Coverage With Evidence Development and Managed Entry in the Funding of Personalized Medicine: Practical and Ethical Challenges for Oncology
| Autor: | Wendy Lipworth, Ian Kerridge, Jan R.R. Lewis |
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| Rok vydání: | 2015 |
| Předmět: |
Research design
Cancer Research medicine.medical_specialty Biomedical Research Technology Assessment Biomedical efficacy safety and cost effectiveness Cost effectiveness Cost-Benefit Analysis Decision Making Alternative medicine law.invention Randomized controlled trial law Research Support as Topic Humans Medicine Medical physics Precision Medicine funding new medicines Evidence-Based Medicine business.industry Evidence-based medicine Precision medicine ethics evidence development Oncology Research Design Personalized medicines Observational study Personalized medicine business |
| Zdroj: | Journal of Clinical Oncology. 33:4112-4117 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2015.61.2838 |
| Popis: | Personalized medicines hold promise for many diseases. However, demonstrating the clinical efficacy and cost effectiveness of these medicines can be difficult. It is essential that decision-making processes for funding new medicines, including personalized medicines, are both robust and fit for purpose. We will argue that randomized trials of personalized medicines should be routinely supplemented with other research methods, such as observational research and single-arm studies, and that managed-entry funding programs, such as coverage with evidence development, may offer a means of providing early access to technologies where there is uncertainty about efficacy, safety, and cost effectiveness. These programs, however, raise a number of practical and ethical challenges that need to be worked through and resolved. |
| Databáze: | OpenAIRE |
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