ClinicalTrials.gov Updated – Proposed Rule would have Clinical Trial Results Reported, even when Product isn’t Approved

The US Department of Health and Human Services Department (DHHS) proposed a new rule with respect to Clinical Trial Registration and Results Submission. This proposed rule has a commenting period that end in 84 days (02/19/2015).

The purpose of the proposed rule is to establish requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drugs (including biological products), devices and for pediatric postmarket surveillance of a device to ClinicalTrials.gov.

One of the important proposals is the statutory requirement for the submission of summary results information for applicable clinical trials of drugs, biological products, and devices that are approved, licensed, or cleared by FDA. It also proposes to extend the requirement for results submission to applicable clinical trials of drugs, biological products, and devices that are not approved, licensed or cleared by FDA. Importantly, the new proposed rule will see only one entity, the sponsor unless “the sponsor designates a qualified principal investigator,” responsible for submitting information regarding the clinical trial.

“The proposed rule would require the submission of results no later than 1 year after the completion date of the clinical trial, which is defined as the date of final data collection for the primary outcome measure studied.”

The complete proposed rule can be accessed here:
https://www.federalregister.gov/articles/2014/11/21/2014-26197/clinical-trials-registration-and-results-submission?utm_campaign=pi+subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov#h-8

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