Measuring meaningful change in lupus clinical trials - BioMed Central [PDF]

Measuring meaningful change in lupus clinical trials. Edited by: Matthew Liang and Chan-Bum Choi. This series of article

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Measuring meaningful change in lupus clinical trials Edited by: Matthew Liang and Chan-Bum Choi This series of articles has not been sponsored. All articles have undergone the journal’s standard peer review process overseen by the Series Editors, with final decisions made by the Editorsin-Chief. The Series Editors and Editors-in-Chief declare no competing interests. 1. Content type: Review

Progress in defining clinically meaningful changes for clinical trials in nonrenal manifestations of SLE disease activity Since the 2002 Dusseldorf meeting, one new agent, Benlysta, has been approved by the US Food and Drug Administration for systemic lupus erythematosus. Experiences from the field in conducting trials of all the... Authors: Chan-Bum Choi, Matthew H. Liang and Sang-Cheol Bae Citation: Arthritis Research & Therapy 2016 18:1 Published on: 6 January 2016 View Full Text View PDF 2. Content type: Review

Statistical considerations for stopping systemic lupus erythematosus clinical trials earlier Group sequential designs are used to potentially shorten randomized clinical trials and thereby reduce subject burden, improve safety, and save time and resources. Clinical trials comparing treatments for syst... Authors: Robert A. Lew, Matthew H. Liang and Gheorghe Doros Citation: Arthritis Research & Therapy 2015 17:345 Published on: 4 December 2015 View Full Text View PDF 3. Content type: Review

Measuring disease activity in adults with systemic lupus erythematosus: the challenges of administrative burden and responsiveness to patient concerns in clinical research Measuring lupus disease activity accurately remains a challenging and demanding task given the complex multi-system nature of lupus, an illness known for its variability between patients and within the same pa... Authors: Jamal Mikdashi and Ola Nived Citation: Arthritis Research & Therapy 2015 17:183 Published on: 20 July 2015 View Full Text View PDF 4. Content type: Review

Approaches for estimating minimal clinically important differences in systemic lupus erythematosus A minimal clinically important difference (MCID) is an important concept used to determine whether a medical intervention improves perceived outcomes in patients. Prior to the introduction of the concept in 19... Authors: Sharan K Rai, Jinoos Yazdany, Paul R Fortin and J Antonio Aviña-Zubieta Citation: Arthritis Research & Therapy 2015 17:143

Published on: 3 June 2015 View Full Text View PDF 5. Content type: Review

Comparison and evaluation of lupus nephritis response criteria in lupus activity indices and clinical trials Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with diverse manifestations. Although the approval of new therapies includes only one agent in 50 years, a number of promising new drugs are ... Authors: Kristin M Corapi, Mary Anne Dooley and William F Pendergraft III Citation: Arthritis Research & Therapy 2015 17:110 Published on: 28 April 2015 View Full Text View PDF Advertisement

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