Strength of clinical evidence supporting the United States Food and Drug Administration Accelerated Approvals from 2015 to 2022
The number of drug-indication pairs receiving AA increased sharply during 2015-2016 to 2019-2020 but fell in 2021-2022. Meanwhile, the strength of clinical evidence supporting FDA's AAs appeared to decline from 2015 to 2020 but seems to have improved in 2021-2022. Measures should be taken to further improve the strength of evidence in Accelerated Approvals.
Authors
- Yangfeng Wu (ORCID: https://orcid.org/0000-0002-4451-1932)
- Thomas D. Szucs (ORCID: https://orcid.org/0000-0003-0195-3316)
- Carl C. Peck (ORCID: https://orcid.org/0000-0003-0196-9668)
- Xue Bai (ORCID: https://orcid.org/0000-0001-9283-3015)
- Fengzhi Wang (ORCID: https://orcid.org/0009-0001-4859-3875)
- Siyu Chen (ORCID: https://orcid.org/0000-0002-3809-1062)
- Yaning Wang (ORCID: https://orcid.org/0000-0002-2503-2821)
- Xiaofang Zhang (ORCID: https://orcid.org/0000-0001-9757-514X)
- Wan Sun
Institutions
- University of California, San Francisco (US)
- University of Basel (CH)
- Peking University (CN)
- China National Biotechnology (China) (CN)
- Chinese Institute for Brain Research (CN)
- Peking University First Hospital (CN)
- DGA Partners (US)
Publication Details
- Journal
- BMC Medicine
- Published
- 2024-12-18
- DOI
- https://doi.org/10.1186/s12916-024-03800-6
- Citations
- 1
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 1.13
Funders
- Clinical Trial Center, China Medical University Hospital
- Peking University
- Peking University Third Hospital