Access to data in industry-sponsored trials : The Lancet
Connotea Imports 2012-07-31
"The importance of transparency and data sharing in clinical research is increasingly emphasised, and public funders increasingly require that all data from publicly sponsored research are made available.1 The same cannot be said for industry-sponsored trials, for which the sponsors often own the data and the academic authors have limited publication rights....11 of 18 editors replied to our survey (61% response rate). Nine editors considered that full access to any CRF on request and access to raw data were mandatory when corresponding authors declared “full access to all the data”. Our most important finding was the huge discrepancy between the protocols and the papers on access to data....[A] survey of US academic institutions found that trial agreements rarely ensured that authors had independent access to all trial data. Furthermore, the Pharmaceutical Research and Manufacturers of America have stated that academic authors should be provided with summary data only....[W]e should work towards a situation in which anonymised raw data are made freely available to the public. Our patients deserve nothing less than this, which would be highly beneficial for health care."