Handling of safety information during clinical trials with reference to ICH guidance and CIOMS recommendations

摘要

The CIOMS VI and VII reports contain significant recommendations which could dramatically change the way safety information is communicated by sponsors of clinical trials. The reports make specific recommendations regarding the determination of "expectedness" using the DCSI which conflict with current practices in Japan and recommend that only unexpected reports be subject to expedited reporting to regulators. The recommendations on reporting to investigators would represent an even more substantial change in that the reports advocate a shift from the current system of relying on reporting of individual case reports to periodic reporting of aggregate safety information. Finally, the reports make some recommendations on the management of causality determinations for individual adverse event reports which seek to simplify and unify current practices. It is unclear how many of these recommendations can be adopted in the current environment of heightened safety concerns during clinical development but the CIOMS reports challenge us to reconsider our current practices to improve the communication and management of safety information during clinical development.