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Lupus community panel proposals for optimising clinical trials: 2018
Journal article   Open access   Peer reviewed

Lupus community panel proposals for optimising clinical trials: 2018

Joan T Merrill, Susan Manzi, Cynthia Aranow, Anca Askenase, Ian Bruce, Eliza Chakravarty, Ben Chong, Karen Costenbader, Maria Dall’Era, Ellen Ginzler, …
Lupus science & medicine, v 5(1), e000258
01 Jan 2018
PMID: 29657738
url
https://doi.org/10.1136/lupus-2018-000258View
Published, Version of Record (VoR) Open

Abstract

Formidable impediments stand in the way of treatment development for lupus. These include the unwieldy size of current trials, international competition for scarce patients, complex outcome measures and a poor understanding of these outcomes in the world at large. The heterogeneity of the disease itself coupled to superimposition of variegated background polypharmacy has created enough immunological noise to virtually ensure the failure of lupus treatment trials, leaving an understandable suspicion that at least some of the results in testing failed drugs over the years may not have been negative, but merely uninterpretable. The authors have consulted with many clinical trial investigators, biopharmaceutical developers and stakeholders from government and voluntary sectors. This paper examines the available evidence that supports workable trial designs and proposes approaches to improve the odds of completing interpretable treatment development programs for lupus.

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Collaboration types
Domestic collaboration
International collaboration
Web of Science research areas
Rheumatology
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