[Introduction to the statistical aspects of planning clinical oncologic phase III studies].
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.
D000368:Aged; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data*; D003131:Combined Modality Therapy; D003627:Data Interpretation, Statistical; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D009367:Neoplasm Staging; D011471:Prostatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D015996:Survival Rate; D016896:Treatment Outcome; D014565:Urogenital Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*
Eine Einführung in die statistischen Aspekte der Planung von klinischen onkologischen Studien der Phase III.