2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
FDA Comment Number : EC24
Submitter : Dr. Robert Herndon Date & Time: 05/02/2005 05:05:51
Organization : Univ. of Mississippi Medical Center
Category : Health Professional
Issue Areas/Comments
The process of sending all adverse events to every site which must send it to their IRB on their forms, must receive and file a reply and keep track of every item is wasteful and extraordinarily inefficient for no significan gain in safety, in fact it is likely detrimental to safety. When several AEs per week cross your desk including unrelated SAEs (such as being hospitalized for unrelated elective surgery or being injured by a tornado requiring hospitalization). A central IRB with physicians and pharmacists expert in the appropriate areas as well as having lay representation to thoroughly screen events and decide on necessary changes would do a much better job than the current arrangement with improved safety. That central IRB could then send periodic summaries of relevant events to the investigators and local IRBs. Serious adverse events that are treatment related would continue to be sent to investigators and local IRBs. The central IRB could also initiate changes to the consent documents and protocols. The paper work currently involved in a trial in which I have only one patient who developed an allergic reaction two years ago and has been off study drug since continues to come in. The amount of paper that crosses my desk is more than in a similar trial 13 years ago in which I had 79 patients.

Another problem is the consent document. A 20 to 30 page consent, even if kept to an 8th grade level is ineffective in informing the patient of risks. Some way needs to be found to shorten the documents and minimize the multiple minor changes that occur during a trial. These items may seem unimportant but they contribute enormously to the cost of new drugs. They also seriously discourage investigators such as myself, who do not have a large clinical trials staff, from participating in clinical trials