E. Genevois et al., STUDY DESIGN, METHODOLOGY AND STATISTICAL-ANALYSES IN THE CLINICAL DEVELOPMENT OF SPARFLOXACIN, Journal of antimicrobial chemotherapy, 37, 1996, pp. 65-72
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.