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Investigator experiences with financial conflicts of interest in clinical trials

机译:研究者在临床试验中遇到财务利益冲突的经验

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摘要

Abstract Background Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience. Methods Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source. Results 844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials. Conclusion Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.
机译:摘要背景财务利益冲突(fCOI)可能会引入一些偏向临床试验结果并降低其客观性的措施。我们从研究人员那里获得了有关遵守惯例的信息,这些惯例可以最大程度地减少在临床试验中引入这种偏见。方法通过电子邮件对来自加拿大站点的临床试验研究人员进行调查,以了解遵守实践的情况,这些实践有助于在试验准备,实施和传播的所有阶段保持研究独立性。主要结果是,报告按比例列出按2001年至2006年进行的所有试验均完全遵循首选试验方法的研究者的比例。结果844位研究者做出了回应(占76%),而732位研究者(占66%)提供了有用的信息。对于签署的合同和预算进行机构审查,完全遵守首选的临床试验做法是最高的(分别为研究人员的82%和75%)。据报道,其他两种做法在审判准备阶段的完全遵守率较低(避免保密条款,占12%; 2005年以后的审判注册,占39%)。据报道,在试验阶段(35%至43%)和传播阶段(53%至64%),特别是在行业资助的试验中,有7种实践的完全遵守率较低。 269位调查员亲身经历了fCOI(n = 85)或见证了(n = 236)fCOI;这些情况中有70%以上与行业试验有关。结论完全遵守旨在促进研究客观性的实践,在各个试验阶段均存在差异,并且总体上较低,特别是对于行业资助的试验。

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