Manual for the Planning and Implementation of Therapeutic Studies

  • Sibylle Biefang
  • Wolfgang Köpcke
  • Martin A. Schreiber
Conference proceedings

Part of the Lecture Notes in Medical Informatics book series (LNMED, volume 20)

Table of contents

  1. Front Matter
    Pages N2-v
  2. Sibylle Biefang, Wolfgang Köpcke, Martin A. Schreiber
    Pages 1-21
  3. Sibylle Biefang, Wolfgang Köpcke, Martin A. Schreiber
    Pages 22-46
  4. Sibylle Biefang, Wolfgang Köpcke, Martin A. Schreiber
    Pages 47-65
  5. Sibylle Biefang, Wolfgang Köpcke, Martin A. Schreiber
    Pages 66-72
  6. Sibylle Biefang, Wolfgang Köpcke, Martin A. Schreiber
    Pages 73-88
  7. Sibylle Biefang, Wolfgang Köpcke, Martin A. Schreiber
    Pages 89-100
  8. Back Matter
    Pages 103-103

About these proceedings


The German edition of this manual appeared in 1979. Its main objective then was to extend help to those engaged in multiaentric therapeutic studies, especially with respect to the "Federal Government's Program on Promoting Research and Development in the Service of Health". Experience with therapeutic studies in the Federal Republic of Germany showed that considerable problems as to methods and implementation of such studies exist. The manual was an attempt to present current metho­ dological knowledge and the experience obtained from completed studies in the light of the international literature. No radically new methodo­ logy was produced; however, the information representing the state-of­ the art, which is widely scattered up to now, has been compiled. For the American edition of this manual a few changes have been made. These concern especially the literature where references to German un­ published manuscripts were omitted. The authors wish to thank Dr. Andreas Jaffe for the translation, and Evelyn Birke who typewrited the lecture-notes manuscrip~ • . GUnzburg and Munich Sibylle Biefang November 1981 Wolfgang Kopcke Martin A. Schreiber Contents Page Foreword 1. Methods of Therapeutic Studies 2 1. 1. Terminology 4 1. 2. Experimental Design 11 1. 3. Types of Studies 20 1. 4. Steps in Drug Testing 2. Checklist for the Planning, Implementation and Evaluation 22 of Therapeutic Studies 22 2. 1. Planning of Experiments 29 2. 2. Documentation 36 2. 3. Organization 41 2. 4. Statistical Analysis 44 2. 5.


Kontrollierte Therapiestudie assessment development documentation drug evaluation health organizations planning quality quality control research translation

Authors and affiliations

  • Sibylle Biefang
    • 1
  • Wolfgang Köpcke
    • 2
  • Martin A. Schreiber
    • 2
  1. 1.Internationales Institut für wissenschaftliche Zusammenarbeit e.V.GünzburgGermany
  2. 2.Institut für Medizinische Informationsverarbeitung, Statistik und BiomathematikLudwig-Maximilians-UniversitätMünchen 70Germany

Bibliographic information

  • DOI
  • Copyright Information Springer-Verlag Berlin Heidelberg 1983
  • Publisher Name Springer, Berlin, Heidelberg
  • eBook Packages Springer Book Archive
  • Print ISBN 978-3-540-11979-1
  • Online ISBN 978-3-642-93237-3
  • Series Print ISSN 0172-7788
  • Buy this book on publisher's site