Department of Haematology, Cardiff University School of Medicine, Cardiff, UK.
Br J Haematol. 2012 Sep;158(6):691-9. doi: 10.1111/j.1365-2141.2012.09213.x. Epub 2012 Jul 5.
It is now 75 years since the publication of Sir Austin Bradford Hill's classic textbook on Medical Statistics, and half a century since the formation of the Medical Research Council Working Party on Leukaemia. In the intervening period, trials in haematological malignancies have been at the forefront of cancer research, both in the proportion of patients recruited, and in the adoption of novel trial designs. In this paper, the principles propounded by Hill for reliable evaluation of new treatments are considered and placed in the context of the development and evaluation of novel treatments in the 21st century. Many of the original principles espoused are still highly relevant today, while the emerging heterogeneity of the conditions, both in aetiology and outcome provide their own newer challenges, which are discussed here.
自奥斯汀·布拉德福德·希尔爵士经典医学统计学教科书出版至今已 75 年,而英国医学研究理事会白血病工作组成立至今也已半个世纪。在此期间,血液系统恶性肿瘤的临床试验一直处于癌症研究的前沿,无论是在招募的患者比例方面,还是在采用新的试验设计方面均是如此。本文考虑了希尔提出的用于可靠评估新疗法的原则,并将其置于 21 世纪新型疗法的开发和评估的背景下。今天,许多最初的原则仍然具有高度相关性,而病因和预后方面的条件异质性也带来了更新的挑战,本文对此进行了讨论。