Evidence for Clinical Utility of Molecular Diagnostics in Oncology: A Workshop
The Center for Medical Technology Policy (CMTP) and the Institute of Medicine (IOM) Roundtable on Translating Genomic-Based Research for Health will conduct a joint workshop on May 24, 2012 to bring together a broad range of stakeholders to discuss evidence needs for informed clinical and health policy decision-making about the molecular diagnostics used to guide treatment and management of patients with solid tumors. These stakeholders will share their perspectives and discuss the major methodological issues, and corresponding evidence development strategies to advance appropriate integration of clinically useful molecular diagnostics in oncology. This event is open to the public, though space is limited .
Target Audience
- Participants attending the events will include:
- Patients and consumer advocacy groups
- Practicing medical oncologists and other clinicians
- Federal research and regulatory agencies (e.g. NIH, AHRQ, FDA)
- Public and private payers/purchasers (e.g. CMS, private health plans)
- Manufacturers and developers of molecular diagnostics
- Biopharmaceutical companies
- Clinical laboratories and experts in molecular pathology
- Clinical guideline developers and professional societies (e.g. ASCO, NCCN, AMP, CAP)
- Researchers with expertise in methods for evaluating clinical validity and utility of molecular diagnostics in cancer
Contact Information
Registration is now available for the May 24th event on the IOM’s registration website. Click “Attend this Meeting” at the top right hand of this page. For more information, contact Merianne Spencer.
Deliverables
A published Institute of Medicine report capturing the key insights for developing better evidence will be developed.
CMTP will integrate key findings from the discussions into an Effectiveness Guidance Document (EGD) that provides specific methodological recommendations for designing future clinical studies to demonstrate the clinical utility of molecular diagnostic tests used to manage patients with solid tumors.