Role of phase 0 trials in drug development

James H. Doroshow; Shivaani Kummar

doi:10.4155/fmc.09.117

Role of phase 0 trials in drug development

James H. Doroshow, Shivaani Kummar

Research output: Contribution to journal › Comment/debate › peer-review

3 Scopus citations

Abstract

Phase 0 trials can provide proof of concept that an agent modulates its intended target without exposing patients to the drug-tolerability testing that precedes efficacy evaluation. Drugs that do not modulate their targets can be discarded, focusing development resources on the most clinically promising agents. However, wider uptake of Phase 0 trials may be hindered by ethical concerns over their lack of therapeutic intent, the substantial resources required to develop and validate target assays or skepticism that such trials save development time.

Original language	English (US)
Pages (from-to)	1375-1380
Number of pages	6
Journal	Future Medicinal Chemistry
Volume	1
Issue number	8
DOIs	https://doi.org/10.4155/fmc.09.117
State	Published - Nov 2009
Externally published	Yes

ASJC Scopus subject areas

Molecular Medicine
Pharmacology
Drug Discovery

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Role of phase 0 trials in drug development

Abstract

ASJC Scopus subject areas

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