Effectiveness Guidance Documents – a Method for Comparative Effectiveness Research

The primary vehicle for CMTP’s work in CER methods is the Effectiveness Guidance Document (EGD), which provides clinical researchers and product developers with guidance on how to design clinical studies that will produce the evidence needed for decision making by the healthcare community. Payers and policymakers use EGDs as evidence standards that can be used when making reimbursement and coverage decisions. In addition, EGDs provide a research framework for researchers and funding agents in the area of promising medical technologies. While these guidance documents have no legal or binding effect on any decision maker, their influence derives from the transparency, credibility, neutrality, and technical accuracy of the development process.

Product developers, payers, clinicians, patient representatives, researchers, and other relevant experts participate directly in the development of EGDs through a multi-stakeholder workgroup process. Initially, the multi-stakeholder workgroup members participate in scoping the guidance document by identifying key issues and challenges associated with the technology and the conditions being targeted by the technology. Upon completion of a draft document, workgroup members serve as a review panel, and these drafts are posted on the CMTP website for a public comment period, with active outreach to all key organizations that may have an interest in the document. After one or more iterations, CMTP then posts the completed guidance document on the website.

For more information, contact Charles Turkelson