Strong Push for Clinical Trial Disclosure in Europe

Strong Push for Clinical Trial Disclosure in Europe

February 4th, 2013 // 6:43 pm @ jmpickett

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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 of 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 adament 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 is not the only issue raised by Willmott in response to the proposed legislation. She endorses the idea of overarching regulation for running trials that would, in particular, better serve the needs of small populations of patients with rare diseases. She also supports longer approval times required for trials, harmonizing ethics committees across Europe and establishing national indemnification systems among member states.

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).

Such calls are a response to scandals and dust-ups in which important data about various drugs was not known yet safety and efficacy issues swirled around the medications. These included the Avandia diabetes pill sold by GlaxoSmithKline (GSK) and the Tamiflu treatment from Roche (RHHBY). Last fall, Glaxo responded by agreeing to make available patient-level data to independent researchers, a step that came after the drugmaker paid a $3 billion settlement to settle civil and criminal charges that included a failure to release trial data (see this). Roche, meanwhile, is still haggling over Tamiflu data requested by the Cochrane Collaboration (look here).

Meanwhile, the British Medical Journal will no longer publish studies unless “the relevant anonymised patient level data available (is made available) on reasonable request,” according to a new policy that was adopted last month. BMJ is also one of several organizations sponsoring an online petition calling for drugmakers to make public all trial data (see this).

The effort finally prompted the Pharmaceutcal Research and Manufacturers of America to respond. In a harsh statement today, the US industry trade group takes both BMJ and physician Ben Goldacre, who recently wrote a book called ‘Bad Pharma,’ to task for not only insisting on the disclosure patient-level trial data, but also accuses Goldacre of relying on faulty examples to bolster his contentions.

“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.