Meeting the obligation to communicate clinical trial results to study volunteers
Meeting the obligation to communicate clinical trial results to study volunteers
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DOI：
10.1586/ecp.12.7
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发表时间：
2012-03-01
影响因子：
4.4
通讯作者：
Morrison, Briggs
中科院分区：
文献类型：
--
作者：
Getz, Kenneth;Hallinan, Zachary;Morrison, Briggs
尽管绝大多数研究志愿者希望获得有关其参与临床试验结果的信息，但研究表明大多数研究志愿者从未这样做。 CISCRP - 一个独立的非营利组织 - 与辉瑞合作进行了一项研究，评估新流程的可行性和影响，以告知研究志愿者其临床试验的结果。通过调查、焦点小组以及对志愿者和调查现场工作人员的采访对两个过程组成部分进行了评估：一系列正在进行的试验后沟通，以设定何时收到试验结果的期望；以及日常开发和交付非专业语言试验结果摘要。评估结果表明，研究志愿者和研究现场工作人员非常愿意接受临床试验结果，并且准备和传播临床试验结果的过程是可行的并且通常易于执行。结果还表明，研究志愿者对其临床试验测试前和测试后的基本事实的理解提高了 65.6 个百分点，并表明这种沟通举措可能会对志愿者的招募、保留和对临床研究企业的长期信任产生积极影响。
Although the overwhelming majority of study volunteers want to receive information on the results of their participation in clinical trials, research suggests that most study volunteers never do. CISCRP - an independent nonprofit organization - in collaboration with Pfizer, conducted a study evaluating the feasibility and impact of a new process to inform study volunteers of the results of their clinical trials. Two process components were evaluated via surveys, focus groups, and interviews with volunteers and investigative site staff: a series of ongoing post-trial communications to set expectations for when trial results would be received; and routine development and delivery of the lay language trial results summary. The results of this assessment show that study volunteers and investigative site staff are extremely receptive to receiving clinical trial results and that the process of preparing and disseminating clinical trial results is feasible and generally easy to execute. The results also indicate that study volunteer comprehension of basic facts about their clinical trial pre- and post-test increased by as much as 65.6 percentage points, and suggest that this communication initiative may positively impact volunteer recruitment, retention and long-term trust in the clinical research enterprise.