[Testing of drugs in humans. Current responsibilities and problems]

Despite the large number of drugs available, the development of new substances is necessary in view of the unsolved therapeutic problems, for example AIDS, cancer, rheumatoid diseases and disorders of the central nervous system such as Alzheimer's disease. More than ever before, the highest demands have to be made on the efficacy and safety of a new drug. The prerequisites for starting clinical trials in man, and the course of the phases of clinical development are described. Biometry has helped to improve the quality and thus the usefulness of clinical studies. Only in this way has it become possible to establish the superiority of one treatment over another on the basis of objective facts. The results of biometrically planned high-standard studies provide the basis for efficient and ethically justified drug development. They thus also have a direct impact on the fate of the patient.