for a study in the blue or red circles (i.e., an efficacy study with appropriate comparison, or an effectiveness/comparative-effectiveness study) without first having conducted research in the yellow and green circles (respectively: intervention development, refinement, and standardization; and feasibility and pilot studies). This leap to the efficacy/effectiveness stage can have unintended consequences of conducting an inadequately powered study with an intervention that has not been refined for study and in a population that may not include those most responsive to the intervention.

The framework has an important relationship to NCCIH’s current R34 opportunity, Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics, as follows:

  • The R34 is designed to support work in the yellow and green circles.
  • It is ideally positioned for researchers who have done a small pilot study that demonstrates a signal that an intervention may have benefit for a particular condition. Yet, additional data is needed to justify the design choices for the future clinical trial.
  • If this is your situation, it is good to think about how you would design an eventual, larger-scale effectiveness or efficacy study. In order to maximize your chances of being able to recruit and complete that future definitive study, consider conducting an additional study using the R34 mechanism.

What are some advantages of using the R34 funding opportunity?

  • You can obtain data critical for planning and defining a subsequent, full-scale clinical trial.
  • You can obtain data useful in filling gaps in scientific knowledge and necessary for a trial to be competitive.
  • You can further refine and develop the intervention to be sure you are delivering it in a way that will have high adherence and will be of sufficient duration to have an impact. This may require assessing how often and how long the intervention should be delivered. If appropriate, you can also assure that the intervention can be delivered with fidelity by a variety of well-trained instructors.
  • You can develop and test which comparison conditions are most acceptable and have similar retention and adherence as the test intervention.
  • If the future clinical trial would require a large sample size, you may need multiple sites. You could propose an R34 to pilot-test the intervention at multiple sites, demonstrating recruitment, data collection, and fidelity across the sites.
  • You will be able to demonstrate that the intervention is being studied in the right population, and is being delivered in the way most likely to obtain the best adherence, retention, and participation. You will also be able to demonstrate your team’s ability to recruit and retain participants representing those who have the condition under study.

I encourage you to consider the various stages of clinical trials research and use of the R34 mechanism. NCCIH Program Directors are available to discuss your research interests, questions, and approaches. They can also advise you on available or appropriate funding mechanisms for your research.

March 12, 2015
Emmeline Edwards, Ph.D.
Portrait of Dr. Edwards

Dr. Emmeline Edwards, Director of NCCIH’s Division of Extramural Research, discusses the recent Third National Summit: Advancing Research in the Arts for Health and Well-being Across the Military Continuum in this blog post.

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February 11, 2015
Josephine P. Briggs, M.D.
Josephine P. Briggs, M.D.

In this blog post, NCCIH Director Dr. Josephine Briggs discusses a report from a working group of NCCIH’s Advisory Council that recommends large-scale collaborative pain research to benefit military personnel and veterans.

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December 15, 2014
NCCAM Blog Team

Lucy Bauer holds a Post-Baccalaureate Intramural Research Training Award (IRTA) position at NCCAM. Last week on the NIH's “I Am Intramural” blog, she shared her experience as an NIH postbac.

Learn more about applying to the NIH Postbac IRTA Program, which gives recent college graduates who are planning to apply to graduate or professional school a chance to train at the NIH for one or two years.

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December 12, 2014
Josephine P. Briggs, M.D.
Josephine P. Briggs, M.D.

This blog post by NCCAM Director Dr. Josephine Briggs presents a video clip about new research standards for low-back pain.

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December 04, 2014
NCCAM Blog Team

A new workshop summary that describes research needs on the interaction between sleep and pain is discussed in this blog post.

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