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US proposes tighter rules on clinical trial reporting

If approved, data from around 650 additional studies per year will be released

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The ongoing debate over access to clinical trial data could expand beyond Europe and into the US now that the federal government has proposed new transparency rules.

The Department of Health and Human Services (DHHS) wants to increase the number of clinical trials that must have their results reported on the website, for example by expanding the requirement to include trials of unapproved products.

The National Institutes of Health (NIH) estimates that the proposals, if approved, would result in the release of data for about 650 additional studies each year. The deadline for comments is February 19 2015.

Now, any researcher receiving funding from the NIH will have to make their study results available on the site, with a deadline of one year after trial completion for summary data.

Summary data would include baseline characteristics of participants, primary and secondary outcome results and information about adverse events. This was not previously a requirement in the US and so researchers were at liberty not to report the results of an ineffective study, for instance.

"Unfortunately, the timely public reporting of results has not been consistent across the clinical trials enterprise," says NIH director Francis Collins in a blog post co-written by deputy director Kathy Hudson.

"A recent analysis of 400 US clinical trials found that even four years after the trials had been completed, nearly 30% had failed to share results," they note.

At the moment, only about 15,000 of the approximately 178,000 trials registered on include summaries of results.

"This proposed rule would close an important gap, making additional information about clinical studies of investigational drugs, medical devices and biological products available to the public," said FDA Commissioner Margaret Hamburg in a statement.

"It would help eliminate unnecessary duplicative trials, advance biomedical innovation, and provide the public with a much richer understanding about the clinical trials for these products," she added.

Some transparency advocates argue that the proposals do not go far enough. Kay Dickersin, director of the Center for Clinical Trials at the Johns Hopkins Bloomberg School of Public Health, told Reuters that "there are also disappointments" in the proposals particularly the lack of a requirement to reveal details of clinical trial protocols.

The NIH and DHHS summary says that it would like to hear comment from the public on the "advantages and disadvantages of including technical and non-technical summaries in and of requiring submission the full clinical trial protocol."

On this side of the Atlantic, access to clinical trial data remains a difficult topic, with the European Medicines Agency coming under dire last week over the redaction of clinical study reports (CSRs) for AbbVie's Humira (adalimumab).

The EMA revealed its policy on publishing clinical trial results last month, although transparency groups have concerns about the document, including the redactions process and a clause allowing direct legal action against researchers if they believe the Terms of Use clauses in data access contracts are breached.

Article by
Phil Taylor

20th November 2014

From: Regulatory



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