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

Curr Rheumatol Rep. 2012 Aug;14(4):324-33. doi: 10.1007/s11926-012-0261-7.


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.

Publication types

  • Review

MeSH terms

  • Clinical Trials as Topic / methods
  • Clinical Trials as Topic / standards*
  • Humans
  • Immunologic Factors / therapeutic use
  • Lupus Erythematosus, Systemic / drug therapy*
  • Molecular Targeted Therapy / methods
  • Research Design / standards*
  • Severity of Illness Index


  • Immunologic Factors