2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
FDA Comment Number : EC13
Submitter : Mrs. Michelle King Date & Time: 03/28/2005 03:03:01
Organization : University of Mississippi Medical Center
Category : State Government
Issue Areas/Comments
GENERAL
GENERAL
Serious Adverse events are a huge problem at our institution. We are a Southwest Oncology Group and Gynecological Oncology Group member. As a result, we have a number of drugs that are represented in both groups in many different studies. For example, we have 4 different studies with the drug cetuximab (Erbitux). Currently, there are 75 SAE's for this drug. Our IRB Director states that they have to make this data into "usable data" so they require that we submit a form that is 3 pages long requiring investigators to submit their opinion on what happened in the SAE, what they consider the attribution to be and whether or not it should be included in the informed consent document. Now, why are investigators having to submit their opinion on an SAE that did not occur at their institution? They are not the ones that are looking at all of the data, the cooperative group and the appropriate DMC's have this responsibility. If the cooperative group wants to change the ICD, let them be responsible for it, not the investigator. IRB's are putting way too much responsiblity on the investigator. And then investigators and their study coordinators have to spend their time on repeating this information several times if they have multiple studies with the same drug in it. 75 SAE's on Erbitux means over 300 SAE's submissions to the IRB with 4 different studies. It's become utterly absurd! We all want to protect human subjects and do the right thing, but investigators are spending way too much time on regulatory and not enough time on research.
My first suggestion is to take away some of this responsibility from the investigator. IRB's need to let the cooperative group/ sponsor interpret this data, not the investigator. Sure, let the investigator know about it and have him sign off on it that he is aware the SAE occurred, but don't make him interpret what it means. Let the sponsor/cooperative group do this job.

Secondly, if institutions have several studies that are open with the same drug, and with the same principal investigator overseeing these studies, let him report this only once to the IRB. Multiple reporting on the same SAE is causing a huge problem. You could report external SAE's on one form for each specific drug and this form could be filed in each appropriate study. We have made this suggestion to our IRB and they refuse to change their processes because they believe they have to put all of this data into "usable data". Well, its still usable if you do it this way, you're just not making the investigator make an opinion on external SAE's.