European Regulators Call for Drug Companies to Release Clinical Trial Data

A recent editorial written by experts from the European Medicines Agency (EMA) calls for drug companies to publicly release all patient-level clinical trial data, which they indicate would help protect public health and diminish distrust in industry-sponsored studies.  

The perspective piece was published in the New England Journal of Medicine on October 21. The experts from the EMA who wrote the editorial recently published a draft policy (PDF) that would require patient-level data submitted to the EMA by drug companies and other researchers be made accessible to the public. The FDA has made similar proposals.

According to the editorial, drug companies are worried that the patient-level trial data, more specific than what is usually released when clinical trials are published, would allow competitors to access company trade secrets and proprietary information. However, the EMA argues that full transparency, with patient identities protected, would benefit drug developers.

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“Contrary to industry fears, we argue that access to full — though appropriately deidentified — data sets from clinical trials will benefit the research-based biopharmaceutical industry,” they wrote. “We predict that it will help to increase the efficiency of drug development, improve cost-effectiveness, improve comparative-effectiveness analysis, and reduce duplication of effort among trial sponsors.”

Drug industry lobbyists also wrote an editorial in the NEJM, indicating that new rules and disclosures need to be handled with caution.

“A leading concern in expanding access to participant-level data is whether the privacy of research participants can be guaranteed,” wrote representatives of the Pharmaceutical Research and Manufacturers of America. “It is difficult to effectively deidentify certain data — especially data from trials concerning rare diseases or other small trials — without rendering them useless.”

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.

Last year, 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.

A growing number of Medtronic Infuse lawsuits are now being pursued in state and federal courts throughout the country by individuals who allege that the off-label use of the device resulted in excessive bone growth around the spine, causing plaintiffs to suffer nerve compression, paralysis, airway compression, retrograde ejaculations, urinary retention, cancer and other serious health problems. Plaintiffs have maintained that they suffered Infuse-related complications because Medtronic illegally promoted Infuse for uses not approved by FDA without fully informing doctors and patients of the risks.


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