[Recommendation for studies of optimizing therapy protocols]

Guidelines to establish the principles for the standard of Good Clinical Practice (GCP) for trials on medicinal products in human beings were coming into operation in the European Community in 1991. These recommendations are more extensive than those of the German drug regulatory act (AMG). Included are outlines for the protection of the patient, the responsibilities of the investigator, for biometrics and the quality assurance. Although most of the studies in pediatric oncology optimizing treatment schedules do not belong to the studies as defined by the AMG, certain rules and regulations are strictly adhered to, e.g. the Declaration of Helsinki for the protection of human rights, medical justification of involved risks, adequate and freely obtained informed consent of the patient and the parents. Furthermore, the approval of Ethics Committees must be requested.