CHICAGO—Serious and fatal drug reactions tripled between 1998 and 2005, according to a 2007 FDA analysis. In that time period, the total number of serious adverse drug events multiplied 4 times faster than the number of prescriptions written. Th e number of serious drug reactions for biotechnology agents rose nearly 18-fold (T Moore et al: Analysis of FDA reported post marketing ADR database, Arch Intern Med 167:1752-1759, 2007).
At the 2008 Oncobiotechnology Research, Clinical and Business Summit at Northwestern University, a panel of experts from the biotechnology industry, FDA, and the clinical research setting discussed how all segments of the research community must work together to provide better oversight of drug safety. Addressing the topic of drug safety monitoring, Janet Lee Nichol, an independent biotechnology consultant based in Oxnard, Calif., said the onus was on clinical trial sponsors to review outcomes on an ongoing basis.
“Sponsors of clinical trials need to identify a product-independent, internal group that will review outcomes in an ongoing way so they can look for signals of adverse events before the next safety monitoring period comes up,” she said.
“You don’t want to wait a long period of time and have adverse reactions developing. You want to look for problems with or without the safety monitoring board, and you want the review to be independent both in terms of the product being tested and the company that is testing it.” “You also need to proactively identify the types of outcomes that would be ‘deal breakers,’” Ms. Nichol added. “These are the types of adverse reactions that would cause termination of the drug administration.
It’s much easier to do that before you see events than during a clinical trial program when you actually find them.” Charles L. Bennett, MD, PhD, professor in the division of hematology and oncology at the Feinberg School of Medicine at Northwestern University in Chicago, discussed the university’s Research on Adverse Drug events And Reports (RADAR) project that aims for an independent, systematic review of adverse reactions.
“RADAR investigates reports of serious adverse reactions made by hematologists and oncologists throughout the world, analyzes the data from those investigations, and publishes the results in peer-reviewed journals,” Dr. Bennett said, citing examples of how RADAR tracks serious drug reactions.
“In one case, RADAR investigators found 13 cases of thrombotic thrombocytopenic purpura (TTP) in patients who took clopidogrel (Plavix),” he said. “In that work, we set up a consortium of blood banks that would call us as soon as someone showed up with TTP so we could see if the patient took clopidogrel. Within three months of having all these blood banks on alert, we got 11 calls and found that all 11 people had taken clopidogrel. Within six months, we had a signal that the drug was related to TTP.”
RADAR is also enlisting other specialists to contribute to the database.