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首页> 外文期刊>Therapeutic innovation & regulatory science. >Industry and Patient Perspectives on Child Participation in Clinical Trials: The Pediatric Assent Initiative Survey Report
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Industry and Patient Perspectives on Child Participation in Clinical Trials: The Pediatric Assent Initiative Survey Report

机译：对儿童参与临床试验的行业和患者观点：儿科同意倡议调查报告

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Background: Obtaining assent from children participating in clinical trials acknowledges autonomy and developmental ability to contribute to the consent process. This critical step in pediatric drug development remains poorly understood, with significant room for improving the clarity, efficiency, and implementation of the assent process. Beyond ethical necessity of informing children about their treatment, the assent process provides the advantages of including children in discussions about their diagnosis and treatment-allowing greater understanding of interventions included in the study. A formalized assent process acknowledges the child as a volunteer and provides a forum for questions and feedback. Legal, cultural, and social differences have historically prevented the development of clear, concise, and accessible materials to ensure children understand the clinical trial design. Published guidelines on obtaining pediatric assent are vague, with many decisions left to local institutional review boards and ethics committees, underscoring the need for collaboratively designed standards. To address this need, 2 surveys were conducted to quantify perspectives on assent in pediatric clinical trials. Methods: Two digital surveys were circulated in the United States and internationally (October 2014 to January 2015). The first survey targeted children, parents, and/or caregivers. The second polled clinical trial professionals on their organizations' experience and policies regarding pediatric assent. Results: Forty-five respondents completed the child and parent/caregiver survey; 57 respondents completed the industry survey. Respondents from both surveys detailed experiences with clinical trials and the impediments to securing assent, offering potential solutions to attaining assent in pediatric patients. Conclusions: An important opportunity exists for standardized practices and tools to ensure pediatric patients make well-informed decisions regarding their participation in clinical trials, using materials appropriate to their level of understanding. These tools would establish a baseline standard for the assent process and be made available to researchers, improving their ability to secure assent from young patients.
机译：背景：获得参与临床试验的儿童的同意承认自治和发展能力为同意过程做出贡献。儿科药物开发的这一关键步骤仍然明白，有很高的空间，可提高澄清过程的清晰度，效率和实施。除了告知儿童的道德必需品，有关他们的待遇，同盟过程提供了儿童在讨论其诊断和治疗方面的优势 - 允许更加了解研究中的干预措施。正式化的同意进程承认孩子作为志愿者，并为问题和反馈提供论坛。在历史上，法律，文化和社会差异历史妨碍了明确，简洁和无障碍的材料的发展，以确保儿童了解临床试验设计。已发表的关于获得儿科同意的指导方针是模糊的，许多决定留给当地的机构审查委员会和伦理委员会，强调了对合作设计的标准的需求。为了解决这一需求，进行了2调查，以量化在儿科临床试验中同意的视角。方法：两项数字调查在美国和国际上发行（2014年10月至2015年1月）。第一次调查有针对性的儿童，父母和/或照顾者。第二次民意调查临床试验专业人员对其组织的经验和有关儿科同意的政策。结果：四十五名受访者完成了儿童和家长/看护人调查; 57名受访者完成了行业调查。来自审查的受访者对临床试验的详细经验以及确保同意的障碍，提供潜在的解决方案，以达到儿科患者的同意。结论：标准化实践和工具存在一个重要的机会，以确保儿科患者提供有关其参与临床试验的知情决策，利用适合其理解程度的材料。这些工具将为同意过程建立基线标准，并提供给研究人员，从而提高他们确保患有年轻患者的能力。

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