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一、如何进行临床试验研究?首先,试验要提出一个重要的需解决的问题;其次,所得结论应是确实可靠的。怎样才算是一个比较重要的课题呢?譬如,要评估某一治疗方法的治疗效果,如果这个疾病普遍存在,该治疗方法简单易行,观察的终点指标至关重要(如死亡事件,而不是一般生化改变),提出的问题长期无确切答案,那么,这可被认为是一个比较重要的课题。例如,早期乳腺癌病人,手术切除乳腺和可检出的肿块后,局部组织可能仍有少量癌细胞残留,以后可能会继续发展,威胁生命。那么术后是否需要局部常规放射治疗?放射治疗是否能改善预后?这是一个尚待解决的重要问题。1962-1977年十五年间就此问题发表的46篇
First, how to conduct clinical trials? First of all, the trial should be made an important problem to be solved; second, the conclusions should be reliable. For example, to assess the treatment effect of a particular treatment, if the disease is prevalent, the treatment is simple and easy, and the end point of the observation is crucial (eg death, not general Biochemical changes), the long-term questions raised no definite answer, then, this can be considered as a more important issue. For example, early breast cancer patients, surgical removal of the breast and detectable lumps, the local tissue may still have a small amount of residual cancer cells, the future may continue to develop and threaten life. Then whether the need for local conventional radiotherapy after surgery? Radiation therapy can improve the prognosis? This is an important issue yet to be resolved. 46 articles published on this issue during the fifteen-year period 1962-1977