caa a22 4500 397592981 CHVBK 20180308164944.0 cr unu---uuuuu 161202e199605 xx s 000 0 eng 10.1093/jac/37.suppl_A.65 doi (NATIONALLICENCE)oxford-10.1093/jac/37.suppl_A.65 Study design, methodology and statistical analyses in the clinical development of sparfloxacin [Elektronische Daten] [E. Genevois, V. Lelouer, Jean-Baptiste Vercken, R. Caillon] Many publications in the past 10 years have emphasised the difficulties of evaluating anti-infective drugs and the need for well-designed clinical trials in this therapeutic field. The clinical development of sparfloxacin in Europe, involving more than 4000 patients in ten countries, provided the opportunity to implement a methodology for evaluation and statistical analyses which would take into account actual requirements and past insufficiencies. This methodology focused on a rigorous and accurate patient classification for evaluability, subgroups of particular 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 confidence intervals to determine whether sparfloxacin was therapeutically equivalent to the reference comparator antibacterial agents. © 1996 The British Society for Antimicrobial Chemotherapy Articles nationallicence Genevois E. Rhône-Poulenc Rorer Central Research, Biostatistics Department 500 Arcola Road, Collegeville PA 19426, USA aut Lelouer V. Rhône D. P. C. Europe 20 Av R. Aron, 92165, Antony Cedex, France aut Vercken Jean-Baptiste Rhône D. P. C. Europe 20 Av R. Aron, 92165, Antony Cedex, France aut Caillon R. Rhône D. P. C. Europe 20 Av R. Aron, 92165, Antony Cedex, France aut Journal of Antimicrobial Chemotherapy Oxford University Press 37(1996-05), 65-72 0305-7453 37<65 1996 37 jac https://doi.org/10.1093/jac/37.suppl_A.65 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1093/jac/37.suppl_A.65 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Genevois E. Rhône-Poulenc Rorer Central Research, Biostatistics Department 500 Arcola Road, Collegeville PA 19426, USA aut NATIONALLICENCE 700 1- Lelouer V. Rhône D. P. C. Europe 20 Av R. Aron, 92165, Antony Cedex, France aut NATIONALLICENCE 700 1- Vercken Jean-Baptiste Rhône D. P. C. Europe 20 Av R. Aron, 92165, Antony Cedex, France aut NATIONALLICENCE 700 1- Caillon R. Rhône D. P. C. Europe 20 Av R. Aron, 92165, Antony Cedex, France aut NATIONALLICENCE 773 0- Journal of Antimicrobial Chemotherapy Oxford University Press 37(1996-05), 65-72 0305-7453 37<65 1996 37 jac Metadata rights reserved CC BY-NC-4.0 http://creativecommons.org/licenses/by-nc/4.0 nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-oxford