Sollo Natalie, Ahlers-Schmidt Carolyn R, Davis Ann M, Smith Timothy Ryan, Dedeaux Julian A, McCulloh Russell J
Department of Pediatrics, University of Kansas School of Medicine-Wichita, Wichita, KS.
Center for Children's Healthy Lifestyles & Nutrition, University of Kansas Medical Center, Kansas City, KS.
Kans J Med. 2022 Apr 29;15(1):139-143. doi: 10.17161/kjm.vol15.16220. eCollection 2022.
Pediatric clinical trials are difficult to conduct, leading to off-label use of medication in children based on results of trials with adults. As a unique population, children deserve to have appropriately tested therapies. The purpose of this study was to evaluate pediatric caregivers' beliefs and perceived barriers to participation in clinical trials.
The study was completed within the Sunflower Pediatric Clinical Trials Research Extension (SPeCTRE), an affiliate of the IDeA States Pediatric Clinical Trials Network (ISPCTN). This was a cross-sectional survey, adapted from the Pediatric Research Participation Questionnaire. A convenience sample of pediatric caregivers was recruited in three areas of a highly rural Midwestern state between 2017 and 2018.
A total of 159 caregivers completed surveys; the majority (72.3%) were previously familiar with clinical trials, but less than 20% had ever been invited to participate. Caregivers were willing to consider enrolling their child if a physician in whom they had high trust recommended the trials (H = 10.1, p = 0.04) and if there were perceived benefits, such as access to tests and medications not covered by insurance (correlation coefficient [CC] = 0.4, p < 0.01) and compensation for time and travel (CC = 0.3, p = 0.04).
Trust in their physician highly influences likelihood of a caregiver consenting to have their child participate in a clinical trial. Therefore, to facilitate opportunities for children to participate in clinical trials, physicians need to be trained so they can offer trials locally. In addition, trials need to offer benefits, such as increased access to tests and medications as well as appropriate compensation.
儿科临床试验难以开展，导致基于成人试验结果的药物在儿童中的标签外使用。作为一个独特的群体，儿童理应拥有经过适当测试的治疗方法。本研究的目的是评估儿科护理人员对于参与临床试验的信念和感知到的障碍。
该研究在向日葵儿科临床试验研究扩展项目（SPeCTRE）内完成，SPeCTRE是美国综合医学科学推进州际儿科临床试验网络（ISPCTN）的附属机构。这是一项横断面调查，改编自儿科研究参与问卷。2017年至2018年期间，在中西部一个高度农村化的州的三个地区招募了儿科护理人员的便利样本。
共有159名护理人员完成了调查；大多数（72.3%）之前熟悉临床试验，但不到20%曾被邀请参与。如果他们高度信任的医生推荐试验（H = 10.1，p = 0.04），并且如果存在感知到的益处，例如能够获得保险未涵盖的检查和药物（相关系数[CC] = 0.4，p < 0.01）以及时间和交通补偿（CC = 0.3，p = 0.04），护理人员愿意考虑让他们的孩子参加试验。
对医生的信任极大地影响护理人员同意其孩子参与临床试验的可能性。因此，为了促进儿童参与临床试验的机会，医生需要接受培训，以便他们能够在当地提供试验。此外，试验需要提供益处，例如增加获得检查和药物的机会以及适当的补偿。
