2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
FDA Comment Number : EC22
Submitter : Mr. Glenn Siegmann Date & Time: 05/02/2005 05:05:24
Organization : Dana Farber/Partners Cancer Care
Category : Health Professional
Issue Areas/Comments
The current format and structure of IND safety reports usually do not explain enough information to allow IRB's to make any meaningful decision about these events and more importantly, incorporate that into existing consent forms, if necessary. A common numbering system for these events and standard template would allow IRBs to at least catergorize these and possibly evaluate them more efficiently as to the impact on a particular study that they oversee. When IRBs are overseeing multiple trials with these agents, as is the case with cancer centers, the same event may be reported by different Sponsors at different times. (ie. Pharmaceutical sponsors, NCI CTEP etc.) creating duplicate work. A common numbering scheme would at least allow IRBs to create a database of these events and track which ones have already been reviewed. Information on the incidence, if possible, or the number of similar events in existing pharmacovigilence databases with respect the number of patients treated with these agents, should always be provided to local IRBs. Only serious adverse events that are likely or clearly related to the agent and that may effect the subjects willingness to participate should be reviewed by the IRB. This information should be presented in a standardized, aggregated or consolidated report which has been summarized and allows for easy interpretation by local IRBs. The frequency of these reports should be based on the stage of development of the agent (ie. more frequently, perhaps quarterly, with agents in the early stage of development(Phase I or II) and less frequently, semi-annually, with late stage development (Phase III and beyond). The current system of providing IRBs with IND safety reports, from multiple sponsors, with less than adequate information does little to ensure that health care providers and patients are properly informed of new, or possibly more common, risks in any meaningful fashion.
An alternative system of having standardized, and consolidated reports reviewed by an unbiased, data safety monitoring committee that provides periodic reports to local IRBs would seem to provide better aggregate information and protection to human subjects involved in these clinical trials.