NIH Resources for Conducting Clinical Trials

*New* Clinical Trials Resources

National Institutes of Health's definition of a clinical trial: https://grants.nih.gov/policy/clinical-trials/definition.htm

In 2016, NIH launched a multi-faceted effort to enhance its stewardship over clinical trials. The goal of this effort is to encourage advances in the design, conduct, and oversight of clinical trials while elevating the entire biomedical research enterprise to a new level of transparency and accountability. The NIH definition of a clinical trial was revised in 2014 in anticipation of these stewardship reforms to ensure a clear and responsive definition of a clinical trial. Learn more about why NIH has made changes to improve clinical trial stewardship.

Diagram courtesy: National Institutes of Health

 

 

 

 

 

 

 

 

 

 

 

 

 

 

This page provides information, tools, and resources about the definition of a clinical trial. Correctly identifying whether a study is considered by NIH to be a clinical trial is crucial to how you will:

  • Select the right NIH funding opportunity announcement for your research study
  • Write the research strategy and human subjects sections of your grant application and contact proposal
  • Comply with appropriate policies and regulations, including registration and reporting in ClinicalTrials.gov

Background

In 2016, NIH launched a multi-faceted effort to enhance its stewardship over clinical trials. The goal of this effort is to encourage advances in the design, conduct, and oversight of clinical trials while elevating the entire biomedical research enterprise to a new level of transparency and accountability. The NIH definition of a clinical trial was revised in 2014 in anticipation of these stewardship reforms to ensure a clear and responsive definition of a clinical trial. Learn more about why NIH has made changes to improve clinical trial stewardship.

Updates from NCMRR

Dr. Alison Cernich, Director of the National Center for Medical Rehabilitation Research (NCMRR) in the National Institute of Child Health and Human Development (NICDHD), recently updated MR3 Network members with these new important crinical trials resources.

  1. NIH is launching a series of initiatives that are rolling out in 2017-2018 to enhance the accountability and transparency of clinical research. These initiatives target key points along the whole clinical trial lifecycle from concept to results reporting.
    • Learn about the changes and how they will affect your research.
    • Learn about clinical trial-specific funding opportunities.
    • Learn about the steps to compliance for NIH grantees.
  2. NIH has launched the Next Generation Researchers Initiative to address longstanding challenges faced by researchers trying to embark upon and sustain independent research careers, and to take steps to promote the growth, stability and diversity of the biomedical research workforce.
  3. Upcoming deadline on FOI in cardiovascular rehabilitation
  4. Summits Accessible by Videocast and Upcoming
    • Care Giving Summit hosted by NINR in August, 2017 (webcast) Learn more.
    • The 2018 Physical Activity Guidelines Advisory Committee of the Office of Disease Prevention and Health promotion (ODPHP) will convene its fifth and final public meeting October 17-20, 2017. You can attend the meeting online via videocast. Learn more.

As Director of NCMRR, Dr. Cernich oversees a varied portfolio of research projects, training programs, and rehabilitation research infrastructure network sites aimed at improving the care of individuals with physical disability who require medical rehabilitation.

Federal Rules and Requirements for Clinical Trials

Clinical Trials Toolkits from the NIH

National Institute of Dental and Cranialfacial Research (NIDCR):  https://www.nidcr.nih.gov/Research/toolkit/ 

National Center for Complementary and Integrative Health (NCCIH):  https://nccih.nih.gov/grants/toolbox 

Office of Science Policy:  http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials