Lapses in oversight compromise omics results

Apr 17, 2012 by Journal of Proteomics and Bioinformatics

Lapses in oversight that prevented a US university from identifying the flawed research behind a series of clinical trials are symptomatic of a larger problem says a report by the US Institute of Medicine (IOM), released today. The case in question, which revolves around papers relating to cancer treatment published by researcher Anil Potti, indicates a need for higher standards in the development of tests based on genomics, proteomics and similar large-scale studies, the report says.

Loosely dubbed ‘omics’, such large-scale studies of genes, proteins and other molecular characteristics of whole organisms have been lauded as a way potentially to detect disease and evaluate how people respond to drugs. In theory, the approach could pave the way to personalized treatments. But the development of reliable clinical tests based on omics findings has taken longer than expected.

In a bid to improve how omics-based clinical tests are developed and evaluated, the US National Cancer Institute (NCI) in Bethesda, Maryland, asked the IOM to investigate after an analysis by an NCI biostatistician, Lisa McShane, led to the discovery that data used in Potti’s studies had been altered. That discovery led to the closing of clinical trials, retractions of over two dozen published papers, a misconduct investigation into Potti’s behaviour and lawsuits against Potti and his former institution, Duke University in Durham, North Carolina. His studies had linked changes in the expression of patients’ genes with how they responded to cancer treatments, and independent statisticians had raised concerns about published papers linked to the work before clinical trials were initiated based on them (see ‘Cancer trial errors revealed‘).

The IOM report issued today details how multiple failures of the systems that Duke relied on to protect research oversight and integrity enabled the clinical trials based on Potti’s data to proceed. And, the report warns, “Many of these failures stemmed from problems that may exist at other institutions,” including problems with trial design in omics studies, and with research oversight, data management and systems for managing conflicts of interest more broadly.