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An international consensus panel on the potential value of Digital Surgery
Published 2024-09-01“…Delphi rounds were used to generate priority topics and consensus statements for discussion.Setting and participants An international panel of 14 experts was assembled, representing relevant stakeholder groups: clinicians, health economists, health technology assessment experts, policy-makers and industry.Primary and secondary outcome measures A scoping questionnaire was used to generate research questions to be answered. …”
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A policy framework for leveraging generative AI to address enduring challenges in clinical trials
Published 2025-01-01“…We introduce and propose the development of application-specific language models (ASLMs) for clinical trial design across three phases: ASLM development by regulatory agencies, customization by Health Technology Assessment bodies, and deployment to stakeholders. …”
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The Impact of Recent Generic Drug Price Policies on Pharmaceutical Innovation: A Theoretical Rationale and Proposal of a Method Supporting Innovation in Areas of Unmet Medical Need
Published 2016-10-01“…However, the use of fixed incremental cost-effectiveness (ICER) thresholds for health technology assessment (HTA) may compromise incentives to innovate and affect future treatment options. …”
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A Criterion-based Approach for the Systematic and Transparent Extrapolation of Clinical Trial Survival Data
Published 2015-02-01“…**Background:** Trial data often does not cover a sufficiently long period of time to truly capture time-toevent endpoints, however, Health Technology Assessment (HTA) bodies often require overall survival (OS) and progression-free survival (PFS) estimates. …”
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Funding the New Biologics – CCOHTA Report on the Cost Effectiveness of Infliximab for Crohn’s Disease: Pearls and Pitfalls
Published 2002-01-01“…The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) published an economic analysis, using a Markov model, of infliximab therapy for Crohn’s disease that is refractory to other treatments. …”
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Funding the New Biologics – A Health Economic Critique of the CCOHTA Report: Infliximab for the Treatment of Crohn’s Disease
Published 2002-01-01“…The report of the Canadian Coordinating Office for Health Technology Assessment (CCOHTA) on the use of infliximab in the treatment of refractory Crohn’s disease stated that the medication did not meet ‘conventional standards of cost-effectiveness’. …”
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HTA and Reimbursement Status of Metastatic Hormone‑Sensitive Prostate Cancer, Non-Metastatic Castration-Resistant Prostate Cancer, and Metastatic Castration-Resistant Prostate Canc...
Published 2023-06-01“…To improve decision-making regarding the value of anticancer therapies and support standardized assessment for use by health technology assessment (HTA) agencies, the European Society for Medical Oncology (ESMO) has developed a Magnitude of Clinical Benefit Scale (MCBS). …”
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Use of Healthcare Claims Data to Generate Real-World Evidence on Patients With Drug-Resistant Epilepsy: Practical Considerations for Research
Published 2024-02-01“…**Objectives:** Regulatory bodies, health technology assessment agencies, payers, physicians, and other decision-makers increasingly recognize the importance of real-world evidence (RWE) to provide important and relevant insights on treatment patterns, burden/cost of illness, product safety, and long-term and comparative effectiveness. …”
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Bibliometrics of NIHR HTA monographs and their related journal articles
Published 2015-02-01“…Objectives A bibliometric analysis of the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) monographs and their related journal articles by: (1) exploring the differences in citations to the HTA monographs in Google Scholar (GS), Scopus and Web of Science (WoS), and (2) comparing Scopus citations to the monographs with their related journal articles.Setting A study of 111 HTA monographs published in 2010 and 2011, and their external journal articles.Main outcome measures Citations to the monographs in GS, Scopus and WoS, and to their external journal articles in Scopus.Results The number of citations varied among the three databases, with GS having the highest and WoS the lowest; however, the citation-based rankings among the databases were highly correlated. …”
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Methods to appraise available evidence and adequacy of data from a systematic literature review to conduct a robust network meta-analysis of treatment options for patients with hos...
Published 2023-01-01“…Although this data is vital to registration, there are significant limitations in these trials for health technology assessments, payor decisions, guidelines, and protocol decisions.…”
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Systematic analysis of the pharmacogenomics landscape towards clinical implementation of precision therapeutics in Greece
Published 2025-02-01“…Here, we provide a comprehensive analysis of the current state of PGx in Greece, including a detailed allelic frequency spectrum of clinically actionable PGx biomarkers, the level of PGx education in academia, the provision of PGx testing services from public and private laboratories, and the aspects of the regulatory PGx environment, especially with respect to the discrepancies between the Greek National Organization of Medicines and the European Medicine Agency and health technology assessment. This study would not only provide the foundations for expediting the adoption of PGx in clinical reality in Greece but can also serve as a paradigm for replicating future studies in other European countries, to expand on previously available pilot studies.…”
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Use of Minimal Residual Disease Status to Reduce Uncertainty in Estimating Long-term Survival Outcomes for Newly Diagnosed Multiple Myeloma Patients
Published 2023-01-01“…**Discussion:** Alternative methods to estimate long-term survival outcomes, such as a response-based PSM, can reduce uncertainty in modeling predictions around cost-effectiveness estimates for health technology assessment bodies and payers, thereby supporting faster market access for novel therapies with immature survival data. …”
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