Look,It's Someone Doing Their Job!

The New York Times today reported a story about Dr. Suzanne Stratton, a Ph.D. molecular biologist and researcher in clinical oncology, who was brought in to oversee the quality of clinical trials at Carle Cancer Center in Urbana, IL. Upon taking up her position, Dr. Stratton finds, among other issues, failures to properly consent patients in cancer trials. In the world of clinical studies, this is a major "No No." In addition to opening up the institution to considerable liability if, let's say, the patient died due to an experimental treatment that was not properly explained, that patient should also properly be taken out of the enrollment pool for the study because of the failure to properly document informed consent.

It sounds like Dr. Stratton had done her job and found this fundamental violation of good clinical practice, and had pointed it out to her superiors, along with other issues. For this, she was discharged and led out of the office the same day. In the mean time, it turns out that one Principal Investigator at Carle, Dr. Ken Rowland, "has simultaneously overseen more than 130 clinical trials in more than 20 cancer types, ..., and he personally enrolled about one-quarter of the 500 patients Carle signed up for experimental treatment in a typical year." This is analogous to a lawyer billing 5,000 hours a year--implausible to say the least.

This kind of high volume throughput does lead, just like in the financial world, to moral hazard and perverse incentives. In fact, the NYT article suggests that "doctors too often promoted trial treatments as superior to standard approaches, even when there was no supporting evidence."
Get 'em in and get 'em enrolled, and let's bill the Government based on enrollment. The primary body for regulatory oversight in this setting is the Institutional Review Board (IRB), and Dr. Stratton had the temerity to suggest that it was too deferential to researchers and did not maintain its own, independent documentation.

Kudos to Dr. Stratton for doing what she was supposed to do and for following the chain of command and for calling it like she saw it.