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White Papers resources

coreHEM: Developing Comparative Effectiveness Outcomes for Gene Therapy in Hemophilia
coreHEM has produced the first set of guidelines recommending a specific, minimum set of outcomes to include in hemophilia gene therapy clinical trials. This core set will ensure that patient perspectives on critical outcomes are included in pivotal trials, allow fair comparisons between alternative treatments, and allow more accurate assessments of the value of these therapies. The coreHEM project was jointly led by the Green Park Collaborative (GPC), the National Hemophilia Foundation (NHF), and McMaster University.
A Multi-Pronged Strategy to Improve the Relevance, Usefulness, and Comparability of Outcomes in Clinical Research
Developed through multi-stakeholder discussions, this white paper outlines major challenges and considerations for development and utilization of core outcome sets (COS) in clinical research, and identifies potential solutions to these challenges.
RWE Decoder: A Practical Tool for Assessing Relevance and Rigor of Real World Evidence
GPC developed a tool to help healthcare decision makers confidently and consistently use Real World Evidence (RWE) when making tough coverage and care choices.
A Multi-stakeholder Agenda to Advance Enhanced Recovery for U.S. Surgical Patients
This white paper builds upon earlier work, including a multi-stakeholder forum in which participants discussed potential challenges and opportunities to accelerate the adoption of Enhanced Recovery Protocols (ERPs) in the U.S. The white paper shares key insights from the forum regarding potential steps to overcome barriers, and proposes a roadmap to accelerate the adoption of ERPs in the U.S.
The Current Drug Development Paradigm: Responding to US and European Demands for Evidence of Comparative Effectiveness and Relative Effectiveness
Pharmaceutical companies face rapidly evolving regulatory and reimbursement evidentiary expectations linked to the clinical and economic realities confronting the healthcare system. Health care spending pressures, a lack of information to guide the efficient use of new technologies, and consequent political momentum are promoting the need for an enhanced generation of evidence to inform post-regulatory clinical and coverage decision-making. This white paper serves to ascertain how the current drug development paradigm at five global pharmaceutical companies is evolving in response to perceived demands for evidence of comparative effectiveness and relative effectiveness, in particular, from payers and HTA bodies, but also from clinicians and patients.
Payer Perspectives on Improving Usability of Effective Health Care Products (February 2014)
Bridging the Gap Between Information Needs and Evidence Translation. This report, produced for AHRQ's Effective Health Care (EHC) Program, provides payer perspectives on how to improve the usability of reports produced by the EHC program.
Early Pharmaceutical Pragmatic Clinical Trials (December 2013)
A white paper on the historical context for a discussion about pragmatic clinical trials and their place in drug approval.
Evaluation of Clinical Validity and Utility of Actionable Molecular Diagnostic Tests in Adult Oncology (May 2013)
While molecular diagnostics offer tremendous promise for improving health and offsetting costs in the oncology setting, the benefits and harms of testing are often not well known in terms that are meaningful to stakeholders. This EGD serves to close the gap between the presumed benefits of tests undergoing technology assessments and the information needs of payers, clinicians and patients. We provide specific recommendations for designing studies to evaluate the clinical validity and utility of 'actionable ' MDx tests, meaning those tests intended to guide clinical decision-making for patients with a known diagnosis of cancer.
Improving the Quality and Efficiency of the Medicare Program Through Coverage Policy (August 2011)
This issue brief focuses on the role of payers in achieving Medicare's "triple aim" of improving the care experience, improving health, and reducing costs. It is a collaborative effort from CMTP and the Urban Institute.
Medicare Data United with Simple Clinical Trials Expanded (May 2011)
This collaborative 'network of networks ' was formed to provide the research infrastructure for trials to study comparative effectiveness of therapeutics in the treatment and management of chronic diseases. CMTP led a workshop on CER in Osteoporosis in May 2011.
CED in the Private Sector (July 2010)
A briefing document exploring how CED could be implemented in private health plans.
MEDPAC Report (May 2010)
A review of the comparative effectiveness research (CER) landscape in the United States and its relevance to the Medicare program. CMTP was commissioned to complete this project by the Medicare Payment Advisory Commission (MEDPAC) as part of its continuing effort to explore ways to give Medicare flexibility to be a more innovative, value-based purchaser.
Coverage with Evidence Development Issue Brief (January 2009)
This issue brief summarizes a recommended framework for CED that would allow private and public health plans to collaborate on a single CED initiative.