Presentation for the National Danish Ethics Council
(Den Nationale Videnskabsetiske Komité)

Abstract:

Recent US and European initiatives reflect a growing policy consensus favoring greater clinical trials and research transparency. New legislation, publishers and industry-driven projects promote independent verification of drug data, which provides a better framework for international collaboration. Greater transparency also increases public trust in research results, drugs and industry and the possibility of facilitating large cross-border clinical trials. Yet, the costs and concerns associated with opening up research and clinical trial data are also significant—for patients (protection of personal data and patient privacy), for research (misuse of clinical trial data) and for technology transfer and commercialization (obstacles to IP protection and increased exposure to litigation). This presentation will discuss these issues from an interdisciplinary perspective in order to sketch out legal mechanism that could be useful for unlocking and safe-guarding the full potential of greater transparency.




Into the great wide open: Balancing benefits and risks of greater clinical trials transparency. Recent US and European initiatives reflect a growing policy consensus favoring greater clinical trials transparency. New legislation and industry-driven projects promote independent verification of drug data, which provides a better framework for precompetitive collaboration and finding new uses for drugs. Greater transparency also increases public trust in drugs and industry and the possibility of facilitating large cross-border clinical trials. Yet, the costs and concerns associated with opening up trial data are also significant—for patients (protection of personal data and patient privacy), for research (misuse of clinical trial data) and for industry (obstacles to IP protection and increased exposure to litigation). This presentation will discuss these issues from an interdisciplinary perspective in order to sketch out legal mechanism that could be useful for unlocking and safe-guarding the full potential of greater transparency