A General Framework for the Evaluation of Clinical Trial Quality
A General Framework for the Evaluation of Clinical Trial Quality
复制标题
DOI：
10.2174/157488709788186021
复制
发表时间：
2009-01-01
影响因子：
1.9
通讯作者：
Alperson, Sunny Y.
中科院分区：
文献类型：
--
作者：
Berger, Vance W.;Alperson, Sunny Y.
对临床试验质量的有缺陷的评估允许有缺陷的试验蓬勃发展（获得资助，获得IRB批准，发表，作为监管批准的基础，并制定政策）。对临床试验质量的合理评价必须认识到，大量潜在偏倚中的任何一个本身都可能使试验结果完全无效。此外，任何时候都有可能设计出巧妙的新方法来扭曲试验结果，使其朝着有利的结果发展。最后，那些进行实验和发表报告的人的既得经济利益和其他利益必须对临床试验质量的任何不充分报告方面产生怀疑。将这些想法放在一起，我们看到，对临床质量的充分评价需要列举所有已知的偏倚，定期更新该列表，在0%至100%的范围内对每个潜在偏倚进行评分，仅对可以证实的部分给予部分评分，然后乘以（而不是相加）组分评分以获得0%至100%之间的总分。我们将证明，目前的评估远远达不到这些理想。
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.