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Providing Methodological Guidance

When evidence is lacking, we develop standards and recommendations

Intensifying cost pressures and new models of shared risk (e.g., Accountable Care Organizations) continue to drive interest in evidence on the comparative effectiveness and value of new or existing drugs, treatments, and medical devices. Payers need this evidence to determine coverage, while patients, consumers, clinicians, and others need it to make better care decisions.

However, life sciences companies and clinical researchers have limited information about what specific additional evidence payers and others need. Product developers also worry that generating additional evidence may increase the cost of clinical development and impede the pace of innovation. The result: broad uncertainty about how best to develop and test new and needed interventions.

To generate better evidence of real world benefits and harms while sustaining innovation, CMTP provides guidance on research methods that can reduce this ambiguity and fill important knowledge gaps. In particular, we:

  • Develop and publish research standards and methodological recommendations specific to particular conditions or clinical questions for which CER evidence is lacking.
  • Disseminate methodological recommendations to achieve broad uptake in the medical community. 
  • Advise public and private sector researchers, product developers, and policy makers on clinical and real-world study designs based on CMTP-developed CER standards and recommendations.  

As part of this work, CMTP serves as the host of the Green Park Collaborative, a multi-stakeholder forum which seeks to develop condition-specific study design recommendations and standards.  In this unique partnership, public and private sector experts work together to develop the evidence needed to inform coverage and payment decisions in the United States. In disease-specific consortia, working groups develop effectiveness guidance documents, which provide direction on the clinical study designs needed to fill systematic evidence gaps more efficiently and, through the creation of that evidence, improve clinical and policy decision-making.