Congress “Outraged” at Reporting Rate on Clinicaltrials.Gov
The FDA Amendments Act of 2007 (FDAAA) requires clinical trial sponsors to register certain clinical trials and disclose certain results on a publicly available website, clinical trials.gov. The drug trials Congress included in FDAAA were “controlled clinical investigations” that were conducted under an IND or would otherwise require an NDA or BLA to be licensed in the United States. Congress exempted Phase I studies from the requirements. The device trials Congress included were any “prospective clinical study of health outcomes comparing an intervention with a devices . . . against a control in human subjects.”
Sponsors have been diligently registering and disclosing data ever since, trying to overcome the backlog of eligible trials. As of today, Clinicaltrials.gov contains 145,553 studies with locations in all 50 states and in 185 countries.
But Congress says that’s not good enough. On May 16, 2013, Rep. Henry Waxman (D-Cal.) introduced a bill that would require sponsors to disclose Phase I studies, even though sponsors conduct dozens of short Phase I studies before going into the clinic and even though most Phase I studies aren’t controlled and don’t measure health or safety outcomes.
The bill also specifies that foreign trials are covered under the original rules. Sponsors already knew that and have been posting any foreign trial conducted as part of an IND — the fact that the database currently contains trials from 185 countries shows just how diligent the sponsors have been.
But Congress has latched on to a British Medical Journal study showing that only 22 percent of clinical trials are posted. The irony? It’s the federal government that is falling short. The government, including the National Institutes of Health, has posted only 8 percent of eligible clinical trials. Industry, on the other hand, has posted upwards of 40 percent.
Has the NIH clinical trial staff been sequestered?