Bringing trial data out of the shadows

All sectors have their own mood music, unobtrusive much of the time, but occasionally brought to startling effect into the foreground, dominating all else. The pharmaceutical industry is no different, and at present there is one insistent theme: transparency.And if there is one area of this debate behind which chords are starting to swell loudly it is the availability of clinical trial data. Unflattering or disappointing trial outcomes have been routinely unpublished, pharma's critics claim, which means patients taking part in trials can be exposed to ineffective or even dangerous products because previous negative research is unavailable.Clash of opinionsFor its part, pharma denies there is a problem. At present, companies operating in the UK, for example, are expected – though not obliged - to register current and future trials within 21 days of enrolling the first patient, with results published within one year of marketing authorisation.This does not go far enough, according to some. The European Commission, for instance, is in the process of revising the Clinical Trials Directive (2001/20/EC), and putative changes would require a results summary to be put on to the EU's clinical trial database within a year of the end of the relevant trial. The lead legislator on the revision process is Labour MEP Glenis Willmott, who wants a pan-European database, with full publication of trials - and financial penalties for firms which delay. “Too many results f...
Source: PharmaGossip - Category: Pharma Commentators Authors: Source Type: blogs