The Principles and Practice of Clinical Trials [antikvár]

FOREWORD The therapeutic revolution of the past thirty years, with the introduction of so many potent synthetic drugs, has resulted mainly from research in the laboratories of the pharmaceutical industry. Of the stream of compounds that leave the chemist's bench, few survive the long series of rigorous tests for pharmacological activity, for specificity and for animal toxicity to reach the stage of human trial. Those that then appear to be both safe and active as a result of preliminary tests in man must be submitted to the most careful clinical trial before final acceptance by the Committee on Safety of Drugs permits clinical use. The controlled clinical trial of new therapeutic agents is a discipline that has been evolved and has become most highly developed in Great Britain and for which a rigid ethical code now exists. The organisation of such trials demands the closest cooperation between the pharmaceutical industry and the medical profession and the present friendly and effective relationship, based on mutual confidence and understanding, owes much to the work of the medical advisers to the pharmaceutical industry. These medical advisers are experts in the various techniques of controlled trial and in the statistical analysis and interpretation of results. Though not normally directly involved, they have acquired a great knowledge and understanding of the difficulties and problems that face the clinician. As President of the Royal College of Physicians of London I was, therefore, delighted when Dr G. R. Daniel, Chairman of the Association of Medical Advisers in the Pharmaceutical Industry suggested that their association might hold a symposium on the Principles and Practice of Clinical Trials in the College. The present volume includes the many interesting contributions to that symposium—contributions from research workers in industry, from pure pharmacologists and clinical pharmacologists, from clinicians and statisticians—and presents a most fascinating and readable account of clinical trials. Illustrating as it does the close cooperation between academic and industrial scientists, I am confident that this book will receive a warm welcome and will be widely appreciated; I believe that it will contribute to the strengthening of the understanding that now so closely links the pharmaceutical industry and the medical profession. M. L. Rosenheim 1970.