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Update on Clinical Trials Oversight

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November 14, 2014
David Shurtleff, Ph.D.
David Shurtleff, Ph.D.

Deputy Director
National Center for Complementary and Alternative Medicine

View Dr. Shurtleff's biographical sketch

I have an exciting development to report about NCCAM’s extramural research: we are modifying our oversight process for clinical trials.

NCCAM has a diverse portfolio of grants in clinical research, from randomized clinical trials to observational, epidemiological studies and small-scale, laboratory-based mechanistic research. All fit with the goal of better understanding “real world” patterns of outcomes when complementary and integrative approaches are used, and their roles in health care and health promotion.

Clinical research requires great care, oversight, and monitoring. This helps minimize risks to the participants, ensure the integrity and validity of the data, and maximize the success, impact, and scientific potential of studies. In appreciation for this very important, complex process, NCCAM's Division of Extramural Research (DER) and the Office of Clinical and Regulatory Affairs (OCRA), working with extramural study teams, adopted  thorough pre-award assessment and post-award monitoring of our clinical research. The NCCAM Clinical Research Toolbox is a key part of this endeavor.

About a year ago, I began meeting with OCRA and DER staff to explore whether there were ways we could potentially modify and streamline this oversight and monitoring process to better serve our extramural clinical research community. We identified some feasible changes which will implemented at the Center this fall. 

Along this road, we have been gratified to hear feedback from the NIH community and from investigators that NCCAM maintains a high-quality standard of oversight. While seen by some as relatively rigorous, we think that it has many benefits.

The changes should help accelerate the pace of investigation, discovery, and, ultimately, development of new and effective treatments. We think that they will also:

  • Maximize participant safety in and scientific rigor of NCCAM clinical research
  • Strengthen and streamline NCCAM’s pre-award assessment processes
  • Improve communication between the Center and clinical research investigators
  • Reduce burden and increase efficiency
  • Raise confidence that resulting trial data will be of high quality
  • Support reproducibility
  • Lower costs—e.g., by enhancing trial enrollment and retention and supporting more timely trial completion; this, in turn, may also aid timely publication
  • Inform decisions concerning future research questions and the optimal designs for clinical trials.

I hope that NCCAM's research community will find this to be good news, and continue to share questions and feedback.

Comments

Comments are now closed for this post.

Dr. Shurtleff, I think this a huge step in the righ direction as more needs to be done for advancing all avenues of alternative medicine practices. I work for a small HIPAA healthcare compliance firm that deals direclty with Protected Health Information (PHI), and we are working now with more alternative practices then ever before regarding compliance measures. It just means alternative is becoming mainstream, which is great. I’m also seeing more and more insurance companies showing a more favorable light to alternative medicine, which is essential for the aging geriatric population i the U.S. My father is an MD and has practiced alternative medicine since the 1970s, has strongly belived in the concept, so I hope it continues.  Heather 

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From reading that post, I could see the stated benefits for the changes. However, I couldn’t find any details on what is actually changing. Is something missing? Thanks.

This is a wonderful initiative.  May it succeed fully.  

Dr. Danhauer, Thank you for your comment about the post. The changes we are making to NCCAM’s oversight process for clinical projects are virtually all internal—e.g., in the form of streamlining some administrative steps and internal communications about clinical studies that we support.  As described in the post, the overall goal is to better serve participants and the research community. For specific questions about the new process, we encourage researchers to speak with their NCCAM Program Director.

This page last modified February 12, 2016