PMID: 8583540Aug 1, 1995Paper

Design of field trials for the evaluation of antibacterial products for therapy of bovine clinical mastitis

Journal of Veterinary Pharmacology and Therapeutics
Ynte H Schukken, H A Deluyker

Abstract

In this paper, the design and statistical analysis of field trials for the evaluation of the efficacy of clinical mastitis therapeutics is covered. First, general issues underlying the design of clinical trials are reviewed. These include bias and confounding; randomization and blocking; and study objectives and choice of the corresponding hypothesis. Specific issues in the design of clinical mastitis trials are also discussed. Selection of subjects is discussed with regard to choice of experimental units, identification of reference population and study population, inclusion and exclusion criteria, and sample size calculation. Next, a section on treatment administration and evaluation of cure reviews treatment, blinding, choice of response measure, as well as compliance, withdrawal, and early termination. The statistical analysis section addresses possible statistical models, treatment of confounding, and fixed vs. random effects. In conclusion, well-conducted clinical mastitis trials represent an invaluable, albeit difficult and expensive, effort to evaluate efficacy and tolerance under usual circumstances of use.

References

Mar 3, 1977·The New England Journal of Medicine·H Jick
Jul 15, 1989·The Veterinary Record·Y H SchukkenA Brand
Aug 1, 1988·The Journal of Dairy Research·S V MorantR P Natzke
Feb 22, 1986·The Veterinary Record·J W WilesmithC D Wilson
Aug 13, 2004·Journal of Veterinary Pharmacology and Therapeutics·T KutilaS Pyörälä

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Citations

Aug 14, 2001·Advanced Drug Delivery Reviews·P GruetV Kaltsatos
Jul 23, 1998·Journal of Veterinary Pharmacology and Therapeutics·M Shem-TovA Saran
Feb 18, 1998·Zentralblatt für Veterinärmedizin. Reihe A·M Shem-TovA Saran
Jul 22, 2004·Journal of Veterinary Medicine. A, Physiology, Pathology, Clinical Medicine·L HektoenS Larsen
May 18, 2013·Journal of Veterinary Pharmacology and Therapeutics·L SuojalaS Pyörälä
Oct 8, 2009·Journal of Veterinary Internal Medicine·J M SargeantK Snedeker
Jan 14, 2010·Journal of Homosexuality·Kristoff Bonello, Malcolm C Cross
Sep 26, 2019·Journal of Veterinary Pharmacology and Therapeutics·Andrew P Woodward, Ted Whittem

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