Data management and clinical trials : EORTC Study Group on Data Management

著者

書誌事項

Data management and clinical trials : EORTC Study Group on Data Management

editor, Nicole Rotmensz ; associate editors, Kris Vantongelen, Josette Renard

Elsevier, 1989

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注記

Includes bibliographical references

内容説明・目次

内容説明

There are, at present, some 2000 clinical trials in progress all over the world. For various reasons, however, a good portion of them will not have any impact on oncological practice, mainly because they were poorly designed, inappropriately conducted, improperly analysed, of poor quality or repetitive. There is obviously an acute need for better education in clinical trials among clinicians, so that they will concentate only on significant trials properly conducted, and recruiting a large number of patients. This book presents a sound evaluation of the problems connected with the conduct of clinical trials, with a special emphasis on the need for a strict interaction between clinicians, data managers and statisticians. Most of the crucial problems related to "data management and clinical trials" have been reviewed, and the reader is furnished with an objective picture of a subject which although hostile to many doctors should become familiar to all clinicians who have at heart the duty and desire to combine the progress of science with the safeguard of the cancer patient.

目次

Preface (U. Veronesi). I. General Aspects of Clinical Trials. 1. Introduction (H. Tagnon). 2. Phase I, II and III Trials: Role, description and statistical design (R. Sylvester). 3. Introduction to oncology, biology and treatment of cancer (J.G. McVie). 4. Ethical considerations for clinical trials in cancer patients (R. Zittoun and H. Sancho-Garnier). II. Local Data Management. 1. Data Managers, skills and training (E. Van der Putten and M. C. Boon). 2. Organization of a local clinical trial office (K. Vantongelen). 3. Guidelines for data collection and interpretation of patient charts (M. Kerr and L. Mill). 4. The Management of local trials (H. R. Franklin). III. Multicentric Data Management. 1. The role of a Data Center (M. Van Glabbeke and M. Staquet). 2. Forms: Design and contents (M. De Pauw). 3. Quality control and data handling (J. Renard and M. Van Glabbeke). 4. The role of the study coordinator in cancer clinical trials (P. Dodion and R. Abele). 5. Statistics in clinical trials (R.D. Gelber and A. Goldhirsch). 6. Computer system for multicentric clinical trials (P. Firket). 7. Behind the clinical trial. The Data Managers supportive role (N. Rotmensz). IV. Personal Computers. 1. Personal computer software for clinical trials (J. Herson).

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