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dc.contributor.authorMerrill, Joan T
dc.contributor.authorManzi, Susan
dc.contributor.authorAranow, Cynthia
dc.contributor.authorAskanase, Anca
dc.contributor.authorBruce, Ian
dc.contributor.authorChakravarty, Eliza
dc.contributor.authorChong, Ben
dc.contributor.authorCostenbader, Karen
dc.contributor.authorDall'Era, Maria
dc.contributor.authorGinzler, Ellen
dc.contributor.authorHanrahan, Leslie
dc.contributor.authorKalunian, Ken
dc.contributor.authorMerola, Joseph
dc.contributor.authorRaymond, Sandra
dc.contributor.authorRovin, Brad
dc.contributor.authorSaxena, Amit
dc.contributor.authorWerth, Victoria P
dc.date.accessioned2023-02-07T18:12:33Z
dc.date.available2023-02-07T18:12:33Z
dc.date.issued2018-03-23
dc.identifier.citationMerrill JT, Manzi S, Aranow C, Askanase A, Bruce I, Chakravarty E, Chong B, Costenbader K, Dall'Era M, Ginzler E, Hanrahan L, Kalunian K, Merola J, Raymond S, Rovin B, Saxena A, Werth VP. Lupus community panel proposals for optimising clinical trials: 2018. Lupus Sci Med. 2018 Mar 23;5(1):e000258. doi: 10.1136/lupus-2018-000258. Erratum in: Lupus Sci Med. 2018 Jun 11;5(1):e000258corr1. PMID: 29657738; PMCID: PMC5894527.en_US
dc.identifier.issn2053-8790
dc.identifier.doi10.1136/lupus-2018-000258
dc.identifier.pmid29657738
dc.identifier.urihttp://hdl.handle.net/20.500.12648/8297
dc.description.abstractFormidable 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.
dc.language.isoenen_US
dc.relation.urlhttps://lupus.bmj.com/content/5/1/e000258.longen_US
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectclinical trialsen_US
dc.subjectoutcome measuresen_US
dc.subjecttrial designen_US
dc.titleLupus community panel proposals for optimising clinical trials: 2018.en_US
dc.typeArticle/Reviewen_US
dc.source.journaltitleLupus science & medicineen_US
dc.source.volume5
dc.source.issue1
dc.source.beginpagee000258
dc.source.endpage
dc.source.countryUnited Kingdom
dc.source.countryEngland
dc.description.versionVoRen_US
refterms.dateFOA2023-02-07T18:12:34Z
html.description.abstractFormidable 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.
dc.description.institutionSUNY Downstateen_US
dc.description.departmentRheumatologyen_US
dc.description.degreelevelN/Aen_US
dc.identifier.journalLupus science & medicine


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