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Lupus
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Early stopping of clinical trials in lupus and other uncommon rheumatologic diseases

Michael P LaValley

Multipurpose Arthritis and Musculoskeletal Diseases Center, Boston University, Boston, MA, USA; Department of Epidemiology and Biostatistics, School of Public Health, Boston University, Boston, MA, USA; Boston University Arthritis Center, 715 Albany Street, A203, Boston, MA 02118, USA Tel: (+1) (617) 638 5186; fax: (+1) (617) 638 5239

David T Felson

Multipurpose Arthritis and Musculoskeletal Diseases Center, Boston University, Boston, MA, USA; Department of Epidemiology and Biostatistics, School of Public Health, Boston University, Boston, MA, USA

Use of statistical methods for early stopping of clinical trials allows more efcient and ethical utilization of subjects. In uncommon diseases, where the pool of potential subjects is limited, these methods provide a way to maximize the information gathered from trials. For trials in lupus, methods for early stopping should be more widely utilized. We discuss the ethics, practical aspects, pros and cons, and statistical foundations of some established methods for early stopping, with an emphasis on those that have available implementation in computer software. An example of the design and analysis of a treatment trial in systemic lupus erythematosus with the triangular test method of early stopping is also given.

Key Words: RCT • DSMB • interim monitoring • statistics • triangular test

Lupus, Vol. 8, No. 8, 698-703 (1999)
DOI: 10.1191/096120399680411380
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