Evolution of Translational Omics: Lessons Learned and the Path Forward
- March 23, 2012
- Consensus Report
- Biomedical and Health Research, Health Services, Coverage, and Access
- Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials
- Board on Health Care Services
Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the National Cancer Institute requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. The IOM’s recommendations speak to the many parties responsible for discovery and development of omics-based tests, including investigators, their institutions, sponsors of research, the FDA, and journals. The report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials. The IOM’s recommendations aim to ensure that progress in omics test development is grounded in sound scientific practice and is reproducible, resulting not only in improved health care but also in continued public trust.