Research Integrity in Pharmacologic Clinical Trials

研究的完整性在临床试验研究中至关重要，因为关于药物治疗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，很少有系统的研究在临床试验中的研究完整性。而研究诚信往往被视为二分法（存在或不存在的不当行为），我们提出了一个多层次的定义，认识到有问题的研究诚信，不属于不当行为的水平。 该研究是一个为期两年的项目，旨在开发一种方法来衡量药理学临床试验中的多层次研究完整性。 通过焦点小组和与试验者的访谈，我们将开发一个自填式问卷，询问研究者关于临床试验中的研究诚信问题。 在制定了调查问卷后，我们将把它和研究者利益冲突的衡量标准邮寄给500名已发表临床试验的作者。 我们还将根据已发表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者的经济利益冲突相关。我们提出的问卷调查将提供一个研究诚信的实地研究的工具。 此外，通过研究诚信问题是否与研究成果相关，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，经济利益冲突与违反研究完整性有关的发现将为研究结果与利益冲突有关的令人不安的观察提供可能的解释。

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.