Measurement in clinical trials: a neglected issue for statisticians?

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.

journal_name

Stat Med

journal_title

Statistics in medicine

authors

Senn S,Julious S

doi

10.1002/sim.3603

subject

Has Abstract

pub_date

2009-11-20 00:00:00

pages

3189-209

issue

26

eissn

0277-6715

issn

1097-0258

journal_volume

28

pub_type

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