Therapeutic equivalence--clinical issues and statistical methodology in noninferiority trials.

This special issue on therapeutic equivalence contains a selection of 8 papers presented at the conference ‘Therapeutic Equivalence – Clinical Issues and Statistical Methodology in Noninferiority Trials’ held in Dusseldorf, December 12–13, 2003. The aim of this conference was to gather experts from academics, industry and regulatory agencies in the field of therapeutic equivalence, in particular of noninferiority trials. Originally initiated as a small workshop, it soon turned out that there is obviously strong need to discuss these challenging issues at a broader auditorium. Indeed, the feedback to this conference was overwhelming, finally more than 300 researchers participated. Hence the idea emerged to collect the results and discussions in a single journal issue. It took more than a year to finish it, and various activities in this rapidly developing area have been going on and were incorporated. We are very grateful to the Editors E. Brunner and M. Schumacher of the Biometrical Journal for their encouragement and support to publish this special issue on the occasion of this conference. Further, the technical assistance and expertise of G. Skipka and K. Thangavelu is gratefully acknowledged. We are also indebted to Peter Bauer and Stephen Senn for their discussions of the subsequent articles by Bristol, Freitag, Hauschke, Slacik-Erben, Hensen and Kaufmann, Hung, Wang and O'Neill, Lange and Freitag, Tsong and Zhang, Wellek, and last but not least we would like to thank Joachim Rohmel for his contribution to this special issue. Joachim Rohmel contributed significantly during the last three decades to various branches of biostatistical research, and in particular to the design and analysis of equivalence trials. The aim of this special issue is therefore twofold, it is also devoted to the occasion of Joachim Rohmel's retirement from BfArM in 2004. In the following we would briefly like to express our deep appreciation of his scientific work. (© 2005 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim)