STUDY DESIGN, METHODOLOGY AND STATISTICAL-ANALYSES IN THE CLINICAL DEVELOPMENT OF SPARFLOXACIN

Many publications in the past 10 years have emphasised the difficultie s of evaluating anti-infective drugs and the need for well-designed cl inical trials in this therapeutic field. The clinical development of s parfloxacin in Europe, involving more than 4000 patients in ten countr ies, provided the opportunity to implement a methodology for evaluatio n and statistical analyses which would take into account actual requir ements and past insufficiencies. This methodology focused on a rigorou s and accurate patient classification for evaluability, subgroups of p articular interest, efficacy assessment based on automation (algorithm ) and individual case review by expert panel committees. In addition, the statistical analyses did not use significance testing but rather c onfidence intervals to determine whether sparfloxacin was therapeutica lly equivalent to the reference comparator antibacterial agents.