Regulatory Focus™ > News Articles > Legislation would Create New Incentives, Penalties to Compel Reporting of Trials Results

Legislation would Create New Incentives, Penalties to Compel Reporting of Trials Results

Posted 10 June 2013 | By

A new piece of legislation introduced in the US House of Representatives last week would require clinical trials to report their results to an existing registry maintained by US officials or risk losing both current and future funding.


At present, sponsors of clinical trials are responsible for making basic data available to the public through a database maintained by the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) known as

Under the FDA Amendments Act (FDAAA) of 2007, sponsors are also required to make "basic results" available for certain clinical trials, with most supposed to publish that information within a year after the trial's date of completion.

The problem, however, is that the requirement is often ignored by companies. In May 2012, the British Medical Journalreported that 78% of companies flouted the data reporting requirement, and even 50% of NIH-sponsored studies did not report results. Though FDA partially disputed the results, saying that some trials were exempted from requirements and that others had been given reporting extensions, it conceded that some sponsors had been negligent in their duties and announced that at least 15 would be investigated.

A similar problem was later flagged by another journal, Pediatrics, which noted that many companies were terminating or suspending trials, leading to a "substantial publication bias."

New Legislation

But if new legislation comes into effect, powerful incentives may lead to substantially increased rates of compliance, argue its sponsors. H.R. 2301, the Clinical Trial Cancer Mission 2020 Act, sponsored by Reps. Tom Reed, Louise Slaughter and Chris Collins, clarifies that clinical trial registry data bank requirements "apply regardless of trial outcomes."

That would, in theory, close a loophole by which some companies could shut down a trial if the outcome appeared to be negative.

"We are here today to make sure important clinical trial results are made available to all researchers so that we might improve care, increase the chances of finding a cure, and safeguard taxpayer dollars from funding redundant research," Reed said in a statement.

"Knowing if a clinical trial failed is just as important as knowing if a trial is successful so millions of dollars are not wasted by other researchers attempting the same research efforts," Reed continued. "It's vitally important all trial results are shared so that we might better understand the results to provide better care and advance our shared goal of finding a cure."

The bill also contains a powerful incentive for companies entities (i.e. grantees) to report, and especially those that rely on government funding. Any granteee that does not report the results of a trial within 30 days of the deadline date will not be eligible to receive any additional funding from a current grant, will be frozen out from receiving any future grants, and may even be required to repay any amount provided under the grant for the clinical trial for which the grantee failed to comply with such reporting requirements.

Clinical Trial Cancer Mission 2020 Act

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