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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.
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Conflict of Interest Disclosure
Disclosure of Conflict of Interest: Stanley Lapidus
In accordance with Section 15 of the Federal Advisory Committee Act, the "Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable." A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.
We have concluded that for this committee to accomplish the tasks for which it was established its membership must include, among others, at least one person who has extensive current knowledge of the medical device (including omics-based diagnostic tests) industry’s involvement in omics-based research and product development.
To meet the need for this expertise and experience, Stanley Lapidus is proposed for appointment to the committee even though we have concluded that he has a conflict of interest because he is a founder, President, and CEO of a company working to develop a genomics-based test. SynapDx is a company working to develop a genomics based test to diagnose autism.
As his biographical summary makes clear, Mr. Lapidus has extensive experience in the medical device and diagnostic test industry. He possesses a great deal of experience in assessing laboratory discoveries for the purpose of commercial development, which will provide an invaluable industry perspective on product development and the regulatory process for devices. We believe that Mr. Lapidus can serve effectively as a member of the committee and that the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the work.
After an extensive search, we have been unable to find another individual with the equivalent combination of current practical experience and expertise as Mr. Lapidus who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.
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
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Major units and sub-units
Institute of Medicine
Lead
Board on Health Care Services
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