Unpublished Trial Data Spur Further Debate

Laird Harrison

July 12, 2013

Should previously undisclosed data from unpublished or misreported clinical trials become publicly available? Writers on both sides of the issue articulate their arguments in duelling editorials published online July 9 in the BMJ.

In one editorial, Ben Goldacre, MRCPsych, a research fellow at the London School of Hygiene and Tropical Medicine in the United Kingdom, argues that publishing the data will lead to better decisions about drugs.

In the other editorial, John Castellani, president of the Pharmaceutical Research and Manufacturers of America, argues that mandatory disclosure could violate patients' privacy and allow competitors or unscrupulous actors to misuse the information.

The debate comes as new freedom of information policies and lawsuits have produced a trove of clinical study reports, documents held by researchers and regulators that contain the results of trials. Activist researchers are threatening to reveal the data if the original authors do not commit to publishing it themselves.

Many of the activists have joined in a campaign, AllTrials, calling for all trials to be registered and for the results to be published, and in February GlaxoSmithKline announced its support for the campaign.

However, some other drug companies are resisting the call.

"Overall, the lack of progress on transparency has been startling," Dr. Goldacre writes. Half of all trials for the treatments being used today have not been published, and two thirds of those published show positive results, he says.

Disclosing the data to regulators alone is not sufficient because more eyes are needed to catch problems, Dr. Goldacre argues. He cites problems with rofecoxib (Vioxx, Merck) and rosiglitazone (Avandia, GlaxoSmithKline), which he says regulators overlooked until academics and clinicians began to notice them.

Attempts to address the problem so far have failed, Dr. Goldacre continues. For example, he cites estimates that only 60% to 90% of trials have been published, indicating that researchers have not complied with US legislation passed in 2007 requiring all trials since 2008 to post results on Clinicaltrials.gov within a year of completion.

In addition, he says, older data could improve our understanding of many medicines now on the market, and even data on paper could be scanned and published.

Sensitive personal information could be deleted before the data is published or shared with only selective researchers, says Dr. Goldacre.

In contrast, Castellani argues that patients could become reluctant to participate in clinical trials if they fear that any such personal details could be disclosed.

"The biopharmaceutical industry is firmly committed to enhancing public health through responsible reporting and publication of clinical research and safety information," he writes.

However, mandatory public disclosure of clinical trial information without appropriate scientific and clinical context could also undermine trust and confidence in the safety and effectiveness of approved medicines, Castellani writes.

He also raises concerns over disclosure of intellectual property. If pharmaceutical companies know that confidential commercial information and proprietary scientific methods found in clinical trials will be disclosed, this "could stifle discovery and open the possibility of competitors or unscrupulous actors using the information for their own products in other markets or countries."

Dr. Goldacre's research fellowship in epidemiology is funded by the Wellcome Trust. Castellani has disclosed no relevant financial relationships.

BMJ. Published online July 9, 2013. Goldacre full text, Castellani full text

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