A new paper released this week highlights issues surrounding the discussions on clinical trial data sharing. The paper, Clinical Trials and Data Transparency: The Public Interest Case, highlights specific problems to the current draft European Medicines Agency (EMA).
Among the problems highlighted were gaps in the protection of patient privacy, further bureaucratization of an already bureaucratic system and conflicting policies on regulatory data protection. The paper concludes that the release of large amounts of detailed clinical data proposed by the EMA is not a direct,practical solution to the problems that the EMA identifies in the current clinical research environment in Europe. As a follow-up to the paper one of the authors suggested in Pharmaceutical Executive that the draft policies could have an effect of Europe being a hub for pharmaceutical innovation.
PhRMA and EFPIA issued its Principles for Responsible Clinical Trial Data Sharing in July, reflecting the biopharmaceutical sector’s strong support for responsible data sharing that recognizes the importance of protecting patient privacy, respecting the integrity of national regulatory systems, and maintaining incentives for continued investment in biopharmaceutical research. Read more