Molecular Diagnostics used to Manage Care of Patients with Solid Tumors Effectiveness Guidance Document

While molecular diagnostics offer tremendous promise for improving health and offsetting costs in the oncology setting, there is a lack of evidence that characterizes both the benefits and harms of testing in terms that are meaningful to stakeholders. Systematic reviews have noted the lack of sufficient evidence for many of these molecular diagnostic tests, and called for more and higher quality studies to demonstrate analytic and clinical validity as well as clinical utility. However, there is considerable debate about how much evidence is needed and how it can be generated in an efficient and timely way.

CMTP has embarked on an initiative to develop an Effectiveness Guidance Document (EGD) that will provide specific recommendations on this topic. To ensure our recommendations will address areas of greatest unmet evidence needs, as well as be meaningful across a range of test platforms, this project will focus on types and levels of evidence required for sufficient demonstration of clinical validity and clinical utility of molecular diagnostics in the management of patients with solid tumors.

Analogous and complementary to the Food and Drug Administration (FDA) guidance documents, the EGD will focus on study design elements that are particularly relevant to clinical and health policy decision making. The overarching goal of an EGD is to bring together stakeholders to create a methodological blueprint which, if used, will provide these decision makers with a reasonable level of confidence that an intervention improves net health outcomes.

The EGD is funded, in part, by the Wellpoint Foundation.

Relevant Workgroups and Meetings
CMTP has convened a Technical Working Group (TWG) to provide guidance in developing EGD recommendations. The TWG is an expert, multidisciplinary team who will assist CMTP throughout the EGD development process with refining the EGD recommendations.

CMTP will also co-sponsor with the Institutes of Medicine a public workshop titled “Evidence for Clinical Utility of Molecular Diagnostics in Oncology” on May 24th, 2012 in Washington DC that will enable a larger group of stakeholders to discuss the key evidence gaps and methodological issues prior to the issuing a final version of the molecular diagnostics EGD for public comment.

Relevant Documents
The final deliverable of this project will be an Effectiveness Guidance Document (EGD).

For more information, contact Donna Messner.