The Institute of Medicine is developing recommendations for the design of clinical trials involving patient genomics in an expansion of its investigation into data anomalies in Duke University research. The investigation concerns Duke's stops and restarts of cancer trials amid questions about Anil Potti's work on genomic predictors and their ability to help doctors tailor cancer treatments to individual patients.
Duke had three trials under way when critics first voiced concerns about Potti's work, according to a chronology in Nature obtained through the the U.S. Freedom of Information Act. Duke halted the trials to validate the researcher's methods. Non-Duke reviewers subsequently gave his work a thumbs-up, unaware that MD Anderson Cancer Center researchers had discovered--and reported to Duke as the review was under way--a mismatch between Potti's data and those residing in their public database source. Duke nonetheless resumed the trials. But then came allegations that Potti had lied on his CV. Duke halted the trials again.
Cancer trials increasingly involve genomics, so the time is ripe for the IoM review. For example, the institute could examine the key question of whether researchers should use genomics data to match a subject with a treatment versus random allocation of treatment with separate but simultaneous genomics study to see how they correlate, says Nature.
Duke, meanwhile, has set up a committee to determine the basic-research preconditions required for clinical trial go-aheads.
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