Senn, S. orcid.org/0000-0002-7558-8473 and Julious, S. orcid.org/0000-0002-9917-7636 (2009) Measurement in clinical trials: a neglected issue for statisticians? Statistics in Medicine, 28 (26). pp. 3189-3209. ISSN 0277-6715
Abstract
Biostatisticians have frequently uncritically accepted the measurements provided by their medical colleagues engaged in clinical research. Such measures often involve considerable loss of information. Particularly, unfortunate is the widespread use of the so-called ‘responder analysis’, which may involve not only a loss of information through dichotomization, but also extravagant and unjustified causal inference regarding individual treatment effects at the patient level, and, increasingly, the use of the so-called number needed to treat scale of measurement. Other problems involve inefficient use of baseline measurements, the use of covariates measured after the start of treatment, the interpretation of titrations and composite response measures. Many of these bad practices are becoming enshrined in the regulatory guidance to the pharmaceutical industry. We consider the losses involved in inappropriate measures and suggest that statisticians should pay more attention to this aspect of their work.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2009 John Wiley & Sons, Ltd. |
Keywords: | Biostatistics; Clinical Trials as Topic; Cross-Over Studies; Data Interpretation, Statistical; Electrocardiography; Humans; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic; Treatment Outcome |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Medicine and Population Health |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 06 Oct 2023 13:39 |
Last Modified: | 06 Oct 2023 13:39 |
Status: | Published |
Publisher: | Wiley |
Refereed: | Yes |
Identification Number: | 10.1002/sim.3603 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:204027 |