Lessons from TGN1412 and TARGET:implications for observational studies and meta-analysis

Senn, S. (2008) Lessons from TGN1412 and TARGET:implications for observational studies and meta-analysis. Pharmaceutical Statistics, 7(4), pp. 294-301. (doi: 10.1002/pst.322)

Abstract

Two very different studies are examined: the first, a very large trial in osteoarthritis (the so-called TARGET study) and the second a very small 'first-in-man' study of the monoclonal antibody TGN1412. In each trial the unbiased estimate of the treatment effect is not efficient and in consequence the efficient estimate is not unbiased. In the case of the large trial it seems reasonable that unbiased estimation is desirable but in the case of the small trial it leads to absurd conclusions. These two cases are examined in detail and some general lessons for the analysis of clinical trials and observational studies and collections of studies are drawn.

• Item Type: Articles
• Keywords: Veiled trial, bias, variance, mean square error, concurrent control.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Senn, Professor Stephen
• Authors: Senn, S.
• Subjects: H Social Sciences > HA Statistics
• College/School: College of Science and Engineering > School of Mathematics and Statistics > Statistics
• Journal Name: Pharmaceutical Statistics
• ISSN: 1539-1604