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The methodology for conducting cancer clinical trials has undergone enormous changes over the past 25-30 years since the EORTC Data Center was created. The purpose of this paper is to highlight and to provide a historical perspective for the main methodological concepts, both practical and theoretical, which form the basis for the design and analysis of phase III cancer clinical trials within the EORTC Data Center. Some statistical aspects of other associated topics such as quality of life, health economics, meta-analysis and treatment outcome will also be briefly discussed. Finally, some future perspectives and topics for further statistical methodological research will be presented in order to spur statisticians to meet the challenge of efficiently designing and analysing the clinical trials of tomorrow.

Original publication

DOI

10.1016/s0959-8049(01)00442-7

Type

Journal article

Journal

European journal of cancer (Oxford, England : 1990)

Publication Date

03/2002

Volume

38 Suppl 4

Pages

S162 - S168

Addresses

EORTC Data Center, 83 avenue E Mounier, Bte 11, 1200, Brussels, Belgium. rsy@eortc.be

Keywords

Humans, Research Design, Patient Selection, Forecasting, Statistics as Topic, Meta-Analysis as Topic, Randomized Controlled Trials as Topic, Clinical Trials, Phase III as Topic