Stronger correlation of surrogate endpoints with survival needed

Stronger correlation of surrogate endpoints with survival needed

"For 56% of accelerated approvals (14/25) and 37% of traditional approvals (11/30), there is no study in the entire biomedical literature showing how robust that surrogate is," Prasad said. [...]only ten (18%) of these 55 approvals were later found to have an overall survival benefit--15 (...

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Veröffentlicht in:The lancet oncology 2016-07, Vol.17 (7), p.e273-e273
1. Verfasser: Carlson, Robert H
Format: Artikel
Sprache:eng
Schlagworte:
FDA approval
Hematology, Oncology and Palliative Medicine
Marketing
Prescription drugs
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Zusammenfassung:"For 56% of accelerated approvals (14/25) and 37% of traditional approvals (11/30), there is no study in the entire biomedical literature showing how robust that surrogate is," Prasad said. [...]only ten (18%) of these 55 approvals were later found to have an overall survival benefit--15 (27%) did not improve overall survival, and 30 (55%) still have not undergone post-marketing testing.
ISSN:1470-2045
1474-5488
DOI:10.1016/S1470-2045(16)30210-8