On January 18, 2017, the final rule from the Department of Health and Human Services (HHS) and the National Institute of Health (NIH)’s corresponding policy on reporting to ClinicalTrials.gov will take effect. ClinicalTrials.gov, which is run by NIH, is a searchable registry of clinical trials. It is a federal requirement that sponsors of certain clinical studies that either have one American research site or are conducted under an investigational device exemption (IDE) or an investigational new drug (IND) application register and report the summary results on ClinicalTrials.gov. However, currently very few pharmaceutical companies, academic institutions, and government agencies are complying with the requirement. The regulatory changes taking effect will only have a meaningful impact if the incoming Administration chooses to enforce them.
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