Data quality challenges in systemic lupus erythematosus trials: how can this be optimized?

Current Rheumatology Reports
Marilyn Pike, Lexy Kelley

Abstract

Major scientific advances in basic science, pharmacology, and translational medicine have allowed the discovery of new molecular targets whose manipulation by new chemical entities has led to treatments for inflammatory diseases, including rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease. Development of new agents for systemic lupus erythematosus (SLE) has lagged, however, because the protean manifestations of SLE present challenges for measuring therapeutic effects in a consistent manner. Composite end points combining several Disease Activity Indices (DAIs) are being used in ongoing global studies, but the uniform application of these complex DAIs across large numbers of clinical sites has proven difficult. We describe herein approaches that are being utilized to facilitate collection, review, and analysis of the clinical measures utilizing independent central adjudication committees.

References

Jun 1, 1991·Neurology·R OmdalG Husby
Mar 15, 2000·Burns : Journal of the International Society for Burn Injuries·T L WachtelH A Frank
Feb 24, 2001·Lupus·D A IsenbergUNKNOWN BILAG Group. British Isles Lupus Assessment Group
Jan 25, 2002·Current Controlled Trials in Cardiovascular Medicine·Kenneth W MahaffeyUNKNOWN For the PURSUIT Investigators
Mar 30, 2004·Brain : a Journal of Neurology·Dimos D MitsikostasPeter J Goadsby
Jun 14, 2008·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Laurent Peyrin-BirouletJean-Frédéric Colombel
Apr 28, 2009·Rheumatology·Chee-Seng YeeCaroline Gordon
May 5, 2009·The Journal of Clinical Investigation·Michael P CancroMunther A Khamashta
Aug 29, 2009·Arthritis and Rheumatism·Richard A FurieWilliam W Freimuth
Nov 17, 2009·Lupus·Z ToumaD D Gladman
May 22, 2010·The Oncologist·Ohad AmitDaniel Sargent
Oct 1, 2006·Expert Review of Pharmacoeconomics & Outcomes Research·Pantelis Panopalis, Ann E Clarke
Jan 12, 2011·British Journal of Clinical Pharmacology·Pawel Traczewski, Lidia Rudnicka
Nov 22, 2011·Respiratory Medicine·Lorcan P McGarveyDenis E Niewoehner
Jan 13, 2012·Annals of the New York Academy of Sciences·Mindy S Lo, George C Tsokos

❮ Previous
Next ❯

Citations

Jan 24, 2013·Expert Opinion on Biological Therapy·Zahi ToumaDafna D Gladman
Apr 8, 2016·Expert Opinion on Biological Therapy·Morton A ScheinbergRenee S Martin
Oct 16, 2015·Clinical Trials : Journal of the Society for Clinical Trials·Wenle Zhao, Keith Pauls

❮ Previous
Next ❯

Methods Mentioned

BETA
biopsy

Software Mentioned

iBLIPs
BILAG
BICLA
SELENA
EMBLEM

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.