Research Integrity in Pharmacologic Clinical Trials

研究的完整性在临床试验研究中是至关重要的，因为关于医疗疗法的安全性和有效性的决定必须基于公正和可信的证据。然而，在临床试验中，很少有对研究完整性的系统调查。尽管研究诚信通常被视为一种二分法(是否存在不当行为)，但我们提出了一个多层次的定义，承认研究诚信中存在不属于不当行为水平的问题。这项拟议的研究是一个为期两年的项目，旨在开发一种在药理学临床试验中衡量多水平研究完整性的方法。利用焦点小组和对试验者的采访，我们将开发一份自我管理的问卷，向研究人员询问临床试验中的研究完整性问题。在制定了调查问卷后，我们将把它和一项衡量研究人员利益冲突的指标邮寄给500名已发表临床试验的作者。我们还将根据公布的报告对试验方法的质量进行编码。使用这些数据，我们将检查研究完整性水平是否与临床试验结果、试验方法的质量和研究人员的经济利益冲突有关。我们提出的问卷将为研究完整性的实地研究提供一个工具。此外，通过检查研究诚信问题是否与研究结果相关，我们将获得有关研究诚信问题的社会成本的重要信息。最后，财务利益冲突与违反研究完整性的发现将为研究结果与利益冲突相关的令人不安的观察提供一个可能的解释。

Research integrity is essential in clinical trials research, because decisions about the safety and efficacy of medical therapies must be based on unbiased and credible evidence. However, there has been little systematic investigation of research integrity in clinical trials. Whereas research integrity is often treated as a dichotomy (presence or absence of misconduct), we propose a multi-level definition that recognizes that there are problems in research integrity that do not fall to the level of misconduct. The proposed research is a two-year project to develop a method to measure multi-level research integrity in pharmacologic clinical trials. Using focus groups and interviews with trialists, we will develop a self-administered questionnaire that asks investigators about research integrity problems in clinical trials. Having developed the questionnaire, we will mail it and a measure of investigators' conflicts of interest to 500 authors of published clinical trials. We will also code the quality of the trials' methods from the published reports. Using these data, we will examine whether levels of research integrity are associated with clinical trial outcomes, quality of trial methods, and investigators' financial conflicts of interest. The questionnaire we propose would provide a tool for field studies of research integrity. Moreover, by examining whether problems of research integrity are associated with study outcomes, we will obtain important information about the social costs of problems in research integrity. Finally, a finding that financial conflicts of interest are associated with violations of research integrity would provide a possible explanation for the troubling observation that study outcomes are associated with conflicts of interest.