RECOMMENDATIONS FOR THE APPLICATION OF BIOSTATISTICAL METHODS DURING THE DEVELOPMENT AND VALIDATION OF ALTERNATIVE TOXICOLOGICAL METHODS - ECVAM BIOSTATISTICS TASK-FORCE REPORT 1

Assessment of the relevance and reliability of alternative toxicologic al methods requires the application of biostatistical methods. This re port contains the recommendations of the ECVAM Task Force on Biostatis tics for the appropriate use of biometrical methods, and for closer co llaboration between biostatisticians and experimental toxicologists in the development and validation of alternative methods. The main objec tives of these recommendations are to improve the compatibility of the results obtained from different studies, and to prevent the misinterp retation of statistical analyses. The following points are discussed: a) the general importance of biostatistics in the development and vali dation of alternative tests; b) optimisation of study designs; c) stat istical characterisation and processing of toxicological data; and d) the analysis of relationships which may exist between data obtained fr om various tests. In particular, the establishment of appropriate pred iction models which are able to predict the toxic effects likely to oc cur in vivo from the results obtained in an in vitro test system is di scussed. The members of the Task Force hope that this report will help to stimulate discussions among biostatisticians and experimental toxi cologists about how the proper application of biostatistical methods c an improve the design and evaluation of alternative toxicological meth ods.