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[Introduction to the statistical aspects of planning clinical oncologic phase III studies].
- Source :
-
Der Urologe. Ausg. A [Urologe A] 1995 Sep; Vol. 34 (5), pp. 367-73. - Publication Year :
- 1995
-
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 new 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 answer 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.
- Subjects :
- Aged
Combined Modality Therapy
Data Interpretation, Statistical
Humans
Male
Middle Aged
Multicenter Studies as Topic statistics & numerical data
Neoplasm Staging
Prostatic Neoplasms mortality
Prostatic Neoplasms pathology
Prostatic Neoplasms therapy
Quality of Life
Survival Rate
Treatment Outcome
Urogenital Neoplasms mortality
Urogenital Neoplasms pathology
Clinical Trials, Phase III as Topic statistics & numerical data
Randomized Controlled Trials as Topic statistics & numerical data
Urogenital Neoplasms therapy
Subjects
Details
- Language :
- German
- ISSN :
- 0340-2592
- Volume :
- 34
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Der Urologe. Ausg. A
- Publication Type :
- Academic Journal
- Accession number :
- 7483152