Freedman L S
MRC Cancer Trials Office, Cambridge, UK.
Br J Cancer. 1989 Mar;59(3):396-400. doi: 10.1038/bjc.1989.79.
Most randomised clinical trials of cancer treatment include a few hundred patients or less. Recent statistical papers advocate that sometimes thousands of patients should be entered. In this paper I show that for certain types of cancer trials the 'thousands policy' is not required while for others it is desirable but not feasible. In the latter case other strategies should be considered, such as two-stage phase III studies or parallel studies leading to overviews. There is, however, an important subset of trials for which application of the thousands policy is both necessary and feasible. The key to progress lies partly in the achievement of greater recruitment rates in trails of common cancers and partly in greater inter-group collaboration.
大多数癌症治疗的随机临床试验纳入的患者为几百人或更少。近期的统计学论文主张，有时应该纳入数千名患者。在本文中，我表明对于某些类型的癌症试验，“数千人策略”并非必要，而对于其他类型的试验，该策略虽有必要但不可行。在后一种情况下，应考虑其他策略，比如两阶段III期研究或能得出综述的平行研究。然而，有一类重要的试验子集，对于它们而言，应用数千人策略既必要又可行。取得进展的关键部分在于在常见癌症试验中实现更高的招募率，部分在于加强组间协作。
