Article (Scientific journals)
How should zoster trials be conducted?
Wood, M. J.; Balfour, Hank; Beutner, Karl et al.
1995In Journal of Antimicrobial Chemotherapy, 36 (6), p. 1089-1101
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Abstract :
[en] In 1994, an international group of interested clinicians and biostatisticians met to discuss the design of clinical trials in herpes tester. They agreed that trials in herpes tester should have prospectively agreed definitions of all outcome measures and plans for data analysis. In immunocompetent individuals, in whom pain is the major outcome measure, trials should only include patients over the age of 50 years, and for those recruited within 72 fi of rash onset, should be designed to demonstrate superiority of any new therapy over existing antivirals. The primary endpoint should be time to cessation of pain for at least 4 weeks and, for the purposes of statistical analysis of its duration, the pain associated with herpes tester ought to be considered as a continuum. All other variables, including the incidence of post-herpetic neuralgia and effects upon quality of life should be considered as secondary end-points. Evaluation of treatment effects on primary endpoints should be based upon an intent-to-treat (ITT) analysis and subgroup analysis should be used only to support the findings of the ITT analysis. These elements of good study design should be borne in mind in the evaluation of current and future trails of antiviral drugs in herpes zoster.
Disciplines :
Microbiology
Immunology & infectious disease
Author, co-author :
Wood, M. J.
Balfour, Hank
Beutner, Karl
Bruxelle, Jean
Fiddian, Paul
Johnson, Robert
Kay, Richard
Cubed, S.
Portnoy, Joseph
Rentier, Bernard  ;  Université de Liège - ULiège > Département de Microbiologie > Virologie fondamentale et Immunologie
Whitley, Richard
Language :
English
Title :
How should zoster trials be conducted?
Publication date :
1995
Journal title :
Journal of Antimicrobial Chemotherapy
ISSN :
0305-7453
eISSN :
1460-2091
Publisher :
Oxford University Press
Volume :
36
Issue :
6
Pages :
1089-1101
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 13 February 2010

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