2005N-0038 - Adverse Event Reporting to Investigational Review Boards Public Hearing
FDA Comment Number : EC7
Submitter : Dr. George Schnetzer Date & Time: 03/14/2005 09:03:28
Organization : St. Francis Healthcare Adult Oncology IREB
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
As an IREB chair for a healthcare system holding a CCOP grant, I'm faced each week with many Adverse Event reports from all over the world (over 900 in the last 12 months) related to drugs currently and previously used in our CCOP protocols. In an effort to expedite these matters, which, if considered by the convened IREB, would constitute our entire agenda, I attempt to sort out those which may have some meaningful impact on the health and safety of our research subjects from those which are irrelevant (over 95% in my experience).
The causes of these reports' irrelevance are several: incompletely documented medical records, sometimes omitting such fundamental considerations as principal diagnoses, complicating medical conditions and other medications taken concurrently, inability to separate symptoms and signs due to disease from those due to the underlying medical condition and failure to document the presence or absence of a cluster of such new symptoms or signs in a cohort of patients taking the drug in question. If there ever existed a sitution where some type of central review board could make a valuable contribution, this is it. Why not convene a group under the auspices of the FDA or the OHRP which would screen these reports, filtering out those which had essential gaps in documentation, are clearly unrelated to the drug in question or are obviously only tenuously related to a single subject and passing through those which raise significant questions which should provoke an IREB's scrutiny? In so doing you'd facilitate the work of many dedicated IREB volunteers, reduce staff burdens on participating institutions and free chairmen, like myself, to devote more time to the serious business of promoting the safe and effective conduct of clinical research in the community setting.