Measurement in clinical trials: A neglected issue for statisticians? Export

@article{senn-2009, 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 lsquoresponder analysisrsquo, 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. Copyright {\copyright} 2009 John Wiley \& Sons, Ltd.}, address = {Department of Statistics, University of Glasgow, Glasgow G12 9LL, U.K.; University of Sheffield, Sheffield, U.K.}, author = {Senn, Stephen and Julious, Steven}, citeulike-article-id = {5997196}, citeulike-linkout-0 = {http://dx.doi.org/10.1002/sim.3603}, citeulike-linkout-1 = {http://www3.interscience.wiley.com/cgi-bin/abstract/122379200/ABSTRACT}, doi = {10.1002/sim.3603}, issn = {1097-0258}, journal = {Statistics in Medicine}, keywords = {accuracy, clinical, measurement, scharr, statistics, trial}, number = {26}, pages = {3189--3209}, posted-at = {2009-10-23 11:08:56}, priority = {2}, title = {Measurement in clinical trials: A neglected issue for statisticians?}, url = {http://dx.doi.org/10.1002/sim.3603}, volume = {28}, year = {2009} }

TY - JOUR ID - senn-2009 L3 - citeulike-article-id:5997196 N2 - 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 lsquoresponder analysisrsquo, 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. Copyright © 2009 John Wiley & Sons, Ltd. IS - 26 JF - Statistics in Medicine SN - 1097-0258 AD - Department of Statistics, University of Glasgow, Glasgow G12 9LL, U.K.; University of Sheffield, Sheffield, U.K. EP - 3209 TI - Measurement in clinical trials: A neglected issue for statisticians? VL - 28 SP - 3189 KW - accuracy KW - clinical KW - measurement KW - scharr KW - statistics KW - trial AU - Senn, Stephen AU - Julious, Steven PY - 2009/// UR - http://dx.doi.org/10.1002/sim.3603 ER -