Clinical trials information in drug development and regulation: existing systems and standards

Clinical trials provide pivotal evidence on drug efficacy and safety. The evidence, information from clinical trials, is currently used by regulatory decision makers in marketing authorization decisions, but only in an implicit manner. For clinical trials information to be used in a transparent and accountable way, it must be available in a format enabling efficient access and further processing, so that decisions can be explicitly linked to the underlying evidence. Thus, processing and management of clinical trials information plays a critical role in enabling transparent decisions. With the aim of identifying bottlenecks that prevent transparent decision making based on clinical trials evidence, we review the information systems and data standards that process clinical trials data in drug development and regulation. We find that while systems and standards for the management of single clinical trials are relatively mature, the transfer of information to the public and to decision makers is still an ad-hoc and text-based affair, and the integration of data from multiple studies remains difficult.