Authorship and Conflicts of Interest in Clinical Trails

临床试验中的作者身份和利益冲突

• 批准号: 6829333
• 负责人: WILLIAM GARDNER
• 金额: $ 27万
• 依托单位: RESEARCH INST NATIONWIDE CHILDREN'S HOSP
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-01 至 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6829333
• 关键词: behavioral /social science research tag; bias; clinical research; clinical trials; data collection methodology /evaluation; data management; data quality /integrity; drug design /synthesis /production; ethics; experimental designs; health science profession; health science research; human subject; interview; journals; literature survey; publications

One of the most important issues encountered in research ethics is that of ethical problems in the authorship of clinical trials research. Clinical trials are the principal source of evidence on the efficacy and safety of medical treatments, and they have great financial consequences for manufacturers. Therefore, it is essential that the results of clinical trials be collected and presented in an objective, reliable, and unbiased way. We propose to conduct three surveys of authors of clinical trials. These surveys will examine the relationship between financial conflicts of interest between authors and corporate sponsors of clinical trials and ethical issues concerning the authorship of the paper. We hypothesize that authors who have financial relationships with the manufacturer of the drug or device will have an authorship situation characterized by less control of the trial and its presentation, and less involvement in the writing. The results of this research will provide important data for discussions of editorial policies at scientific journals, for ethical standards and conflict of interest policies at universities and research institutions, and for ethics education in scientific training.

研究伦理学中遇到的最重要的问题之一是临床试验研究作者的伦理问题。临床试验是医学治疗有效性和安全性的主要证据来源，对制造商有很大的经济影响。因此，临床试验的结果必须以客观、可靠和公正的方式收集和呈现。 我们建议对临床试验的作者进行三次调查。这些调查将研究作者和临床试验赞助商之间的经济利益冲突与论文作者身份相关的伦理问题之间的关系。我们假设，与药物或器械制造商有财务关系的作者将具有作者身份，其特征是对试验及其演示的控制较少，并且较少参与写作。本研究的结果将为讨论科技期刊的编辑政策、伦理标准和 在大学和研究机构中实施有关政策以及在科学培训中进行道德教育。