1 Boring Old Man

A Tough Push For Clinical Trial Disclosure In Europe

Pharmalot

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.

European Parliament Brokers Deal For Clinical Trial Transparency

Pharmalot

by Ed Silverman

12/20/2013

After a months-long push, a deal was reached this week at the European Parliament would require drugmakers and academic researchers to upload all results of their European clinical trials to a publicly accessible database [see this]. The move comes amid ongoing debate over the extent to which the pharmaceutical industry will agree to disclose clinical trial data in the wake of scandals that indicated safety or effectiveness information had been withheld.

“For too long, unflattering studies have gone undisclosed. Around half of all trials are never published, usually those with negative or disappointing results,” says the lead legislator for the Environment, Public Health and Food Safety Committee in the European Parliament. “It is vital that we know about negative outcomes, otherwise trials can be conducted repeatedly before it becomes public knowledge that they are ineffective, or even dangerous,” she says in a statement.

As we noted previously, transparency is not the only issue raised by Willmott. 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 [back story with a link to her report]. She also supports longer approval times required for trials, calibrating ethics committees across Europe and establishing national indemnification systems among member states. Indeed, the transparency requirement is part of broader legislation that is designed to create a more harmonized approach that will streamline clinical trial rules across Europe by allowing cross-border trials to that would enable larger studies, some of which would focus on rare diseases.

In a statement, the European Federation of Pharmaceutical Industry Associations called the overall legislation a “positive step towards restoring European competitiveness in clinical research in an increasingly competitive global market.” The trade group has repeatedly [been] criticized for shortening timelines, which can raise costs and lead to fewer clinical trials. As we have written, some drugmakers are gradually peeling back the curtain on their trial data. GlaxoSmithKline recently launched a web site and procedure for releasing data and says others are soon to join the effort. And Pfizer recently took somewhat similar steps [see here and here].

There’s a ridiculous ad on tv about the magic and ritual sports fans go through to try to bring good fortune to their favored teams. I don’t believe in that kind of silliness [unless it’s my team!]. If my team’s on the losing end, I conclude it’s because I’m watching and I go play on the computer [a lot of computer time this season in Georgia, unfortunately]. And I’m vaguely aware that I don’t say what I think about Data Transparency for fear I’ll jinx it. It’s simple to say. I think we have the winning team here. There. I’ve done it and I’m glad. Maybe this email from AllTrials contributed to my optimism: