Fwd: ClinicalTrials.gov Registration and Reporting: A Looming Crisis

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So much to UNCOVER About PEG!Subject: ClinicalTrials.gov Registration and Reporting: A Looming CrisisFDAnews Management Report

Registering and Reporting Trial Data on ClinicalTrials.gov

A Drugmaker's Compliance Guide

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A January 2012 study published in the British Journal of Medicine revealed only 22% of drug trial sponsors actually complied with requirements to report trial results on ClinicalTrials.gov.

Consequently, Congress has started investigations into WHY penalties have not been assessed for non-reporting to ClinicalTrials.gov — and WHY government agencies haven't stayed on top of the reporting requirements.

And now there's pending legislation in the House of Representatives that would even increase reporting requirements and also step up penalties.

The Agencies Coming Under Scrutiny:

The NIH oversees the site and has not implemented the latest phases of the ClinicalTrials.gov mandate to incorporate greater adverse event reporting and expanded trials data into the site.

The FDA is charged with overseeing compliance of the clinical trials reporting requirements. And, under existing law, they could have charged non-compliant sponsors up to $10,000 a day!

While the FDA has not actively enforced these requirements, pressure is building and the enforcement hammer could drop on thousands of trials conducted since 2007. Would yours be one of them?