Print“Transparency and open communication remain important principles of the conduct of science, whether reporting data and code, disclosing conflicts of interest, or reporting potential breaches in scientific procedures.”
The Institute of Medicine has outlined best practices for developing and assessing molecular diagnostic tests in a new report requested by the National Cancer Institute at a time when skepticism over the validity of some tests overshadowed excitement about their potential.
The report reviews what has been learned since the first sequencing of the human genome in 2001 and how the evolution of genomic, proteomic, and metabolomic sciences can help scientists and ultimately doctors gain a new understanding of the molecular and genetic basis of disease.
The institute recommends a detailed process to evaluate whether the data and computational steps underlying such tests are sound and the tests are ready to be used in clinical trials. The process defines responsibilities and best practices for the investigators, research institutions, funders, regulators, and journals involved in the development and dissemination of clinical “omics-based” technologies.
Need for the guidelines became clear in 2011 when scientists raised serious concerns about several genomic tests developed to predict patients’ sensitivity to chemotherapeutic agents developed by investigators at Duke University. Payers are also putting increasing pressure on companies to demonstrate that their products are not only safe and effective, but also deliver value, and proof that their tests are valid and useful in the clinic.
By identifying best practices for the development, evaluation, and translation of omics-based tests, the institute says it hopes to strengthen steps taken to ensure that such tests are appropriately assessed for scientific validity before they’re used to guide patient treatment in clinical trials.
In addition to its recommendations, the report, “Evolution of Translational Omics: Lessons Learned and the Path Forward,” also details six case studies of currently available tests that informed its recommendations, including Genomic Health’s Oncotype DX test, Vermillion’s OVA1, and XDx’s AlloMap.
“The committee identified several overarching themes in design, conduct, and oversight of omics research from the Duke case study,” the authors write. “Among these themes, transparency and open communication remain important principles of the conduct of science, whether reporting data and code, disclosing conflicts of interest, or reporting potential breaches in scientific procedures.”
March 30, 2012
http://www.burrillreport.com/article-new_guidelines_on_taking_life%e2%80%99s_measure.html
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