Informed consent in pediatric clinical trials

Barfield, Raymond; Church, Christopher

doi:10.1097/01.mop.0000145718.77939.b1

Cited by 60 publications

(45 citation statements)

References 31 publications

(3 reference statements)

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“…[25][26][27][28] Contributing factors to recruitment and retention include lack of trust, inadequate knowledge, fear of side effects and risks, and clinical trial procedures. 25,26,[29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] Although studies have been conducted to understand cultural barriers to participation and retention in clinical trials, none have been conducted in Puerto Rico. [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] In addition, formative research regarding factors related to participation in placebo controlled, vaccine trials is lacking.…”

Section: Introductionmentioning

confidence: 99%

Assessing the interest to participate in a dengue vaccine efficacy trial among residents of Puerto Rico

Guerra

Rodríguez-Acosta

Soto-Gomez

et al. 2012

Human Vaccines & Immunotherapeutics

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Section: Introductionmentioning

confidence: 99%

Assessing the interest to participate in a dengue vaccine efficacy trial among residents of Puerto Rico

Guerra

Rodríguez-Acosta

Soto-Gomez

et al. 2012

Human Vaccines & Immunotherapeutics

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“…No doubt, modifying and measuring informed consent can be difficult, but ways to enhance a process that Wade et al (2009) called a black box [34], by allowing more time for deliberation, by explicitly eliciting and addressing participants' concerns, and by integrating individual patient-based or networks of support, need to be explored. The introduction of interactive computer media to convey complex details between face-toface contact points [35] may a viable and modern strategy to further support such efforts.…”

Section: Resultsmentioning

confidence: 99%

Stem Cell Clinical Trials for Spinal Cord Injury: Readiness, Reluctance, Redefinition

Illes

Reimer

2011

Stem Cell Rev and Rep

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A wealth of scientific and clinical research has focused on the use of stem cells as a potential therapy for spinal cord injury (SCI), culminating most recently in the initiation of clinical trials. However, with the urgency that scientists and clinicians have undertaken to move forward with novel therapies for this devastating injury, the perspectives of stakeholders who live with a SCI have been left behind. Translational research in this rapidly growing field therefore overlooks a critically important viewpoint. We address this concern with a qualitative study of the perspectives on experimental stem cell treatments from individuals who have actually suffered a spinal cord injury. Using focus groups and interviews, we engaged individuals with thoracic and cervical SCIs at sub-acute and chronic stages post-injury. We found four major themes that inform the progression of stem cell research to clinical trials: 'readiness', 'the here and now', 'wait and see', and 'informed hope'. Taken together, the data suggest a profound difference related to target timing of stem cell clinical trials and the perspectives about timing from those who are the end-beneficiaries of therapy. To bridge this gap, we conclude with a number of considerations for the timing disparity of trials and recommendations for improving informed consent.

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“…Providing accessible and understandable information is an essential part of achieving an informed consent and ongoing efforts should continue to ensure the informed consent process and consent documents provide clarity relating to research trial processes for the lay population [32,38,39] . In this study we identified that parents wanted more information regarding standard treatment compared to treatment on a clinical trial.…”

Section: Discussionmentioning

confidence: 99%

Parental perceptions of the informed consent process in pediatric oncology clinical trials

Hastings

Bradford

Lockwood

et al. 2013

JNEP

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Background: The integrity of good clinical practice in clinical trials is underpinned by the informed consent process; however the stress of a life threatening diagnosis challenges the absorption of information and may affect the parent's ability to understand diagnosis, treatment plans and the consent process. Aims:The aim of this study was to explore and describe parental perceptions of the informed consent process in pediatric oncology clinical trials. Methods:A cross-sectional survey was used to collect responses from 50 parents of children aged 8-16 years, enrolled on a clinical trial, one month after diagnosis at an Australian tertiary pediatric oncology centre. Results:The majority of parents (47, 94%) agreed that they understood the diagnosis and information regarding the purpose of the clinical trial. Parents relied primarily on their Oncology consultant for this information. Parents discussed the diagnosis with their children although only 60% (n=30) felt that their child understood the treatment and trial process. Conclusions:Parents indicated that the current process of providing information regarding the clinical trial process met their needs and that they were able to provide informed consent. They were unsure however, of how involved they wanted their children to be in treatment decisions.

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Informed consent in pediatric clinical trials

Cited by 60 publications

References 31 publications

Assessing the interest to participate in a dengue vaccine efficacy trial among residents of Puerto Rico

Assessing the interest to participate in a dengue vaccine efficacy trial among residents of Puerto Rico

Stem Cell Clinical Trials for Spinal Cord Injury: Readiness, Reluctance, Redefinition

Parental perceptions of the informed consent process in pediatric oncology clinical trials

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