@article{c7b8137a367f4540a0718aaf2f95b954,
title = "Lupus community panel proposals for optimising clinical trials: 2018",
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.",
keywords = "clinical trials, outcome measures, trial design",
author = "Merrill, {Joan T.} and Susan Manzi and Cynthia Aranow and Anca Askenase and Ian Bruce and Eliza Chakravarty and Ben Chong and Karen Costenbader and Maria Dall'Era and Ellen Ginzler and Leslie Hanrahan and Ken Kalunian and Joseph Merola and Sandra Raymond and Brad Rovin and Amit Saxena and Werth, {Victoria P.}",
note = "Funding Information: Company, GSK group of companies, Xencor and Office of Minority Health. VPW received grant support from Celgene, Janssen, Biogen and Gilead. SM received grant support from BMS, AstraZeneca, HGS/GSK and Amgen. Funding Information: Competing interests JTM, MD Consultant: Anthera, Amgen, Baxalta, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb Company, Celgene Corporation, Eisai, EMD Serono; Exagen Diagnostics, Genentech, GSK, Gilead, ImmuPharma PLC, Horizon, Incyte, Janssen Pharmaceuticals; Mallinckrodt Pharmaceuticals, MedImmune/AstraZeneca, Neovacs SA, Pfizer, ReAlta, RRD International, Sanofi, Takeda Pharmaceuticals USA; UCB. VPW, MD Consultant: Resolve, Eli Lilly, Biogen, Idera, Medimmune, Genentech, BMS, Amgen, Penn own the copywright for the CLASI. IB MD, FRCP Research Support: Roche, GSK and Genzyme, and Sanofi Consulting/Speaker: Eli Lilly, AstraZeneca, GSK and UCB. IB is a National Institute for Health Research (NIHR) Senior Investigator and is funded by Arthritis Research UK, the Medical Research Council and the NIHR Manchester Biomedical Research Centre. BR MD Consultant: Alexion, Aurinia, Biogen, Biomarin, Bristol-Myers Squibb, EMB Serono, Fraizer, Genentech, Gilead, Eli Lilly, Lupus Foundation of America, Mallinckrodt, Pfizer, Pharmalink, Retrophin, Rigel, Trinity, Trinity Partners. JM MD, MMSc Consultant/Advisor: GSK and Biogen IDEC in Lupus indications. EG MD, MPH Consultant: Ablynx/PPDI Data Monitoring Board: Janssen Clinical Trial Investigator: Aurina, BMS, Genentech, GSK. CA MD Consultant: GSK Research Support: GlaxoSmithKline, EMD Serrono, Xencor, Takeda Pharmaceuticals and Janssen. BC MD Investigator: Daavin Corporation and Biogen. MD{\textquoteright}E MD Consultant: Kezar Abbvie Independent Data Monitoring Committee: Janssen Genentech Biogen. KK MD Consultant: Amgen, Eli Lilly, Genentech, Roche, BMS, Medimmune, AstraZeneca, Janssen, Xencor, Anthera, Exagen, Baxalta, Biogen Idec, Sorrento Therapeutics Grants/Contracts: NIH, Lupus Research Alliance, Sanford Regenerative Medicine Consortium, Pfizer, Ablynx, Resolve, Celgene, Takeda, Questcor, Proximagen, UCB, Gilead, Ampel, Kirin. KC MD MPH Consultant: AstraZeneca GSK Merck Research Collaborations: AstraZeneca GSK Merck. Research Support: NIH. SM MD, MPH Consultant: Exagen Diagnotics, Inc; GSK, UCB Advisory Board, Lupus Foundation of America (Medical Director), AstraZeneca (Advisory Board). patient consent None declared. provenance and peer review Not commissioned; externally peer reviewed. data sharing statement All data presented in this article are already published and are not in possession of the authors. open access This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/ licenses/by-nc/4.0/ {\textcopyright} Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. Funding Information: JTM received grant/research support from Bristol-Myers Squibb Company, GSK group of companies, Xencor and Office of Minority Health. VPW received grant support from Celgene, Janssen, Biogen and Gilead. SM received grant support from BMS, AstraZeneca, HGS/GSK and Amgen. Publisher Copyright: {\textcopyright} 2018 Article author(s).",
year = "2018",
doi = "10.1136/lupus-2018-000258",
language = "English (US)",
volume = "5",
journal = "Lupus Science and Medicine",
issn = "2053-8790",
publisher = "BMJ Publishing Group",
number = "1",
}