2005N-0038 - Adverse Event Reporting to Investigational Review Boards Public Hearing
FDA Comment Number : EC4
Submitter : Dr. Arvid Zuber Date & Time: 02/23/2005 01:02:59
Organization : Saint Luke's Hospital of Kansas City IRB
Individual Consumer
Category :
Issue Areas/Comments
I am in my 20th year as a member of an IRB. We, routinely, review the reports of adverse events at our bimonthly meetings. For some time I have been concerned about the reporting because the reports are of Adverse Events. As such they include everything out of the ordinary that occurs during a clinical study. It would be very helpful if what we see was limited to Adverse Reactions, that is, events that are at least possibly related to the study drug or procedure. It is confusing and a waste of time to go through a list of say twenty AE's and find that perhaps two are possibly related to the study drug. Also, we may find as many as four or more reports are all of the same event at different stages of the reaction or follow- up.
I also have had occasion to download reports of reactions from the FDA data base and found much confusion there, particularly when the patient was on multiple drugs and it was virtually impossible to separate related from unrelated reactions and in some cases the natural course of the disease.
I recognize the desirability of getting all possible information. However, when everything related and unrelated is reported there is a lack of focus and, though I am not an M.D. and am not involved in the reporting requirements, the broad reporting requirement must result in diminishing the importance of the data in the eyes of the responsible investigator with, I think, predictable results.