Duke cancer trials allegedly lacked proper clearances

January 28, 2011

After starting a misconduct investigation, suspending three clinical trials, and triggering an expensive Institute of Medicine (IOM) probe into the use of genomics technology in clinical trials, Duke University does not yet seem to be anyways near to moving on from the legal and ethical quagmire surrounding the work of cancer geneticist Anil Potti.

Today’s issue of The Cancer Letter reports that Duke has had auditors from the Food and Drug Administration (FDA) on its campus, potentially because the university failed to obtain its approval for the trials, which were based on Potti’s research. The trials did not involve testing new drugs on patients. However, Potti’s genomics technology – now known to be flawed -- was used to determine what drug patients would receive and The Cancer Letter reports that officials at the FDA – which regulates medical devices – regard themselves as having jurisdiction. Specifically, a clearance called an "Investigational Device Exemption"(IDE) was needed to cover use of the genomic chips used to test patients for biomarkers believed to indicate the drug sensitivity of their cancers.

Around 110 patients were enrolled in the trials. Duke administrators have been under fire over their response to concerns brought to their attention by external biostatisticans, specifically their decision to withhold a critical report uncovering data flaws from a review panel they had charged with reviewing Potti’s research.

The FDA is co-sponsoring the IOM probe with the National Cancer Institute, where officials had also raised concerns about Potti’s work while the trials were ongoing.
Sensitively for Duke, documents show how Potti’s co-author, Joe Nevins, tried to get an IDE for use of a closely related technology, apparently believing one was needed. Yet in other documents, Duke’s Institutional Review Board put N/A for non-applicable next to checkboxes intended to indicate whether this form of FDA clearance had been obtained.
The Cancer Letter also reports that a Duke center directed by Nevins has been shut down to allow him to concentrate on the investigations surrounding his work with Potti.
Image: West Campus/ Duke Photography

http://blogs.nature.com/news/thegreatbeyond/2011/01/duke_cancer_trials_allegedly_l_1.html