Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.
Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.
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DOI：
10.1016/j.conctc.2017.11.005
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发表时间：
2018-03
影响因子：
1.5
通讯作者：
Benjamin DK Jr
中科院分区：
文献类型：
--
作者：
Greenberg RG;Gamel B;Bloom D;Bradley J;Jafri HS;Hinton D;Nambiar S;Wheeler C;Tiernan R;Smith PB;Roberts J;Benjamin DK Jr
儿科临床试验的儿童入组仍然具有挑战性。需要采取更有效的战略，改善招募儿童参加审判的情况。本研究采用了深入的定性访谈与父母谁接触，招募他们的孩子在临床试验，以了解儿科临床试验参与的障碍。对24名有机会参加临床试验的儿童的父母进行了采访：19名儿童参加了至少1项临床试验，5名儿童拒绝参加任何试验。每个研究方面，从研究的最初解释到研究结束，都可能影响父母同意拟议研究和未来研究的意愿。建立信任、适当的时机、面向外行的透明的风险和利益讨论，以及激励儿童参与，是影响父母决定的关键因素。为了使临床试验获得成功，从最初的试验设计开始，父母的优先事项和考虑因素必须成为中心焦点。参与本研究的家长的建议可用于支持预算分配，以确保研究人员得到充分培训，并改善夜间和周末的工作人员配备。在门诊设置和额外的住院设置的父母的反应的研究将提供有价值的信息，从儿童和父母的角度来看，同意过程。需要进一步的研究来探讨这些策略的实施是否会改善儿科临床试验的招募。
Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.