The controlled clinical trial has become an essential part of the clinician's decision-making process. Clinical trials, however, still raise methodological problems that are important and at the same time controversial: subgroup analysis and interactions, meta-analy sis of similar trials, consideration of subjective clinical opinions and those of the public at large, assessment of quality of life, pre vention trials, and so on. In February 1987 we took our third step along the road to evaluating these issues in dialogues between cli nicians, psychologists, legal experts, and statisticians. The talks presented at the meeting were revised by the authors afterwards and have been rearranged by the editors to form a strictly organ 1 2 ized book. The two preceding meetings in 1978 and 1981 focused strongly on adjuvant therapy in primary breast cancer, but this top ic served merely as a nucleus in the third meeting. This meeting, although called the Third Heidelberg Symposium was forced to leave Heidelberg and in fact was held in Freiburg. Without the interest and enthusiasm of Professor Martin Schu macher and his colleagues in Freiburg the meeting would never have taken place. The meeting was generously supported again by the Federal Ministry of Research and Technology (Bundesministe rium flir Forschung und Technologie, BMFT) within the framework of the West German BMFT Breast Cancer Study Group. We are grateful, in particular, to Mr. Hans W. Herzog for his personal in volvement. Juni 1988 H. Scheurlen, R. Kay, M.

Klappentext

The book is devoted to improved communication between clinicians, psychologists, and legal experts on the one hand and methodologists on the other. Mathematical formalism is therefore kept to a minimum and on a level acceptable to all sides. The contributions provide strictly organized coverage of the following topics: scientific fundamentals; heterogeneous treatment effects; combined information in historical controls, overviews, and comprehensive cohort studies; subjective opinions and informed consent; and assessment of quality of life. It is these aspects that are crucial in the planning of clinical trials and in the analysis and interpretation of results. Since there is still much debate between clinicians and statisticians on the subject, this book may prevent the reader from embarking on poorly planned clinical trials.

Inhalt
Scientific Fundamentals.- The Crooked Path Toward the Objectivation of Therapeutic Experience.- Randomised Trials: The Case for Science in Medicine.- A Critical Assessment of Approaches to Improving the Efficiency of Cancer Clinical Trials.- Statistical Standards for Protocols and Protocol Deviations.- The Design of Cancer Prevention Trials.- Heterogeneous Treatment Effects.- Strategies for Subgroup Analysis in Clinical Trials.- Statistical Tools for Subset Analysis in Clinical Trials.- Competing Risks, Interactions and Crossing Hazards.- Significance Testing in the Comparison of Survival Curves from Clinical Trials of Cancer Treatment.- Estimating the Magnitude of Benefits from Adjuvant Therapy.- Treatment by Protocol: Assessment of Gains and Losses.- On Combining Information: Historical Controls, Overviews, and Comprehensive Cohort Studies.- The Use of Data Bases and Historical Controls in Treatment Comparisons.- Limitations and Advantages of Meta-analysis in Clinical Trials.- Overview of Adjuvant Radiotherapy for Breast Cancer.- Overview of Randomized Trials of Postoperative Adjuvant Radiotherapy in Breast Cancer.- Combining Randomized and Nonrandomized Patients in the Statistical Analysis of Clinical Trials.- The Comprehensive Cohort Study: The Use of Registry Data to Confirm and Extend a Randomized Trial.- Subjective Opinions and Informed Consent.- Treatment Decisions in Breast Cancer.- Randomization and Follow-up Care of Patients in a Breast Cancer Clinical Trial: Personal Experience.- Alternative Treatments for Small Cancers of the Breast: Motives and Preferences of Patients Having to Choose.- Subjective Theories on Etiology and Treatment of Cancer.- Individual Cases and the Scientific MethodA Conflict? Legal Aspects of Cancer Clinical Trials in the FederalRepublic of Germany.- The Value of Small Clinical Trials.- A Predictive Approach to Selecting the Size of a Clinical Trial, Based on Subjective Clinical Opinion.- Statistical Properties and Use of Sequential Methods in Randomized Clinical Trials when the Response Criterion Is Censored.- Assessment of Quality of Life.- Measurement of Quality of Life in Clinical Trials of Therapy.- A Modular Approach to Quality-of-Life Assessment in Cancer Clinical Trials.- Effects of Breast Conservation on Psychological Morbidity Associated with Diagnosis and Treatment of Early Breast Cancer.- Evaluation of Psychosocial Aspects in a Breast Preservation Trial.