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Guidelines for the preparation of E.O.R.T.C. cancer clinical trial protocols

par Staquet, Maurice ;Sylvester, Richard ;Jasmin, Claude
Référence European journal of cancer, 16, 6, page (871-875)
Publication Publié, 1980

Article révisé par les pairs

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Résumé :

A therapeutic clinical trial may be defined as a medical observation performed on patients in order to answer specific questions concerning new forms of treatment(s). The application of new therapeutic regimens to diseased persons requires ethical justification by means of experimental (animal), historical (literature), clinical (previous experience) and logical arguments. The written description of the objectives of the study, its rationale and logistics are contained in the "study protocol", a self-contained document. The goal of this paper is to provide an aid to investigators in the preparation of their protocols by means of guidelines (Table 1) which are discussed hereafter. These guidelines should be followed for all protocols submitted to the E.O.R.T.C. Protocol Review Committee∥ ∥ At this writing members are: P. Alberto (Geneva, Switzerland), G. Bonadonna (Milan, Italy), D. Crowther (Manchester, England), M. Hayat (Villejuif, France), J. L. Hayward (London, England), H. Heimpel (Ulm, W. Germany), J. E. Henney (Bethesda, Md, USA), C. Jasmin (Villejuif, France), Y. Kenis (Brussels, Belgium) M. Schlienger (Paris, France), M. Staquet (Brussels, Belgium), R. Sylvester (Brussels, Belgium), H. J. Tagnon (Brussels, Belgium), E. van der Schueren (Leuven, Belgium) and L. M. van Putten (Rijswijk, The Netherlands).. The design and analysis of cancer clinical trials are the subject of a number of publications [1-20] and will therefore not be discussed here. © 1980.