دورية أكاديمية
Why Evidence Generation Should Matter to Payers and How They Can Help.
| العنوان: | Why Evidence Generation Should Matter to Payers and How They Can Help. |
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| المؤلفون: | Abbasi AB; US Food and Drug Administration, Silver Spring, Maryland., Curtis LH; US Food and Drug Administration, Silver Spring, Maryland., Fleisher LA; University of Pennsylvania, Philadelphia., Califf RM; US Food and Drug Administration, Silver Spring, Maryland. |
| المصدر: | JAMA [JAMA] 2024 Aug 06; Vol. 332 (5), pp. 412-417. |
| نوع المنشور: | Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160 Publication Model: Print Cited Medium: Internet ISSN: 1538-3598 (Electronic) Linking ISSN: 00987484 NLM ISO Abbreviation: JAMA Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Chicago : American Medical Association, 1960- |
| مواضيع طبية MeSH: | Evidence-Based Medicine* , Product Surveillance, Postmarketing*/economics , Insurance, Health*/economics, Humans ; Clinical Trials as Topic ; United States ; United States Food and Drug Administration ; Insurance, Health, Reimbursement ; Private Sector |
| مستخلص: | Importance: The US leads the world in bringing new medical products to market, but the ability to generate evidence to inform clinical practice in postmarket settings needs improvement. Although a diverse group of stakeholders is working to improve postmarket evidence generation, the role of private payers has been underappreciated. Observations: Payers are crucial allies in improving evidence generation because better data would better inform coverage decisions, their policies and practices influence the conduct of care and research, and their claims data are a source of real-world evidence used in medical product evaluation. In addition, payers have a stake in improving evidence generation because the kinds of evidence needed to inform health care and coverage decisions are often not available when a product enters the market and may not be generated without their involvement. Here, we describe several key steps payers could take to improve evidence generation, including participating in efforts to reduce administrative and financial barriers to the conduct of clinical trials, directly incentivizing evidence generation on high-priority questions by funding potential cost-saving trials, increasing engagement with the medical products industry on evidentiary needs for coverage decisions, and improving usability of claims data by reducing data lags and routinely recording unique device identifiers. Broad payer engagement with US Food and Drug Administration recommendations regarding evidence generation will ensure that the opportunities to participate in clinical research are extended to all communities and that evidence needed to inform care is generated in trials and surveillance systems that reflect the clinical reality across the US. Conclusions and Relevance: Increasing payer involvement in evidence generation can benefit all participants in the medical innovation ecosystem. The importance of payers in these efforts will continue to grow in response to imperatives to increase integration of care and research, engage a diverse set of communities in clinical research, and move toward alternative payment models. |
| تواريخ الأحداث: | Date Created: 20240701 Date Completed: 20240806 Latest Revision: 20240828 |
| رمز التحديث: | 20240828 |
| DOI: | 10.1001/jama.2024.7616 |
| PMID: | 38949829 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1538-3598 |
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| DOI: | 10.1001/jama.2024.7616 |