els for data sharing can go only so far if not supported by the prevailing culture.
Many participants acknowledged the difficulty of changing well-established cultures. Educational preparation, vigorous enforcement, and consistent leadership are steps in the process of cultural change. Cultures also can be transformed by profound technological change, as is happening today with the application of Internet-based technologies and practices to health care.
Hans-Georg Eichler, senior medical officer at the European Medicines Agency (EMA), which regulates drugs and biologicals in Europe, discussed recent major policy changes at EMA regarding sharing of data from clinical trials. EMA is a public agency, said Eichler, and as a public body it is obliged to be fully transparent. The only exceptions, he said, are personal protected data and commercial confidential information. Given the overriding public health interest, EMA recently has taken the position that clinical trial data will no longer be considered commercial confidential information (Eichler et al., 2012). This has “huge implications,” according to Eichler.
Currently, EMA is providing trial reports retroactively with personal information redacted. In the future, however, it will publish trial reports proactively. The next step is making all data held by EMA publicly available, including data from prelicensing clinical trials, pharmacovigilance, and observational data. If someone asks for de-identified patient-level data, “we will make it available,” said Eichler. EMA is approaching this objective “gingerly,” he continued. The release of data puts many people, particularly from industry, outside their comfort zones. However, science is moving toward a new model of openness in which data are made available for others to reanalyze and combine with other data.
The open question is whether making clinical trials data available will be a boon or a bane for drug development and public health. One barrier to making data available is that clinical trials data include personal information that needs to be protected. However, Eichler said, “that’s probably an addressable problem.” What will likely happen is that EMA will tell industry that as of a certain date, all clinical trials data submitted to the agency will be available to anyone else, so it should not