Onkologie. 1985 Apr;8(2):133-6. doi: 10.1159/000215636.
A proposal for the composition of chemotherapeutic phase-II-trials from the Phase-II Study Group of the Study Group for Clinical Oncology of the German Cancer Society is herewith presented. The recent international standard is taken into consideration. The master protocol shows the formal aspects of such a study, refers to the relevant and complete representation of the related literature, emphasizes the clear formulation of the introduction and the aim of the study, presents the patient including and excluding criteria, gives a formal proposal for description of the study drugs, the side effects and supportive therapy, the diagnostic procedures and the response criteria. The problems of patient information, documentation and statistics as well as administrative aspects are mentioned.
德国癌症协会临床肿瘤学研究组的II期研究小组提出了一份关于化疗II期试验组成的提案。其中考虑了近期的国际标准。总体方案展示了此类研究的形式方面，提及了相关文献的全面且恰当的呈现，强调了研究引言和目的的清晰表述，列出了患者纳入和排除标准，给出了关于研究药物、副作用和支持性治疗、诊断程序以及反应标准描述的正式提案。还提到了患者信息、记录和统计以及管理方面的问题。
