Bayer to Share Clinical Trial Data Amid Push for Transparency
Amid an ongoing push for more transparency, Bayer Healthcare has agreed to share some patient-level clinical trial data, provided that the test subjects’ anonymity is maintained.
Bayer has agreed to join ClinicalStudyDataRequest.com, which will allow researchers to request anonymous patient-level data, the site recently announced.
The decision comes as European regulators push companies for more transparency in their clinical trials. Last year, officials from the European Medicines Agency (EMA) published a draft policy that would require patient-level data submitted to the EMA by drug companies and other researchers to be made accessible to the public. The FDA has supported the move in the U.S. as well.
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The proposal initially met with resistance from the pharmaceutical industry, with some drug companies saying that such a move could compromise patient anonymity and would allow competitors to access company trade secrets and proprietary information. Some drug manufacturers hope that by voluntarily releasing some patient-level information voluntarily they can head off more sweeping government requirements in Europe and the U.S.
Bayer’s sponsor specific information on the website indicates that it will release information that includes trial data for products approved by both the FDA and EMA on or after January 1, 2014, or for products approved by one agency that are not part of an ongoing review or planned submission to the other agency.
The company did include some exceptions, saying it will not share data where there is a reasonable likelihood that an individual patient could be re-identified due to situations like rare diseases, single-center clinical studies, or clinical studies with a very small population. The company said it also may not be able to share data in cases where there are practical technical limitations, such a the size of databases from genetic studies.
The company also warned that it will not share data where there are legal, contractual or consent provisions restricting the data from release to third parties or in cases of substantial conflicts of interest.
From this month forward, the company said it will begin asking patients permission to make their data anonymous, so that they can give full informed consent when participating in the company’s clinical trials.
The integrity of industry clinical trial data has come under fire in recent years in the wake of a number of incidents regarding claims of ghost-writing and deliberate hiding or downplaying of drug risks and side effects.
In 2012, a congressional investigation determined that Medtronic paid $210 million to study authors that failed to include data on complications linked to its Infuse bone growth product in their reports. Those authors not only failed to disclose links to Medtronic, but the investigation also determined that Medtronic employees secretly edited and sometimes wrote parts of the studies before they were published, which encouraged the off-label use of Infuse.
Medtronic has faced hundreds of lawsuits over Infuse complications. Earlier this month the company announced that it had agreed to pay $22 million to settle about 950 Infuse lawsuits. However, the settlement leaves about 750 cases unresolved.
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