Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017 | Zendy

Audrey D. Zhang | Zendy; Jeremy Puthumana | Zendy; Nicholas S. Downing | Zendy; Nilay D. Shah | Zendy; Harlan M. Krumholz | Zendy; Joseph S. Ross | Zendy

Open Access

Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017

Author(s) -

Audrey D. Zhang,

Jeremy Puthumana,

Nicholas S. Downing,

Nilay D. Shah,

Harlan M. Krumholz,

Joseph S. Ross

Publication year - 2020

Publication title -

jama network open

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 3.278

H-Index - 39

ISSN - 2574-3805

DOI - 10.1001/jamanetworkopen.2020.3284

Subject(s) - medicine , food and drug administration , clinical trial , drug approval , blinding , bioequivalence , orphan drug , drug , approved drug , pharmacology , pharmacokinetics , bioinformatics , biology

Key Points Question Have the number and characteristics of pivotal efficacy trials supporting US Food and Drug Administration approval of new drugs and biologics changed during the past 3 decades? Findings In this cross-sectional study of 273 new drugs and biologics approved by the Food and Drug Administration for 339 indications in 3 periods (1995-1997, 2005-2007, and 2015-2017), more recent approvals increasingly used special regulatory programs and were based on fewer pivotal trials. When aggregated by indication, these trials had less rigorous designs but longer trial durations over time. Meaning This study found changes in the evidence supporting Food and Drug Administration approval of new drugs and biologics that suggest an ongoing need for continued evaluation of therapeutic safety and efficacy after approval.

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