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Evidence Supporting FDA Approval and CMS National Coverage Determinations for Novel Medical Products, 2005 through 2016: A Cross-Sectional Study
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| 자료유형 | 학위논문 |
|---|---|
| 서명/저자사항 | Evidence Supporting FDA Approval and CMS National Coverage Determinations for Novel Medical Products, 2005 through 2016: A Cross-Sectional Study. |
| 개인저자 | Roginiel, Aliya C. |
| 단체저자명 | Yale University. Yale School of Medicine. |
| 발행사항 | [S.l.]: Yale University., 2019. |
| 발행사항 | Ann Arbor: ProQuest Dissertations & Theses, 2019. |
| 형태사항 | 43 p. |
| 기본자료 저록 | Dissertations Abstracts International 81-02A. Dissertation Abstract International |
| ISBN | 9781085557450 |
| 학위논문주기 | Thesis (M.D.)--Yale University, 2019. |
| 일반주기 |
Source: Dissertations Abstracts International, Volume: 81-02, Section: A.
Advisor: Ross, Joseph S. |
| 이용제한사항 | This item must not be sold to any third party vendors.This item must not be added to any third party search indexes. |
| 요약 | Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) rely on evidence from clinical trials when approving a therapeutic for marketing and insurance coverage in the US, respectively. No study has compared the quality and quantity of evidence examined by these agencies. Our purpose was to characterize evidence used by FDA and CMS to support marketing approval and coverage of novel therapeutics reviewed for CMS coverage from 2005 through 2016.We conducted a cross-sectional study of clinical trials described in FDA approval documents and CMS NCD memoranda. We compared the number of clinical trials used by each agency as well as the following characteristics of clinical trials: study size, randomization, double-blinding, and control arm. Twelve medical products met our inclusion criteria. FDA approvals were based on 22 pivotal trials. CMS NCDs were based on 27 original clinical trials |
| 일반주제명 | Medicine. Public policy. Public health. |
| 언어 | 영어 |
| 바로가기 | 
: 이 자료의 원문은 한국교육학술정보원에서 제공합니다. |
