A recent report by the Institute of Medicine (IOM) addresses elements that ASCO has stated are necessary for transforming the therapeutic development and clinical trial processes. In March, the IOM released the report “Evolution of Translational Omics: Lessons Learned and the Path Forward,” which includes recommendations for using test models based on “omics” technologies to predict clinical outcomes, and ways to ensure adoption and adherence to the evaluation process. The IOM uses “omics” to characterize global sets of biologic molecules such as DNA, RNA, proteins, and metabolites.
Many of the IOM report’s recommendations align with those in “Accelerating Progress Against Cancer: ASCO’s Blueprint for Transforming Clinical and Translational Research.” Released in November 2011, the Blueprint lays out ASCO’s vision and path for transforming clinical and translational research to deliver more effective and personalized cancer therapies faster.
Validated omics-based tests are a fundamental tool for cancer biology discovery and application of molecularly targeted therapies. Their creation and continued development will accelerate realization of the Blueprint.
Oversight of Diagnostic Tests
Both the Blueprint and the IOM report call for a strategy to create a clear pathway for regulatory review and oversight of diagnostic tests that relate to use of biomarkers and therapies. The IOM report further details that recommendation, stating that the FDA should “develop and finalize a risk-based guidance or a regulation on:
The Blueprint and the IOM report also include recommendations on promoting greater interdisciplinary collaboration in therapeutic development and clinical research, as well as biospecimen collection, storage, and analysis.
ASCO will be holding a session on the IOM report at its 2012 Annual Meeting, taking place June 1-5 in Chicago. The session will be held on June 1 at 1:00 PM and will be chaired by Daniel F. Hayes, MD, who also served on the committee that developed the report.
For additional information on the Blueprint, please go to www.asco.org/blueprint. ■
© 2012. American Society of Clinical Oncology. All rights reserved.