Manual for the Planning and Implementation of Therapeutic Studies

Manual for the Planning and Implementation of Therapeutic Studies

4.11 - 1251 ratings - Source

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 qFederal Government's Program on Promoting Research and Development in the Service of Healthq. 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~ a€c . 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.when long-term studies are planned, special care must be taken to organize a meaningful follow-up. The expected drop-out ... However, there may be limitations in this regard due to constraints on patient availability, e.g., in studies on rare diseases. 3.4. Termination of ... fixed points in time. We know from experience with controlled clinical studies that the presentation 62 Termination of Therapeutic Studies.

Title:Manual for the Planning and Implementation of Therapeutic Studies
Author:S. Biefang, W. Köpcke, M.A. Schreiber
Publisher:Springer Science & Business Media - 2013-03-13


You Must CONTINUE and create a free account to access unlimited downloads & streaming