EMA pressured on gateways

While industry would like to restrict access to patient-level clinical trial data in Europe through a gatekeeping mechanism, opponents are telling EMA that anything less than open access will simply perpetuate the existing disclosure system and prevent third-party analyses from being reproduced.

Industry wants the agency to adopt a gatekeeping model following some - but not necessarily all - of the system used by GlaxoSmithKline plc, which requires third-party researchers to submit their analysis plans for review by an independent panel of experts...