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An IOM committee will review the published literature to identify appropriate evaluation criteria for tests based on "omics" technologies (e.g. genomics, epigenomics, proteomics, metabolomics) that are used as predictors of clinical outcomes. The committee will recommend an evaluation process for determining when predictive tests based on omics technologies are fit for use as a basis for clinical trial design, including stratification of patients and response to therapy in clinical trials.
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Consensus
·2012
Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detec...
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Description
An ad hoc committee will review the published literature to identify appropriate evaluation criteria for tests based on “omics” technologies (e.g. genomics, epigenomics, proteomics, metabolomics) that are used as predictors of clinical outcomes. The committee will recommend an evaluation process for determining when predictive tests based on omics technologies are fit for use as a basis for clinical trial design, including stratification of patients and response to therapy in clinical trials. The committee will identify criteria important for the analytical validation, qualification, and utilization components of test evaluation.
The committee will apply these evaluation criteria to predictive tests used in three cancer clinical trials conducted by Duke University investigators (NCT00509366, NCT00545948, NCT00636441). For example, the committee may assess the analytical methods used to generate and validate the predictive models, examine how the source data that were used to develop and test the predictive models were generated or acquired, assess the quality of the source data, and evaluate the appropriateness of the use of the predictive models in clinical trials.
The committee will issue a report with recommendations regarding criteria for using models that predict clinical outcomes from genomic expression profiles and other omics profiles in future clinical trials, as well as recommendations on appropriate actions to ensure adoption and adherence to the recommended evaluation process. The report will also include the committee’s findings regarding the three trials in question.
Contributors
Committee
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Committee Membership Roster Comments
Joe Gray and Elda Railey were added to the committee.
Stanley Lapidus was added to the committee.
Sponsors
Department of Health and Human Services
Staff
Sharyl Nass
Lead
Major units and sub-units
Institute of Medicine
Lead
Board on Health Care Services
Lead
