Duke scandal highlights need for genomics research criteria.

In the wake of Duke University’s decision to cancel three cancer trials that used faulty gene-array screening tests to drive therapy, federal officials are stepping up efforts to educate researchers about when to seek regulatory approval before using experimental genomic and proteomic microarray tests in clinical trials. A Duke scientist involved in the trials told an Institute of Medicine panel in late March that the university’s Institutional Review Board (IRB) thought it wasn’t necessary to seek an Investigational Device Exemption (IDE) from the Food and Drug Administration (FDA) before starting the trials, even though they used the tests to determine treatment choices and stratify patients. The National Cancer Institute will hold a two-day workshop in late June on criteria for using “‘omics-based predictors in clinical trials” where the FDA will outline the regulatory requirements for genomic and proteomic testing. The regulatory agency spelled out the requirements in a Draft Guidance on In Vitro