Design considerations and analysis planning of a phase 2a proof of concept study in rheumatoid arthritis in the presence of possible non-monotonicity

Design considerations and analysis planning of a phase 2a proof of concept study in rheumatoid arthritis in the presence of possible non-monotonicity

Abstract Background It is important to quantify the dose response for a drug in phase 2a clinical trials so the optimal doses can then be selected for subsequent late phase trials. In a phase 2a clinical trial of new lead drug being developed for the treatment of rheumatoid arthritis (RA), a U-shape...

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Bibliographic Details
Main Authors: Feng Liu, Stephen J. Walters, Steven A. Julious
Format: Article
Language:English
Published: BMC 2017-10-01
Series:BMC Medical Research Methodology
Subjects:
Emax
NDLM
Dose response
Bayesian
Rheumatoid arthritis
Online Access:http://link.springer.com/article/10.1186/s12874-017-0416-3

Internet

http://link.springer.com/article/10.1186/s12874-017-0416-3

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