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Author Details

Sean Tunis
Center for Evaluation of Value and Risk in Health, Tufts Medical Center
1987
134
48
PMIDPaper TitleJournal TitlePublished Year
37074838Recommendations for economic evaluations of cell and gene therapies: a systematic literature review with critical appraisal.Expert Rev Pharmacoecon Outcomes Res2023
37579427What, Where, and How to Collect Real-World Data and Generate Real-World Evidence to Support Drug Reimbursement Decision-Making in Asia: A reflection Into the Past and A Way Forward.Int J Health Policy Manag2023
37644739Improving Food and Drug Administration-Centers for Medicare and Medicaid Services Coordination for Drugs Granted Accelerated Approval.Milbank Q2023
37602545Turning CMS into a Health Technology Assessment Organization.N Engl J Med2023
37325997Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group.Int J Technol Assess Health Care2023
35779824Review finds core outcome set uptake in new studies and systematic reviews needs improvement.J Clin Epidemiol2022
34763929Variation in market access decisions for cell and gene therapies across the United States, Canada, and Europe.Health Policy2021
33577156Proposed framework for patient-centered outcomes-based measures in alternative payment models.Am J Manag Care2021
32438026Controversy and Debate Series on Core Outcome Sets. Paper 3: Debate on Paper 1 from the perspective of GRADE [Grading of Recommendations Assessment, Development and Evaluation].J Clin Epidemiol2020
31775950Implementing health technology assessment in Ghana to support universal health coverage: building relationships that focus on people, policy, and process.Int J Technol Assess Health Care2020
33041164Erratum to "Controversy and debate series on core outcome sets. Paper 3:debate on paper 1 from the perspective of GRADE [Grading of Recommendations Assessment, Development and Evaluation]" [Journal of Clinical Epidemiology 125C (2020) 216-221].J Clin Epidemiol2020
32928330Real-world data for health technology assessment for reimbursement decisions in Asia: current landscape and a way forward.Int J Technol Assess Health Care2020
30744706Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement.Trials2019
31330522The Value of Diagnostic Information in Personalised Healthcare: A Comprehensive Concept to Facilitate Bringing This Technology into Healthcare Systems.Public Health Genomics2019
31371663Introduction.J Rheumatol2019
31198183Analytic Considerations in Applying a General Economic Evaluation Reference Case to Gene Therapy.Value Health2019
31129260The increasing complexity of the core outcomes landscape.J Clin Epidemiol2019
29438429Choosing important health outcomes for comparative effectiveness research: An updated systematic review and involvement of low and middle income countries.PLoS One2018
30086771Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 Diabetes (SCORE-IT): study protocol for the development of a core outcome set.Trials2018
29674586Insurance coverage for genomic tests.Science2018
29781145Core outcome set for gene therapy in haemophilia: Results of the coreHEM multistakeholder project.Haemophilia2018
28077228Levers for addressing medical underuse and overuse: achieving high-value health care.Lancet2017
31245580Stakeholder perspectives regarding alternate approaches to informed consent for comparative effectiveness research.Learn Health Syst2017
28406488Making genomic medicine evidence-based and patient-centered: a structured review and landscape analysis of comparative effectiveness research.Genet Med2017
28188898Rating of Included Trials on the Efficacy-Effectiveness Spectrum: development of a new tool for systematic reviews.J Clin Epidemiol2017
28159003The COMET Initiative database: progress and activities update (2015).Trials2017
29145404Core Outcome Set-STAndards for Development: The COS-STAD recommendations.PLoS Med2017
29140494Comparative Effectiveness Research in Integrative Oncology.J Natl Cancer Inst Monogr2017
28765256Engaging Stakeholders and Promoting Uptake of OMERACT Core Outcome Instrument Sets.J Rheumatol2017
27864388Payer Perspectives on Coverage of Biomarker Testing in Cardiovascular Disease.Clin Chem2017
26930026Patient and clinician support for the learning healthcare system: recommendations for enhancing value.J Comp Eff Res2016
26633547Generating and evaluating evidence of the clinical utility of molecular diagnostic tests in oncology.Genet Med2016
27755541Core Outcome Set-STAndards for Reporting: The COS-STAR Statement.PLoS Med2016
27487792Clinical interventions for venous leg ulcers: Proposals to improve the quality of clinical leg ulcer research.Wound Repair Regen2016
27070913Building Learning Health Systems to Accelerate Research and Improve Outcomes of Clinical Care in Low- and Middle-Income Countries.PLoS Med2016
26930385Improving the relevance and consistency of outcomes in comparative effectiveness research.J Comp Eff Res2016
25742674The views of quality improvement professionals and comparative effectiveness researchers on ethics, IRBs, and oversight.J Empir Res Hum Res Ethics2015
25669457From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.Clin Pharmacol Ther2015
24472114A national strategy to develop pragmatic clinical trials infrastructure.Clin Transl Sci2014
30235538Understanding the Role and Evidence Expectations of Health Technology Assessment and Coverage/Payer Bodies: What Are They Looking for, and How and Why Does This Differ From What Regulators Require?Ther Innov Regul Sci2014
25372702What can comparative effectiveness research contribute to integrative health in international perspective?J Altern Complement Med2014
25006877Accelerated access to innovative medicines for patients in need.Clin Pharmacol Ther2014
24856592Medical and pharmacy coverage decision making at the population level.J Manag Care Spec Pharm2014
24634466Evidence of clinical utility: an unmet need in molecular diagnostics for patients with cancer.Clin Cancer Res2014
24345252Interview: a 20-year 'search for evidence' leads to the Center for Medical Technology Policy.J Comp Eff Res2014
22955111Improving the efficiency and relevance of evidence-based recommendations in the era of whole-genome sequencing: an EGAPP methods update.Genet Med2013
24343113Lack of evidence for clinical and health policy decisions.BMJ2013
23903752Breaking a vicious cycle.Sci Transl Med2013
23919422Encouraging value-based insurance designs in state health insurance exchanges.Am J Manag Care2013
23999501Recommendations for the design of Phase 3 pharmaceutical trials that are more informative for patients, clinicians, and payers.Contemp Clin Trials2013
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Duke Clinical Research Institute, Duke University
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Epstein Health LLC
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