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NCCIH 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.

Catherine M. Meyers, M.D.
Catherine Meyers, M.D
October 04, 2019

If you are a current or prospective clinical researcher, I think you’ll be interested to know that NCCIH recently added two new protocol templates to the Clinical Research Toolbox, our web-based information repository for investigators and staff involved in NCCIH-funded clinical research.

The Toolbox already includes a protocol template recommended for NCCIH-funded studies. The new templates provide additional protocol strategies that you can use for specific kinds of NCCIH-funded trials:

  • Phase 2/3 clinical protocols 
  • Behavioral and social sciences research.

Phase 2/3 Clinical Protocols 

To facilitate the development of clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) application, NIH and the FDA worked together to develop a Phase 2/3 Clinical Trial Protocol Template. It is intended to help you think through the scientific basis of your assumptions, minimize uncertainty in the interpretation of outcomes, and prevent loss of data. This template is optional for NIH-funded phase 2 and 3 trials conducted under an IND or IDE application. Having a common protocol structure and organization eases the way for protocol review by oversight entities. 

Behavioral and Social Sciences Research

The second new template is designed to support communication of the science, methods, and operations of a clinical trial in behavioral and social sciences research; efficient review by peers and oversight bodies; and reporting of related information into ClinicalTrials.gov. Other benefits of using a standardized template include helping to guide the replication of studies, and adherence to the International Conference on Harmonisation E6 Good Clinical Practice guidelines. I think that this template will be especially helpful if you are in the process of learning about the information and level of detail expected in a clinical protocol. 

More Toolbox Resources

Overall, the Toolbox offers an array of templates, sample forms, guidelines, regulations, and other informational materials to help clinical investigators develop and conduct high-quality clinical studies. As you peruse it, you will notice that there are many resources for your study team as you prepare for study startup and implementation. We regularly update these offerings to keep up with changes in clinical research requirements.

The Toolbox is a popular part of our website, and we hope it will continue to help researchers. While we encourage you to use the templates, they are not required for NIH applications or contract proposals. If you have a comment about the Toolbox, please feel free to submit it below. 

Craig Hopp, Ph.D.
September 25, 2019
Craig Hopp, Ph.D.

In this blog post, NCCIH’s Dr, Craig Hopp calls attention to two new requests for applications (RFAs) related to natural products research.

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Emmeline Edwards, Ph.D.
September 17, 2019
Emmeline Edwards, Ph.D.

In this blog post NCCIH’s Dr. Emmeline Edwards discusses a new evidence-based consensus study report cosponsored by NCCIH: Fostering Healthy Mental, Emotional, and Behavioral Development in Children and Youth. 

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Partap S. Khalsa, D.C., Ph.D.
September 12, 2019
Partap S. Khalsa, D.C., Ph.D.

In this blog post Dr. Partap Khalsa announces topics to be discussed at the upcoming session of NCCIH’s National Advisory Council on Friday, Sept. 20, 2019.

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Langavin
September 09, 2019
Helene Langevin, M.D.

In this blog post, NCCIH Director Dr. Helene Langevin spotlights the keynote presentation on pain by Dr. Lorimer Moseley at the upcoming 20th anniversary symposium.

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Emmeline Edwards, Ph.D.
August 28, 2019
Emmeline Edwards, Ph.D.

In this blog post, NCCIH’s Dr. Emmeline Edwards discusses NIH’s High-Risk, High Rewards Research Awards.

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This page last modified March 20, 2019