Designing Late Phase Clinical Trials of Disease-modifying Agents to Delay or Prevent Dementia due to Alzheimer’s Disease

Posted November 6, 2018 by Donna Messner, PhD ,Jennifer Al Naber, MS, MSPH {categories}in{category_name}, {/categories}

This document reports on a project conducted by the Center for Medical Technology Policy’s Green Park Collaborative to create multi-stakeholder vetted recommendations for the design of studies in later phases of drug development to evaluate the ability of disease-modifying agents to delay or prevent the onset of dementia due to Alzheimer’s disease.

Core outcome set for gene therapy in haemophilia: Results of the coreHEM multistakeholder project

Posted May 21, 2018 by Elizabeth Clearfield, MHS ,Donna Messner, PhD ,Sean Tunis, MD, MSc {categories}in{category_name}, {/categories}

Iorio A, Skinner MW, Clearfield E, Messner D, Pierce GF, Witkop M, Tunis S; for the coreHEM panel. Core outcome set for gene therapy in haemophilia: Results of the coreHEM multistakeholder project. Haemophilia. 2018;00:1–6. https://doi.org/10.1111/hae.13504

coreHEM: Developing Comparative Effectiveness Outcomes for Gene Therapy in Hemophilia

Posted May 21, 2018 by Elizabeth Clearfield, MHS ,Donna Messner, PhD ,Sean Tunis, MD, MSc {categories}in{category_name}, {/categories}

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

Posted May 2, 2018 by Jennifer Al Naber, MS, MSPH ,Rachael Moloney, MHS ,Donna Messner, PhD ,Ellen Tambor, MA {categories}in{category_name}, {/categories}

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.

Paying for Cures: Perspectives on Solutions to the “Affordability Issue”

Posted March 1, 2018 by Donna Messner, PhD ,Ellen Tambor, MA {categories}in{category_name}, {/categories}

Karlsberg Schaffer S, Messner D, Mestre-Ferrandiz J, Tambor E, Towse A. Paying for Cures: Perspectives on Solutions to the ‘Affordability Issue.’ Value in Health 2018; 21: 276-279.

Core Clinical Data Elements for Cancer Genomic Repositories: A Multi-Stakeholder Consensus

Posted November 16, 2017 by Rob Conley, MD, JD, MPH ,Jennifer Al Naber, MS, MSPH ,Donna Messner, PhD {categories}in{category_name}, {/categories}

Conley RB, …, Al Naber J, Messner, DA, et al. Core Clinical Data Elements for Cancer Genomic Repositories: A Multi-Stakeholder Consensus. Cell 2017;171(5):982-986. doi.org/10.1016/j.cell.2017.10.032

Framing the conversation: use of PRECIS-2 ratings to advance understanding of pragmatic trial design domains.

Posted November 10, 2017 by Rachael Moloney, MHS ,Donna Messner, PhD {categories}in{category_name}, {/categories}

Lipman PD, Loudon K, Moloney R, Messner D, Stoney CM. Framing the conversation: use of PRECIS-2 ratings to advance understanding of pragmatic trial design domains. Trials 2017;18(1):532. doi. 10.1186/s13063-017-2267-y. PMID: 29126437

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

Posted November 1, 2015 by Donna Messner, PhD {categories}in{category_name}, {/categories}

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.

Futurescapes: Evidence expectations in Europe for comparative effectiveness research for drugs in 2020 (2015)

Posted March 2, 2015 by Donna Messner, PhD {categories}in{category_name}, {/categories}

Towse A, Garau M, Mohr P, Messner DA. Futurescapes: Evidence expectations in Europe for comparative effectiveness research for drugs in 2020. J Comp Eff Res. 2015;4(4):401-18. doi:10.2217/CER.15.7. PMID: 25740283. ISSN: 2042-6305.

Futurescapes: Evidence expectations in the USA for comparative effectiveness research for drugs in 2020 (2015)

Posted March 2, 2015 by Donna Messner, PhD {categories}in{category_name}, {/categories}

Messner DA, Mohr PE, Towse A. Futurescapes: Evidence expectations in the USA for comparative effectiveness research for drugs in 2020. J Comp Eff Res. 2015;4(4):385-400. doi:10.2217/CER.15.6. PMID: 25730709. ISSN: 2042-6305.

The future of comparative effectiveness and relative efficacy of drugs: an international perspective (2015)

Posted March 2, 2015 by Donna Messner, PhD {categories}in{category_name}, {/categories}

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

Posted November 7, 2014 by Donna Messner, PhD {categories}in{category_name}, {/categories}

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.

