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medRxiv preprint doi: https://doi.org/10.1101/2025.02.12.25322124; this version posted February 13, 2025. The copyright holder for this preprint (which was not certified by peer review) is the author/funder,
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Clinical and cost-effectiveness refers to the evaluation of the benefits, risks, and economic value of a medical intervention, treatment, or service, comparing its effectiveness to alternatives.
Healthcare providers, pharmaceutical companies, and medical device manufacturers are typically required to file clinical and cost-effectiveness data to regulatory bodies and health technology assessment organizations.
To fill out clinical and cost-effectiveness assessments, one must gather data on clinical outcomes, economic analyses, patient demographics, and comparator interventions, and then present this data in a structured format as prescribed by the regulatory agency.
The purpose of clinical and cost-effectiveness evaluations is to ensure that healthcare interventions provide value for money while delivering safe and effective treatment options to patients.
Information that must be reported includes clinical trial results, health economic analyses, cost data, quality of life metrics, and comparative effectiveness data against existing standards of care.
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