Effectiveness Guidance Documents

Effectiveness Guidance Documents – a Method for Comparative Effectiveness Research

What is an Effectiveness Guidance Document?

Effectiveness Guidance Documents (EGDs) are CMTP’s primary vehicle for work in CER methods. EDGs provide 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.

For more information on EGDs, please review our pdf EGD Overview (pdf) (590.1 kB) .

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 document.

For more information on the EGD process, please review our pdf EGD Process document (pdf) (381.59 kB) .

Why Should I Work With CMTP?

CMTP’s unique blend of expertise in stakeholder engagement and methodology provide you with a way to influencing future research by providing input on the design of clinical trials. We are committed to hearing input from all stakeholders, and to using that input that to produce an unbiased work product.

How Can I Work with CMTP on EGDs?

There are three ways you can work with CMPT on its EGDs. First, you can volunteer for one of our EGD Technical Working Group. Here is where you will join other stakeholders in their initial formulation of an EGD’s recommendations.

Second, you can nominate a topic for an EGD. CMTP is interested in receiving suggestions for EGD topics as well as other policy-related projects. We typically consider technologies that have not yet diffused widely, but are FDA-approved, and show potential to substantially improve net health outcomes

Finally, you can provide commentary on our recently developed EGDs. Click on the name of the EGD you would like to comment on. If it’s still open for comment, there will be a link at the bottom of the page that directs you to an online survey.