John Libbey Eurotext

Bulletin du Cancer


Increasing the quality of clinical trials in oncology: an important challenge Volume 90, issue 10, Octobre 2003

Unité de biostatistiques, Centre Val d‘Aurelle, Parc Euromédecine, 298, rue des Apothicaires, 34298 Montpellier Cedex 5 Département de chimiothérapie, Centre régional d‘oncologie, Lviv, Ukraine Département de Radiothérapie, CAC Antoine Lacassagne, Nice, France

The scientific literature publishes many articles reporting results of clinical trials. The criticisms which usually follow show the importance of the trial methodology in all of its aspects, since the results of these trials may have a strategic impact on the treatment of patients in the future. A clinical trial, no matter how many patients are included, will not have the anticipated impact if there are methodological biases. An inappropriate statistical analysis can always be redone, missing data can sometimes be retrieved, but a protocol not correctly followed or an inadequate strategy are fatal errors as far as the value of the conclusions of the trial are concerned. It is not ethical nowadays to start a clinical trial on humans if the results of the trials do not permit a conclusion because of methodological problems or inadequate resources. Each trial should thus be oriented in such a way so that each step is planned with an irreproachable quality by avoiding as much as possible methodological biases. The tendency today, which consists in adapting treatments more and more on an individual basis, will make it more difficult to undertake large simple clinical trials able to answer a simple question. Trials no longer escape the necessity to plan one or more interim analysis, since it is no longer ethical to continue to include patients without even thinking of looking at the results before the expected end of the trial, especially for severe adverse reactions. ▴