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Arthritis Research & Therapy
Published in: Arthritis Research & Therapy 1/2009

01-02-2009 | Review

Randomized controlled trial design in rheumatoid arthritis: the past decade

Authors: Vibeke Strand, Jeremy Sokolove

Published in: Arthritis Research & Therapy | Issue 1/2009

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Abstract

Much progress has occurred over the past decade in rheumatoid arthritis trial design. Recognized challenges have led to the establishment of a clear regulatory pathway to demonstrate efficacy of a new therapeutic. The use of pure placebo beyond 12 to 16 weeks has been demonstrated to be unethical and thus background therapy and/or early rescue has become regular practice. Goals of remission and 'treating to targets' may prove more relevant to identify real-world use of new and existing therapeutics. Identification of rare adverse events associated with new therapies has resulted in intensive safety evaluation during randomized controlled trials and emphasis on postmarketing surveillance and use of registries.
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Metadata
Title
Randomized controlled trial design in rheumatoid arthritis: the past decade
Authors
Vibeke Strand
Jeremy Sokolove
Publication date
01-02-2009
Publisher
BioMed Central
Published in
Arthritis Research & Therapy / Issue 1/2009
Electronic ISSN: 1478-6362
DOI
https://doi.org/10.1186/ar2555

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