A Tough Push For Clinical Trial Disclosure In Europe
By Ed Silverman
February 4th, 2013
As the debate over clinical trial transparency heats up, the lead legislator for the Environment, Public Health and Food Safety Committee in the European Parliament wants to toughen proposed legislation that is designed to bolster clinical trial practices and activities on the continent. And one of her suggestions is already meeting with some resistance from the pharmaceutical industry. Specifically, lead legislator Glenis Willmott wants full clinical studies – not summaries – to be submitted and, therefore, available for disclosure. “Your rappoteur is the opinion that a sample summary of the results from the sponsor does not go far enough, as it could be biased or misleading,” she writes in a statement released late last week. Rappoteur is the lead legislator on a bill; Willmott is from the UK, by the way.
In her view, company data can be protected in line with existing measures, although drugmakers continue to raise concerns that trade secrets could be compromised. In fact, the Association of British Pharmaceutical Industry issued a statement saying that, “if the entire file with all studies is released other companies can get approvals around the world. Anyone can get an approval as long as they submit the necessary data.” Nonetheless, Willmott is adamant and proposes to fine drugmakers that do not submit all pertinent clinical trial information to a database within one year. And she also believes that all data should be archived indefinitely, instead of the five-year period proposed by the European Commission. “Should a sponsor come under investigation for misconduct, the clinical trial master file would be vital,” she writes [here is her report]…
Transparency, though, has arguably been the most contentious of the various issues addressed in the legislation. Last month, the Health Committee at the UK’s National Institute for Health and Clinical Excellence has issued a report calling for drugmakers to place all information in “the public domain” and create a voluntary code for publicly releasing trial data for drugs once they have been reviewed and made available for clinical use [back story]…“The demands by Dr. Goldacre and the British Medical Journal to release patient-level clinical trial data are irresponsible with potentially harmful consequences for future medicine development. The recommendations would jeopardize patient privacy and could serve as a deterrent to individuals considering participation in trials. It would also encourage second-guessing of the regulatory approval process, which would be disastrous for patients. The FDA has the most advanced and rigorous review process for potential new medicines and it is continuously improving its regulatory and scientific capabilities,” PhRMA says in its statement.
Your Rapporteur is therefore recommending requiring sponsors to publish a full clinical study report on the EU database. The clinical study report is already a generally accepted international guideline and a comprehensive account of how the trial was carried out, and what the findings were. Many sponsors already prepare these reports, which are submitted to the regulatory bodies when applying for marketing authorisation. It includes a simplified summary, but also the much fuller results which can be analysed and checked by independent researchers. Clearly patients decide to take part in a trial to help advance medicine for themselves and other patients in their situation, not to help a particular company. Sharing more knowledge about trial results will not only increase trust in medicines, but accelerate the development of live-saving treatments. It will not compromise data protection, as all personal patient data will be anonymised.