Individual response to treatment: is it a valid assumption?
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《英国医生杂志》
1 Department of Statistics, University of Glasgow, Glasgow G12 8QQ stephen@stats.gla.ac.uk
Most drug trials assume that patients respond consistently to treatment, but the assumption is rarely tested. If patients vary randomly in their response to a drug rather than some patients never responding, searches for a genetic basis for non-response are futile
Introduction
Smith R. The drugs don't work . BMJ 2003:327(13 Dec). http://bmj.com/cgi/content/full/327/7428/0-h?
Guyatt GH, Juniper EF, Walter SD, Griffith LE, Goldstein RS. Interpreting treatment effects in randomised trials. BMJ 1998;316: 690-3.
Horwitz RI, Singer BH, Makuch RW, Viscoli CM. Can treatment that is helpful on average be harmful to some patients? A study of the conflicting information needs of clinical inquiry and drug regulation. J Clin Epidemiol 1996;49: 395-400.
Senn SJ, Harrell F. On wisdom after the event. J Clin Epidemiol 1997;50: 749-51.
Senn SJ, Harrell FE Jr. On subgroups and groping for significance. J Clin Epidemiol 1998;51: 1367-8.
Senn SJ. Individual therapy: new dawn or false dawn. Drug Info J 2001;35: 1479-94.
Kalow W, Tang BK, Endrenyi L. Hypothesis: comparisons of inter- and intra-individual variations can substitute for twin studies in drug research. Pharmacogenetics 1998;8: 283-9.
Senn SJ. Applying results of randomised trials to patients. N of 1 trials are needed. BMJ 1998;317: 537-8.
Senn SJ. Author 's reply to Walter and Guyatt. Drug Info J 2003;37: 7-10.(Stephen Senn, professor o)
Most drug trials assume that patients respond consistently to treatment, but the assumption is rarely tested. If patients vary randomly in their response to a drug rather than some patients never responding, searches for a genetic basis for non-response are futile
Introduction
Smith R. The drugs don't work . BMJ 2003:327(13 Dec). http://bmj.com/cgi/content/full/327/7428/0-h?
Guyatt GH, Juniper EF, Walter SD, Griffith LE, Goldstein RS. Interpreting treatment effects in randomised trials. BMJ 1998;316: 690-3.
Horwitz RI, Singer BH, Makuch RW, Viscoli CM. Can treatment that is helpful on average be harmful to some patients? A study of the conflicting information needs of clinical inquiry and drug regulation. J Clin Epidemiol 1996;49: 395-400.
Senn SJ, Harrell F. On wisdom after the event. J Clin Epidemiol 1997;50: 749-51.
Senn SJ, Harrell FE Jr. On subgroups and groping for significance. J Clin Epidemiol 1998;51: 1367-8.
Senn SJ. Individual therapy: new dawn or false dawn. Drug Info J 2001;35: 1479-94.
Kalow W, Tang BK, Endrenyi L. Hypothesis: comparisons of inter- and intra-individual variations can substitute for twin studies in drug research. Pharmacogenetics 1998;8: 283-9.
Senn SJ. Applying results of randomised trials to patients. N of 1 trials are needed. BMJ 1998;317: 537-8.
Senn SJ. Author 's reply to Walter and Guyatt. Drug Info J 2003;37: 7-10.(Stephen Senn, professor o)