Clinicaltrials.gov Expansion

Zarin and Tse (from NLM) have published in Science a thoughtful commentary, Moving Toward Transparency of Clinical Trials, in which they discuss problems of reporting bias against negative trials and review Section 801 of the FDA Amendments Act (“FDAAA 801”), which was enacted on Sept 27, 2007 and “expands the scope of required registrations at ClinicalTrials.gov and provides for the first federally funded trial results database. It mandates registration of a set of controlled clinical investigations, other than phase I trials, of drugs, biologics, and devices subject to regulation by the FDA. The law applies to research for any condition regardless of sponsor type (e.g., industry, government, or academic).”

This is a massive undertaking of great import, and they conclude that “FDAAA 801 should transform the degree of public access to critical clinical trial information from publicly and privately funded clinical research” but also discuss several challenges to its implementation related to potential loopholes and issues of IP, validation, and interpretation by the public. For example, the “NIH and FDA are directed by the law to conduct a pilot quality-control project to determine the optimal method of verification” of the completeness and accuracy of submitted data. Whoa. And double whoa when it comes to balancing the need to protect IP while also protecting and promoting public health (particularly those who volunteer to participate in clinical research). Stay tuned.

1 Comment »

  1. […] the FDA Amendments Act of 2007 has set in motion the expansion of clinicaltrials.gov to include compulsory reporting of basic results. You can check out progress made on the basic […]

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