| Original language | English (US) |
|---|---|
| Pages (from-to) | 912-914 |
| Number of pages | 3 |
| Journal | JAMA internal medicine |
| Volume | 180 |
| Issue number | 6 |
| DOIs | |
| State | Published - Jun 2020 |
ASJC Scopus subject areas
- Internal Medicine
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In: JAMA internal medicine, Vol. 180, No. 6, 06.2020, p. 912-914.
Research output: Contribution to journal › Letter › peer-review
}
TY - JOUR
T1 - FDA Acceptance of Surrogate End Points for Cancer Drug Approval
T2 - 1992-2019
AU - Chen, Emerson Y.
AU - Haslam, Alyson
AU - Prasad, Vinay
N1 - Funding Information: Conflict of Interest Disclosures: Dr Chen has received a lecture honorarium from Horizon CME. Dr Prasad reports research funding from Arnold Ventures; royalties from Johns Hopkins Press, Medscape; honoraria from grand rounds/lectures from universities, medical centers, nonprofit organizations, and professional societies; consulting fees from UnitedHealthcare; speaking fees from Evicore; and other support from Plenary Session podcast, which has Patreon backers. No other conflict of interest disclosures were reported. Funding/Support: This study was supported by Arnold Ventures (Haslam and Prasad). Role of the Funder/Sponsor: Arnold Ventures had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. 1. Kim C, Prasad V. Cancer drugs approved on the basis of a surrogate end point and subsequent overall survival: an analysis of 5 years of US Food and Drug Administration approvals. JAMA Intern Med. 2015;175(12):1992-1994. doi:10. 1001/jamainternmed.2015.5868 2. Kim C, Prasad V. Strength of validation for surrogate end points used in the US Food and Drug Administration’s approval of oncology drugs. Mayo Clin Proc. 2016;91(6)713-725. doi:10.1016/j.mayocp.2016.02.012 3. Gyawali B, Hey SP, Kesselheim AS. Assessment of the clinical benefit of cancer drugs receiving accelerated approval. JAMA Intern Med. 2019;179(7): 906-913. doi:10.1001/jamainternmed.2019.0462 4. Chen EY, Joshi SK, Tran A, Prasad V. Estimation of study time reduction using surrogate end points rather than overall survival in oncology clinical trials. JAMA Intern Med. 2019;179(5):642-647. doi:10.1001/jamainternmed. 2018.8351 5. Sun J, Wei Q, Zhou Y, Wang J, Liu Q, Xu H. A systematic analysis of FDA-approved anticancer drugs. BMC Syst Biol. 2017;11(suppl 5):87. doi:10.1186/ s12918-017-0464-7 6. Haslam A, Hey SP, Gill J, Prasad V. A systematic review of trial-level meta-analyses measuring the strength of association between surrogate end-points and overall survival in oncology. Eur J Cancer. 2019;106:196-211. doi:10.1016/j.ejca.2018.11.012
PY - 2020/6
Y1 - 2020/6
UR - http://www.scopus.com/inward/record.url?scp=85083704537&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85083704537&partnerID=8YFLogxK
U2 - 10.1001/jamainternmed.2020.1097
DO - 10.1001/jamainternmed.2020.1097
M3 - Letter
C2 - 32338703
AN - SCOPUS:85083704537
SN - 2168-6106
VL - 180
SP - 912
EP - 914
JO - JAMA internal medicine
JF - JAMA internal medicine
IS - 6
ER -