By Admin at 21 Oct 2016, 14:29 PM

New initiatives released by the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services (HHS) will help to make clinical trial data increasingly available to the public.

Clinical trials are a crucial part of cancer research, helping to increase knowledge about the disease and develop new forms of prevention and treatment. However, in order for clinical trials to best serve the scientific community and the public, their results must be shared quickly and made available in an easily accessible format.

The HHS Final Rule adds new requirements for registering and submitting summary results information to ClinicalTrials.gov, a registry and results database of clinical studies involving human participants.

The NIH policy is complementary to the HHS Final Rule and applies to all NIH-funded clinical trials, including those that may not be subject to the HHS Final Rule. Key requirements of the Final Rule include:

• Applicable clinical trials be registered at ClinicalTrials.gov no later than 21 days after the first participant is enrolled
  
  
• If a drug or biological product that’s being investigated is available to patients under expanded access, this must be explained in a separate expanded access record (including sharing details about how patients may obtain the drug)
  
  
• The results of all applicable clinical trials must be shared no later than one year after the primary completion date of the study (currently, results are only required to be submitted if the drug or other product being investigated has been approved by the U.S. Food and Drug Administration (FDA))
  
  
• All submitted information must be updated at least once a year and more frequently in some cases to ensure data stays up-to-date and accurate

 
Drs. Kathy L. Hudson and Francis S. Collins explained on the NIH Director’s blog that the new initiatives will pave the way for increased access to potentially life-saving clinical trial data:

“ClinicalTrials.gov contains a treasure trove of information, and the value of this information will continue to grow as more studies are added when investigators and institutions follow the new rules.

We need to make this information easily accessible to patients and those who love and care for them. If your daughter, sister, or father is sick and out of options, it should be simple and intuitive to search for clinical trials that may be relevant.”

NIH’s National Library of Medicine (NLM), which manages ClinicalTrials.gov, also has plans to work with IT experts to make the site more user-friendly so it’s simple and intuitive for patients, family members, health care providers and researchers to access valuable information about clinical trials and their results.

Sources
National Institutes of Health September 15, 2016
National Institutes of Health September 16, 2016

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