A Multi-stakeholder Agenda to Advance Enhanced Recovery for U.S. Surgical Patients

Posted October 9, 2014 by Rachael Moloney, MHS ,Rob Conley, MD, JD, MPH ,Donna Messner, PhD ,Sean Tunis, MD, MSc {categories}in{category_name}, {/categories}

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.

Oncology Consortium Update

Posted November 12, 2013 by Donna Messner, PhD {categories}in{category_name}, {/categories}

Progress Update on the GPC-USA Oncology Consortium presented at the 2014 Annual Meeting by Donna Messner, CMTP.

Electronic Consent: A Discussion of the eConsent Experience, Ethical and Regulatory Considerations, and the IRB Review Process

Posted November 7, 2013 by Donna Messner, PhD {categories}in{category_name}, {/categories}

Donna Messner participated in this presentation at the 2013 Advancing Ethical Conference. Her co-presenters were J. Andy Bertolatus and J. Claire Carbary.

Bariatric Surgery CED

Posted September 26, 2013 by Donna Messner, PhD {categories}in{category_name}, {/categories}

In February of 2013, CMTP hosted a stakeholder meeting of private payers, Maryland Medicaid representatives, a labor union, and self-insured employers. Participants discussed challenges and opportunities for Coverage with Evidence Development (CED) in connection with three cases: bariatric surgery, a diagnostic test, and interventions for autism.

Medicare Policy on Bariatric Surgery: Decision Making in the Face of Uncertainty (Sept 2013)

Posted September 12, 2013 by Sean Tunis, MD, MSc ,Donna Messner, PhD {categories}in{category_name}, {/categories}

Tunis SR, Messner DA. Medicare policy on bariatric surgery: decision making in the face of uncertainty. J Amer Med Assoc. 2013: doi:10.1001/jama.2013.278849

Evaluation of Clinical Validity and Utility of Actionable Molecular Diagnostic Tests in Adult Oncology (May 2013)

Posted May 1, 2013 by Donna Messner, PhD {categories}in{category_name}, {/categories}

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.

Incorporating Stakeholder Perspectives in Developing a Translation Table Framework for Comparative Effectiveness Research (December 2012)

Posted December 1, 2012 by Sean Tunis, MD, MSc ,Rachael Moloney, MHS ,Donna Messner, PhD {categories}in{category_name}, {/categories}

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.

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

Posted May 1, 2012 by Donna Messner, PhD ,Rachael Moloney, MHS ,Sean Tunis, MD, MSc {categories}in{category_name}, {/categories}

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.

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

Posted March 29, 2012 by Donna Messner, PhD {categories}in{category_name}, {/categories}

Donna Messner gave this presentation at the American Health Lawyers Association, Institute on Medicare and Medicaid Payment Issues, Public Interest Session,in March 2012

Current and Future State of FDA-CMS Parallel Reviews (March 2012)

Posted March 1, 2012 by Donna Messner, PhD {categories}in{category_name}, {/categories}

Messner, DA, Tunis, SR. Clin Pharmacol Ther. 2012;91(3), 383-385. doi: 10.1038/clpt.2011.350. PMID: 22343814

Making Informed Decisions: Assessing the Strengths and Weaknesses of Study Designs and Analytic Methods for Comparative Effectiveness Research: A Briefing Document for Stakeholders (Feb 2012)

Posted February 1, 2012 by Donna Messner, PhD {categories}in{category_name}, {/categories}

A Translation Table for Patient-centered Comparative Effectiveness Research — Guidance to Improve the Value of Research for Clinical and Health Policy Decision Making (January 2012)

Posted January 1, 2012 by Donna Messner, PhD ,Sean Tunis, MD, MSc {categories}in{category_name}, {/categories}

Tunis SR, Messner DA, Mohr PE, Gliklich RE, and Dubois RW. J Comp Eff Res. 2012;1(3), 259-262. doi: 10.2217/cer.12.22.

Opportunities and Challenges for Comparative Effectiveness Pragmatic Clinical Trials in Europe

Posted November 11, 2011 by Donna Messner, PhD {categories}in{category_name}, {/categories}

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 Børlum Kristensen.

Designing Better Comparative Effectiveness Research.

Posted November 7, 2011 by Donna Messner, PhD {categories}in{category_name}, {/categories}

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),