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Comparative Effectiveness Research resources

Evaluating the comparative effectiveness of treatment sequences in oncology: a new approach
Messner DA, Towse A, Mohr PE, Garau M. The future of comparative effectiveness and relative efficacy of drugs: an international perspective. J Comp Eff Res. 2015;4(4):419-27. doi:10.2217/CER.15.6. PMID: 25730094. ISSN: 2042-6305.
Demonstrating the Clinical Utility of Next Generation Sequencing in Clinical Oncology
The Green Park Collaborative convened a multi-stakeholder meeting July 7, 2014 to discuss the methods and standards for evaluation of the clinical utility of next generation sequencing (NGS)-based testing in oncology. This meeting kicked off a series of discussions that will take place through the spring of 2015 and will culminate in the creation of an Effectiveness Guidance Document.
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.
Stakeholder Defined Research: Designing Studies that reflect the perspectives of patients, clinicians and payers (February 2014)
This is a presentation given by Pat Deverka as part of EPG Grand Rounds, at the University of Maryland
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.
Endocrine Metabolic Consortium Overview (Nov 2013)
As part of GPC-USA, the Endocrine-Metabolic Consortium will develop methodological standards for patient-centered outcomes research and comparative effectiveness research in endocrine and metabolic diseases.
COMET Initiative: Core outcome measures in effectiveness trials (Nov 2013)
This presentation was part of the Green Park Collaborative-USA 2013 Annual Meeting
Oncology Overview (2013)
Part of GPC-USA, the Oncology Consortium will develop methodological standards for research research in oncology.
EGD Overview (2014)
This document provides background on the purpose of EGDs, a framework for creating them, insights on scope and topic selection, and the development process.
Development of an EGD for Patient Reported Outcomes in Oncology (May 2013)
Ethan Basch, MD, and Amy Abernethy, MD gave this presentation at the Inaugural Green Park Collaborative meeting.
Methodological Recommendations for Comparative Effectiveness Research on the Treatment of Chronic Wounds (October 2012)
This EGD provides specific recommendations to product developers and clinical researchers on the design of comparative effectiveness studies for the treatment of chronic wounds, specifically those pertaining to arterial and venous disease-related ulcers, diabetic foot ulcers, pressure ulcers, and burn wounds
Stakeholder Engagement in Comparative Effectiveness Research: How Will We Measure Success? (Sept 2012)
Lavallee DC, Williams CJ, Deverka PD, Tambor ES. Stakeholder engagement in comparative effectiveness research: how will we measure success? J Comp Eff Res. 2012;1(5):397-407. doi: 10.2217/CER.12.44
2011 CER Summit Report
A summary of the 2011 CER Summit which explored the challenges and opportunities for improving evidence generation and care for cardiovascular disease.
Bending the Cost Curve Through Comparative Effectiveness Research (June 2012)
During a presentation at ASCO 2012, Sean Tunis summarized how CER can help provide better information about the costs and benefits of different treatment options, which when combined with the right incentives, can reduce the cost of healthcare.
Recommendations for Incorporating Patient-Reported Outcomes into Clinical Comparative Effectiveness Research in Adult Oncology (May 2012)
This EGD provides recommendations to set a minimum standard that will ensure that data collection allows for examination of patients ' directly reported experiences in diverse studies of treatment effectiveness and outcomes in oncology.
Incorporating Stakeholder Perspectives In Developing a Translation Table Framework for Comparative Effectiveness Research (May 2012)
Gliklich RE, Tunis SR, Mohr PE, Messner DA, Moloney RM, Karkare SU, et al. . J Comp Eff Res. 2012; 1(3), 281-292. doi: 10.2217/cer.12.25.
Methodological Guidance for Molecular Diagnostics Research in Oncology Workshop Slides May 2012
A presentation by Sean Tunis on evidentiary standards for determining the clinical utility of genomics-based diagnostic tests.
Comparative Effectiveness Research: What is it? Why do it? What 's Happening Now?
Donna Messner gave this presentation at the American Health Lawyers Association, Institute on Medicare and Medicaid Payment Issues, Public Interest Session,in March 2012
Opportunities and Challenges for Comparative Effectiveness Pragmatic Clinical Trials in Europe
Donna Messner was part of this panel session at the 14th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research. Other participants were Marc L. Berger, David Price, and Finn B??rlum Kristensen.
Designing Better Comparative Effectiveness Research.
Donna Messner was a presenter at this workshop held during the 14th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR),
2010 CER Summit
A summary of the 2010 CER Summit which addressed building a strategic framework for research in oncology.
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.
Comparative Effectiveness Research Policy Brief (July 2010)
CMTP held a series of Policy Leadership Briefings in order to provide a neutral forum for key policy decision-makers and experts to engage in a frank and informative dialogue on critical CER issues, concerns and policy options. The first of these sessions focused on various aspects of CER, addressing questions on the differences between CER and traditional clinical research, methods by which CER studies should be carried out across the clinical research enterprise, as well as the critical factors necessary for the PCOR Institute to provide maximum value.
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.
Comparative Effectiveness Research: Background, Priorities, and Methods (July 2009)
Sean Tunis's presentation on July 10, 2009, served as an informative introduction to comparative effectiveness research.
Engaging Decision Makers in Comparative Effectiveness Research (June 2008)
Sean Tunis gave a presentation at the US Cochrane Center Conference on Priority Setting for Systematic Reviews on July 11, 2008.

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Comparative Effectiveness Research resources

Evaluating the comparative effectiveness of treatment sequences in oncology: a new approach

Demonstrating the Clinical Utility of Next Generation Sequencing in Clinical Oncology

The Current Drug Development Paradigm: Responding to US and European Demands for Evidence of Comparative Effectiveness and Relative Effectiveness

Stakeholder Defined Research: Designing Studies that reflect the perspectives of patients, clinicians and payers (February 2014)

Payer Perspectives on Improving Usability of Effective Health Care Products (February 2014)

Endocrine Metabolic Consortium Overview (Nov 2013)

COMET Initiative: Core outcome measures in effectiveness trials (Nov 2013)

Oncology Overview (2013)

EGD Overview (2014)

Development of an EGD for Patient Reported Outcomes in Oncology (May 2013)

Methodological Recommendations for Comparative Effectiveness Research on the Treatment of Chronic Wounds (October 2012)

Stakeholder Engagement in Comparative Effectiveness Research: How Will We Measure Success? (Sept 2012)

2011 CER Summit Report

Bending the Cost Curve Through Comparative Effectiveness Research (June 2012)

Recommendations for Incorporating Patient-Reported Outcomes into Clinical Comparative Effectiveness Research in Adult Oncology (May 2012)

Incorporating Stakeholder Perspectives In Developing a Translation Table Framework for Comparative Effectiveness Research (May 2012)

Methodological Guidance for Molecular Diagnostics Research in Oncology Workshop Slides May 2012

Comparative Effectiveness Research: What is it? Why do it? What 's Happening Now?

Opportunities and Challenges for Comparative Effectiveness Pragmatic Clinical Trials in Europe

Designing Better Comparative Effectiveness Research.

2010 CER Summit

Medicare Data United with Simple Clinical Trials Expanded (May 2011)

Comparative Effectiveness Research Policy Brief (July 2010)

MEDPAC Report (May 2010)

Comparative Effectiveness Research: Background, Priorities, and Methods (July 2009)

Engaging Decision Makers in Comparative Effectiveness Research (June 2008)