TY - JOUR
T1 - Investigating variability in patient response to treatment - A case study from a replicate cross-over study
AU - Senn, Stephen
AU - Rolfe, Katie
AU - Julious, Steven A.
N1 - Publisher Copyright:
© SAGE Publications.
PY - 2011/12
Y1 - 2011/12
N2 - It is a common belief that individual variation in response to treatment is an important explanation for the variation in observed outcomes in clinical trials. If such variation is large, it seems reasonable to suppose that progress in treating disease will be advanced by classifying patients according to their abilities or not to 'respond' to particular treatments. We consider that there is currently a lost opportunity in drug development. There is a great deal of talk about individual response to treatment and tailor-made drugs. However, relatively little work is being done to formally investigate, using suitable designs, where individual response to treatment may be important. Through a case study from a replicate cross-over study we show how, given suitable replication, it is possible to isolate the component of variation corresponding to patient-by-treatment interaction and hence investigate the possibility of individual response to treatment.
AB - It is a common belief that individual variation in response to treatment is an important explanation for the variation in observed outcomes in clinical trials. If such variation is large, it seems reasonable to suppose that progress in treating disease will be advanced by classifying patients according to their abilities or not to 'respond' to particular treatments. We consider that there is currently a lost opportunity in drug development. There is a great deal of talk about individual response to treatment and tailor-made drugs. However, relatively little work is being done to formally investigate, using suitable designs, where individual response to treatment may be important. Through a case study from a replicate cross-over study we show how, given suitable replication, it is possible to isolate the component of variation corresponding to patient-by-treatment interaction and hence investigate the possibility of individual response to treatment.
KW - components of variation
KW - personalised medicine
KW - replicate cross-over
KW - treatment response
KW - within subject variability
UR - http://www.scopus.com/inward/record.url?scp=84555192592&partnerID=8YFLogxK
U2 - 10.1177/0962280210379174
DO - 10.1177/0962280210379174
M3 - Article
C2 - 20739334
AN - SCOPUS:84555192592
SN - 0962-2802
VL - 20
SP - 657
EP - 666
JO - Statistical Methods in Medical Research
JF - Statistical Methods in Medical Research
IS - 6
ER -