Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK.
Trials Research and Methodologies Unit, HRB Clinical Research Facility, University College Cork, Cork, Ireland.
Trials. 2022 Jun 2;23(1):458. doi: 10.1186/s13063-022-06415-5.
At the 2015 REWARD/EQUATOR conference on research waste, the late Doug Altman revealed that his only regret about his 1994 BMJ paper 'The scandal of poor medical research' was that he used the word 'poor' rather than 'bad'. But how much research is bad? And what would improve things?
We focus on randomised trials and look at scale, participants and cost. We randomly selected up to two quantitative intervention reviews published by all clinical Cochrane Review Groups between May 2020 and April 2021. Data including the risk of bias, number of participants, intervention type and country were extracted for all trials included in selected reviews. High risk of bias trials was classed as bad. The cost of high risk of bias trials was estimated using published estimates of trial cost per participant. We identified 96 reviews authored by 546 reviewers from 49 clinical Cochrane Review Groups that included 1659 trials done in 84 countries. Of the 1640 trials providing risk of bias information, 1013 (62%) were high risk of bias (bad), 494 (30%) unclear and 133 (8%) low risk of bias. Bad trials were spread across all clinical areas and all countries. Well over 220,000 participants (or 56% of all participants) were in bad trials. The low estimate of the cost of bad trials was £726 million; our high estimate was over £8 billion. We have five recommendations: trials should be neither funded (1) nor given ethical approval (2) unless they have a statistician and methodologist; trialists should use a risk of bias tool at design (3); more statisticians and methodologists should be trained and supported (4); there should be more funding into applied methodology research and infrastructure (5).
Most randomised trials are bad and most trial participants will be in one. The research community has tolerated this for decades. This has to stop: we need to put rigour and methodology where it belongs - at the centre of our science.
在 2015 年的 REWARD/EQUATOR 会议上，已故的道格·奥特曼（Doug Altman）表示，他对自己 1994 年在《英国医学杂志》（BMJ）上发表的论文《医学研究的丑闻》唯一的遗憾是，他使用了“poor”（差的）这个词，而不是“bad”（坏的）。但是，有多少研究是糟糕的？又有什么可以改善这种情况？
我们专注于随机试验，并研究其规模、参与者和成本。我们随机选择了 2020 年 5 月至 2021 年 4 月期间所有临床 Cochrane 综述组发表的最多两份定量干预性综述。对所选综述中包含的所有试验都提取了偏倚风险、参与者数量、干预类型和国家等数据。高偏倚风险试验被归类为“坏”。使用发表的每名参与者的试验成本估计值来估计高偏倚风险试验的成本。我们从 49 个临床 Cochrane 综述组的 546 位作者中确定了 96 份综述，其中包括 84 个国家开展的 1659 项试验。在提供偏倚风险信息的 1640 项试验中，有 1013 项（62%）为高偏倚风险（坏的），494 项（30%）为不确定，133 项（8%）为低偏倚风险。坏的试验分布在所有临床领域和所有国家。超过 22 万名参与者（或所有参与者的 56%）参与了坏的试验。坏试验成本的低估计值为 7.26 亿英镑；我们的高估计值超过 80 亿英镑。我们有五项建议：（1）除非试验有统计学家和方法学家，否则不应资助或给予其伦理批准；（2）试验设计者应在设计时使用偏倚风险工具；（3）应培训和支持更多的统计学家和方法学家；（4）应投入更多资金用于应用方法学研究和基础设施；（5）。
大多数随机试验都是糟糕的，大多数试验参与者都将参与其中。研究界容忍这种情况已经有几十年了。这种情况必须停止：我们需要将严谨性和方法学放在应有的位置——放在我们科学的中心。
