Individual Therapy: New Dawn or False Dawn?
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Individual Therapy: New Dawn or False Dawn? Stephen Senn Drug Information Journal 2001 35: 1479 DOI: 10.1177/009286150103500443 The online version of this article can be found at: http://dij.sagepub.com/content/35/4/1479
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Drug Information Journal, Vol. 35, pp. 1479-1494, 2001 Printed in the USA. All rights reserved.
0092-86 1 5/200 I Copyright 0 2001 Drug Information Association Inc.
INDIVIDUAL THERAPY: NEW DAWN OR FALSE DAWN? STEPHEN SENN,BA, MSc, PHD Professor of Pharmaceutical and Health Statistics, Departments of Epidemiology and Public Health and Statistical Science, University College London, London, United Kingdom
The sequencing of the human genome brings with it the hope that greater understanding of genetic components of disease will allow the more specific targeting of therapies. It has also been suggested that it will permit sponsors to run “cleaner” clinical trials with less variability and a consequent saving in patient numbers. Howevel; we do not know how much of the variation in response that we see from patient to patient in clinical trials is genetic, because we rarely design the sort of trials that would allow us to identify patient-by-treatment interaction. Such interaction provides an upper bound for gene-bytreatment interaction for a group of patients studied since patients differ by more than their genes. On the other hand, howevel; the variability seen within a clinical trial may generally be expected to be less than the total variation that would be seen within a population. There is a related statistical issue to do with the interpretation of effects from clinical trials. This arises because there is confusion between experimental and sampling models of clinical research. It is concluded that we may have to pay careful attention to certain design features of clinical trials if we wish to make progress in this field. Key Words: Patient-by-treatment interaction; Cross-over trials; n-of-1 trials; Effect sizes
INTRODUCTION “IT WILL SOON be possible for patients in clinical trials to undergo genetic tests to identify those individuals who will respond favourably to the drug candidate, based on their genotype, and therefore the underlying mechanism of their disease. This will translate into smaller, more effective clinical trials with corresponding cost savings and ultimately better treatment in general practice. In addition, clinical trials will be capable of screening for genes involved in the absorption,
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