[An Introduction To the Statistical Design of Phase-iii Cancer Clinical-trials]
(1995) Der Urologe. Section A : Zeitschrift für klinische und praktische Urologie — Vol. 34, n° 5, p. 367-373 (1995)
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- Abstract
- A phase III clinical trial is a comparative study in which one assesses the relative efficacy of a treatment or treatments. It generally has one of the following objectives: 1. To determine the effectiveness of a new treatment relative to the natural history of the disease, for example when comparing a new treatment to not treatment or to placebo in an adjuvant setting. 2. To determine if a new treatment is more effective than the best current standard therapy (at the risk of increasing the toxicity). 3. To determine if a neu treatment is as effective as the best current standard therapy but is associated with less severe toxicity or a better quality of life (equivalence trial). Clinical trials must be properly designed in order to asnwer such questions with a high degree of certainty. The purpose of this paper is to present several concepts which must be taken into account during the process of designing a clinical trial.
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Citations
Sylvester, R. J., & Minder, CE. (1995). [An Introduction To the Statistical Design of Phase-iii Cancer Clinical-trials]. Der Urologe. Section A : Zeitschrift für klinische und praktische Urologie, 34(5), 367-373. https://hdl.handle.net/2078.5/144687 (Original work published 1995)