Contrary to industry fears, we argue that access to full – though appropriately deidentified – data sets from clinical trials will benefit the research-based biopharmaceutical industry. We predict that it will help to increase the efficiency of drug development, improve cost-effectiveness, improve comparative-effectiveness analysis, and reduce duplication of effort among trial sponsors.
A managed-release environment that allows sharing of patient-level data while ensuring patient privacy would create a level playing field for all stakeholders. What is sometimes labeled as "free riding" may ultimately pay dividends for innovative companies and for public health. It is ironic that the organizations that most resist wider access to data are the ones that stand to benefit so much from greater transparency.
Dr. Hans-Georg Eichler, Frank Petavy, Dr. Francesco Pignatti, and Dr. Guido Rasi are all with the European Medicines Agency in London. Their remarks are taken from an accompanying editorial(N. Eng. J. Med. 2013 Oct. 21 [doi: 10.1056/NEJMp1310771]).
