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Noninferiority Trials (noninferiority + trials)

Distribution by Scientific Domains
Medical Sciences40%

Selected Abstracts

Therapeutic Equivalence , Clinical Issues and Statistical Methodology in Noninferiority Trials

BIOMETRICAL JOURNAL, Issue 1 2005
Axel Munk
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 Düsseldorf, 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 Röhmel for his contribution to this special issue. Joachim Röhmel 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 Röhmel'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) [source]

The pros and cons of noninferiority trials

FUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 4 2003
Stuart J. Pocock
Abstract Noninferiority trials comparing new treatment with an active standard control are becoming increasingly common. This article discusses relevant issues regarding their need, design, analysis and interpretation: the appropriate choice of control group, types of noninferiority trial, ethical considerations, sample size determination and potential pitfalls to consider. [source]

Statistical issues in interpreting clinical trials

JOURNAL OF INTERNAL MEDICINE, Issue 5 2004
D. L. DeMets
Abstract. Randomized clinical trial is an important research tool in evaluating new therapeutic agents, devices and procedures. In order to obtain reliable and unbiased results, careful consideration must be given in the design and conduct of the trial. However, bias can be introduced in the analysis of the final data if certain principles are not followed. Several issues are described that make interpretation of analyses challenging. These include the intent-to-treat principle, the use of surrogate outcome measures, subgroup analyses, missing data and noninferiority trials. [source]

Therapeutic Equivalence , Clinical Issues and Statistical Methodology in Noninferiority Trials

BIOMETRICAL JOURNAL, Issue 1 2005
Axel Munk
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 Düsseldorf, 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 Röhmel for his contribution to this special issue. Joachim Röhmel 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 Röhmel'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) [source]