Big Pharma’s data sharing principles “weak and filled with loopholes”

Campaigners for greater transparency of clinical trial data for medicines have criticised a set of principles published by the pharma industry aimed at improving access to study information.Led by pressure group AllTrials, numerous critics have said that the commitments, published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the US' Pharmaceutical Research and Manufacturers of America (PhRMA), go nowhere near far enough in allowing independent researchers to determine if a drug is as effective as its manufacturer claims.Among the most damning comments were those from AllTrials co-founder Dr Ben Goldacre, who remarked that the principles were “weak and filled with loopholes”, especially with regard to the limited timeframe suggested by the trade bodies."EFPIA and PhRMA seem to be suggesting that transparency should only happen for new trials, and reports submitted to regulators after 2014,” said Dr Goldacre.“This will do nothing to remedy the incomplete evidence that doctors and patients are being forced to use right now, on the medicines we use every day and came to market over the past few decades. Sharing trial information going back for at least two decades is vital.”Dr Goldacre also criticised the review process proposed by EFPIA and PhRMA, which would require any researcher wanting access to data to submit a research proposal to document the legitimacy of the research question and their own qualifications, and for th...
Source: PharmaGossip - Category: Pharma Commentators Authors: Source Type: blogs