Research Integrity in Pharmacologic Clinical Trials

研究完整性在临床试验研究中至关重要，因为有关药物治疗的安全性和有效性的决策必须基于公正且可靠的证据。 然而，对临床试验中研究完整性的系统调查却很少。尽管研究诚信通常被视为二分法（存在或不存在不当行为），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级别的问题。 拟议的研究是一个为期两年的项目，旨在开发一种衡量药理学临床试验中多层次研究完整性的方法。 通过焦点小组和对试验人员的访谈，我们将制定一份自填问卷，向研究者询问临床试验中的研究诚信问题。 制定完调查问卷后，我们将把调查问卷和调查人员利益冲突的衡量标准邮寄给已发表的临床试验的 500 位作者。 我们还将根据已发表的报告对试验方法的质量进行编码。 利用这些数据，我们将检查研究诚信水平是否与临床试验结果、试验方法的质量以及研究者的经济利益冲突相关。我们提出的调查问卷将为研究诚信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，经济利益冲突与违反研究诚信相关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.