HHS final rule seeks to boost transparency of clinical trial data

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Drug researchers will soon be required to submit information and data from clinical trials to an online database per a new final rule from HHS seeking to improve public access to information about drugs, biological products and devices regulated by the U.S. Food and Drug Administration.

The final rule, published Friday, requires there to be one "responsible party" who must submit information about applicable clinical trials to ClinicalTrials.gov. Responsible parties must register clinical trials within 21 calendar days of enrolling the first human participant in the trial, and certain data elements and clinical trial information must be included with that registration. Data elements include descriptive information, recruitment information, location and contact information and administrative data elements.

Additionally, the responsible party must submit information regarding any adverse events, summary results of the trial, corrections to errors discovered during quality control review of information and other data.

According to the National Institutes of Health, expanding the information available in ClinicalTrials.gov will help people find trials in which they may be able to participate and help inform providers about medical decisions. What's more, NIH indicates the information will help avoid duplicate trials and improve study design.

The new rules apply to most interventional studies of drug, biological and device products regulated by the FDA.

"When people participate in clinical trials, they are volunteering to create generalizable knowledge to help others in the future, and we want their participation honored by ensuring that the existence of trials and their results are available to all patients and their healthcare providers, as well as researchers," said Robert Califf, MD, FDA commissioner, in a statement.  

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