Berger Vance W, Alperson Sunny Y
National Institutes of Health/National Cancer Institute, 6130 Executive Boulevard, MSC-7354, Bethesda, MD 20892-7354 USA.
Rev Recent Clin Trials. 2009 May;4(2):79-88. doi: 10.2174/157488709788186021.
Flawed evaluation of clinical trial quality allows flawed trials to thrive (get funded, obtain IRB approval, get published, serve as the basis of regulatory approval, and set policy). A reasonable evaluation of clinical trial quality must recognize that any one of a large number of potential biases could by itself completely invalidate the trial results. In addition, clever new ways to distort trial results toward a favored outcome may be devised at any time. Finally, the vested financial and other interests of those conducting the experiments and publishing the reports must cast suspicion on any inadequately reported aspect of clinical trial quality. Putting these ideas together, we see that an adequate evaluation of clinical quality would need to enumerate all known biases, update this list periodically, score the trial with regard to each potential bias on a scale of 0% to 100%, offer partial credit for only that which can be substantiated, and then multiply (not add) the component scores to obtain an overall score between 0% and 100%. We will demonstrate that current evaluations fall well short of these ideals.
对临床试验质量的错误评估会使有缺陷的试验得以盛行（获得资助、获得机构审查委员会批准、发表、作为监管批准的依据并制定政策）。对临床试验质量进行合理评估必须认识到，大量潜在偏差中的任何一个本身都可能使试验结果完全无效。此外，随时可能会设计出巧妙的新方法来将试验结果扭曲为有利的结果。最后，进行实验和发表报告的人员既得的经济利益和其他利益，必然会让人对临床试验质量中任何报告不充分的方面产生怀疑。综合考虑这些因素，我们发现，对临床质量进行充分评估需要列举所有已知偏差，定期更新此列表，针对每个潜在偏差按0%至100%的比例对试验进行评分，仅对能够得到证实的部分给予部分分数，然后将各部分分数相乘（而非相加）以获得0%至100%之间的总分。我们将证明，当前的评估远未达到这些理想标准。
