By Jonathan Larsen, MPP, Program Coordinator
On Thursday, May 24, 2012, the Institute of Medicine (IOM) Roundtable on Translating Genomic-Based Research for Health and the Center for Medical Technology Policy (CMTP) cohosted a full-day public meeting in Washington, DC, entitled, "Evidence for Clinical Utility of Molecular Diagnostics in Oncology: A Workshop." The main goals of this workshop were to discuss what evidence is needed to establish clinical validity and utility for molecular diagnostics used in treatment decision-making and to explore innovative models for establishing evidence of clinical utility in oncology. This workshop convened a wide array of stakeholders, including representation from patients and consumer advocacy groups, oncology and other professional groups, federal research and regulatory agencies, public and private payors, molecular diagnostics developers, pharmaceutical companies, clinical laboratories, researchers, and organizations that develop clinical practice guidelines.
The meeting featured three moderated sessions, introduced by stakeholder presentations and concluded with interactive roundtable discussions. The first session, "Evidence Utilization," explored the clinical guideline development process in oncology, payor perspectives on evidence evaluation, and patient and provider decision-making regarding molecular diagnostics in oncology. The afternoon sessions, "Study Design and Analysis" and "Advancing Molecular Diagnostics for Oncology," covered a number of topics, including but not limited to, statistical, methodological, and cost-effectiveness issues related to the evaluation of molecular diagnostics and next steps for collaboration to develop evidence, respectively. A major point of interest for all stakeholders was determining when more intensive clinical trials are necessary for the development of molecular diagnostics.
Al B. Benson III, MD, FACP, Professor of Medicine and Associate Director for Clinical Investigations at Robert H. Lurie Comprehensive Cancer Center of Northwestern University, presented the development process for the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). He noted that there are more than 800 biomarker recommendations in current guidelines and described the NCCN Biomarkers Compendium™ currently under development to ensure access to appropriate testing as recommended by the NCCN Guidelines.
The workshop will be followed by the publication of an IOM report addressing the meeting's significant findings for developing better evidence of clinical utility and integration of this information into a CMTP Effectiveness Guidance Document that will cover specific methodological recommendations for demonstrating clinical utility of molecular diagnostics in new clinical studies.