US issues final rules for clinical trial information reporting

By Stewart Eisenhart, Emergo Group

EMERGO SUMMARY OF KEY POINTS:

• A final rule from the US Department of Health and Human Services (HHS) expands clinical trial reporting requirements to the ClinicalTrials.gov website.
• To complement the HHS rule, the National Institutes of Health (NIH) is also increasing clinical trial reporting requirements for medical device and drug studies it funds.
• The HHS final rule is effective in January 2017.

The US Department of Health and Human Services (HHS) has overhauled submission and reporting requirements for clinical trials involving medical devices, drugs and related products in an effort to boost accessibility of such information to the public.

HHS and the Food and Drug Administration have increased requirements for clinical trial registration information, which US regulators make available via the ClinicalTrials.gov website; in a coordinated effort, the US National Institutes of Health has also introduced a new policy pertaining to registration and submission of clinical trial summary results to ClinicalTrials.gov for all trials funded by that entity.

The new requirements come into force January 18, 2017.

Among the final rule’s components and requirements are:

• Checklists for determining which types of clinical trials fall under the final rule
• A broader scope of clinical trials requiring summary results data; devices and other products regulated but not yet cleared or approved by the agency are now included under this scope
• Requirements for more types of adverse event information
• A clear explanation of legal consequences and penalties for non-compliance with the final rule

Explaining the decision to expand ClinicalTrials.gov submission and related requirements under the final rule, HHS and the NIH stated, “More information about the scientific results of trials, whether positive or negative, may help inform healthcare providers and patients regarding medical decisions. Additional information will help researchers avoid unnecessary duplication of studies, focus on areas in need of study and improve study designs, ultimately advancing the development of clinical interventions.”

The new US clinical trial reporting requirements come into force January 18, 2017.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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