Bland J M, Jones D R, Bennett S, Cook D G, Haines A P, MacFarlane A J
Br J Clin Pharmacol. 1985 Feb;19(2):155-60. doi: 10.1111/j.1365-2125.1985.tb02626.x.
The statistical adequacy of all papers published in the period 1976-80 describing clinical trials of five non-steroidal anti-inflammatory and two analgesic drugs introduced into the UK market in 1978 and 1979 has been assessed using a checklist of simple criteria. Most trials were reported to be randomised and double-blind. Trial designs were less satisfactory in other important respects; the sample size of most trials was inadequate to demonstrate superiority of the new drug compared with an active control therapy. The period of treatment assessment was short in view of the likelihood of prolonged prescription of drugs in these classes. It is suggested that licensing authorities should demand higher standards of clinical trial evidence offered in support of new drugs.
使用一份简单标准清单，对1976年至1980年期间发表的、描述1978年和1979年引入英国市场的五种非甾体抗炎药和两种镇痛药临床试验的所有论文的统计学充分性进行了评估。据报道，大多数试验都是随机双盲的。在其他重要方面，试验设计不太令人满意；大多数试验的样本量不足以证明新药相对于活性对照疗法的优越性。鉴于这些药物类别的处方可能会延长，治疗评估期较短。建议许可当局要求提供更高标准的支持新药的临床试验证据。
