US Food and Drug Administration's Directive to Deal With Delayed Confirmatory Trials: Lessons From Pralatrexate and Belinostat for T-Cell Lymphoma

Edward R.Scheffer Cliff; David A. Russler-Germain; C. Joseph Ross Daval; Aaron S. Kesselheim

doi:10.1200/JCO.24.00100

US Food and Drug Administration's Directive to Deal With Delayed Confirmatory Trials: Lessons From Pralatrexate and Belinostat for T-Cell Lymphoma

Edward R.Scheffer Cliff
, David A. Russler-Germain
, C. Joseph Ross Daval
, Aaron S. Kesselheim

Research output: Contribution to journal › Comment/debate

6 Scopus citations

Abstract

The FDA's directive to deal with delayed confirmatory trials: lessons from pralatrexate and belinostat for T-cell lymphoma.

Original language	English
Pages (from-to)	3901-3904
Number of pages	4
Journal	Journal of Clinical Oncology
Volume	42
Issue number	33
DOIs	https://doi.org/10.1200/JCO.24.00100
State	Published - Nov 20 2024

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10.1200/JCO.24.00100

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title = "US Food and Drug Administration's Directive to Deal With Delayed Confirmatory Trials: Lessons From Pralatrexate and Belinostat for T-Cell Lymphoma",

abstract = "The FDA's directive to deal with delayed confirmatory trials: lessons from pralatrexate and belinostat for T-cell lymphoma.",

author = "Cliff, \{Edward R.Scheffer\} and Russler-Germain, \{David A.\} and \{Joseph Ross Daval\}, C. and Kesselheim, \{Aaron S.\}",

year = "2024",

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AU - Cliff, Edward R.Scheffer

AU - Russler-Germain, David A.

AU - Joseph Ross Daval, C.

AU - Kesselheim, Aaron S.

PY - 2024/11/20

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N2 - The FDA's directive to deal with delayed confirmatory trials: lessons from pralatrexate and belinostat for T-cell lymphoma.

AB - The FDA's directive to deal with delayed confirmatory trials: lessons from pralatrexate and belinostat for T-cell lymphoma.

UR - https://www.scopus.com/pages/publications/85209828699

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DO - 10.1200/JCO.24.00100

M3 - Comment/debate

C2 - 39052948

AN - SCOPUS:85209828699

SN - 0732-183X

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JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

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ER -

US Food and Drug Administration's Directive to Deal With Delayed Confirmatory Trials: Lessons From Pralatrexate and Belinostat for T-Cell Lymphoma

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