Research Integrity in Pharmacologic Clinical Trials

药理学临床试验中的研究完整性

• 批准号: 6895322
• 负责人: WILLIAM GARDNER
• 金额: $ 3.79万
• 依托单位: RESEARCH INST NATIONWIDE CHILDREN'S HOSP
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-15 至 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6895322
• 关键词: clinical trials; data collection methodology /evaluation; drug screening /evaluation; field study; human subject; human therapy evaluation; interview; longitudinal human study; method development; outcomes research; patient oriented research; questionnaires

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.

研究诚信在临床试验研究中至关重要，因为关于医学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，很少有系统的调查研究诚信的临床试验。鉴于研究诚信通常被视为一种二分法（存在或不存在不当行为），我们提出了一个多层次的定义，该定义承认研究诚信中存在不属于不当行为水平的问题。拟议的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多层次研究的完整性。通过焦点小组和对试验人员的访谈，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诚信问题。完成问卷后，我们将把问卷和研究者的利益冲突量表寄给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，我们将检查研究诚信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有关的发现，将为研究结果与利益冲突有关这一令人不安的观察提供可能的解释。