European Parliament Brokers Deal For Clinical Trial Transparency

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 cre...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs