78. Pinxten W. et al. Regulating trust in pediatric clinical trials Medicine, Health Care and Philosophy (2008); 11(4), pages 439-444.
Download at: http://www.ncbi.nlm.nih.gov/pubmed/18636344
Aim
This article analyzes how the enrolment of minors in clinical trials is negotiated within relationships of mutual trust between clinicians, minors, and their parents.
Results
There are at least 3 reason why research in children is difficult:
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The limited level of maturity of children generates ethical and legal issues.
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Small number of patients makes research less commercially interesting
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Clinical trials with children are practically difficult, because there is a limited pool of children
Parents and children must be aware of the reasons why they participate in research, what the burdens of participating will be and they must be aware that they have decisional freedom. For this a good level of information needs to be provided to both parents and children. The informed consent is too much focussed on the documentary evidence of consent and assent. It is better to form an ongoing relationship of trust. However there is a potential for bias and not all physicians are capable of forming this relationship. Therefore the authors argue that the best way forward is to empower parents and children. This should be done trough the appointment of an independent counsellor, who informs them and listens to them. The counsellor must have sufficient expertise to assess the information provided to minors and their parents and to examine whether their concerns have been adequately addressed.
79. Hall J.M. et al. Team Research Using Qualitative Methods: Investigating Children’s Involvement in Clinical Research, Journal of Family Nursing (2001); 7, pages 7-31.
Download at: http://jfn.sagepub.com/cgi/content/abstract/7/1/7
Aim
The purpose of this article is to describe the methods and process of a family-focused qualitative study of the clinical research experiences of ill children and their mothers, fathers, and siblings.
80. Caldwell P.H. et al. Clinical trials in children, the Lancet (2004), 364(9436): pages 803-811.
Download at: http://www.ncbi.nlm.nih.gov/pubmed/15337409
Background
Unfortunately, many prescribed treatments for children have not been adequately tested in children. This is however changing. Trials in children are more challenging than those in adults. The pool of eligible children entering trials is often small because many conditions are uncommon in children, and the threshold for gaining consent is often higher and more complex because parents have to make decisions about trial participation on behalf of their child.
Strategies improving clinical trials in children
Authors propose that better education of the medical community and the public is needed about the rationale and risks/benefits. Negatively biased media coverage about clinical trials involving children needs to be balanced with positive public-awareness campaigns about the societal benefits of clinical trial research. Furthermore, researchers must build better relationships with paediatricians and parents by communicating more clearly and openly. Finally they propose that independent ethics committees should become centralised.
81. Broome M.E. et al. Children in Research: The Experience of Ill Children and Adolescents, Journal of Family Nursing, (2001) Vol. 7, No. 1, pages 32-49.
Download at: http://jfn.sagepub.com/cgi/content/abstract/7/1/32
Aim
Children and adolescents are a vulnerable group for clinical trial research. The purpose of this study was to describe the experiences with clinical research of children and adolescents who were diagnosed with either cancer or diabetes.
Results
The perceptions of the children on clinical research varied widely. This was based on age but also on other factors. Children younger than 10 could mostly not identify the risks of participating, but could see overall goals. Some children had difficulties separating research from treatment. Most children had a good understanding of their disease. Due to the severity of the disease; cancer patients were often uninvolved in the informed consent process and often did not recall being asked to participate. Because children with cancer are confronted with dying sooner than diabetes patients they make decisions on the basis of wanting to live. The reasons for participating of diabetes patients were money.
82. Tait A.R. et al. Participation of children in clinical research: factors that influence a parent's decision to consent. Anesthesiology (2003), 99(4): pages 819-825.
Download at: http://www.ncbi.nlm.nih.gov/pubmed/1450831
Aim
This study was designed to identify factors that influence parents' decisions to consent to their child's participation in clinical research.
Findings
Consenters exhibited less uncertainty in their decision making, were more trusting of the medical system, had greater understanding of the research, and believed that the environment in which consent was sought was less pressured than nonconsenters. Predictors of consent included low perceived risk, degree to which the parent read the consent document, characteristics of the consent document, parental understanding, perceived importance of the study, and perceived benefits. Identification of factors that influence parents' decisions to allow their child to participate in a clinical research study will be important by way of developing strategies to improve the manner in which study information is disclosed and to ensure that parents are truly informed.
83. Clinical trials in children, for children, the Lancet (2006); Vol 367, page 1953
Download at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(06)68854¬5/fulltext
Abstract
Health care decisions made for children have relied on research that has been done in adults. This has resulted in a lack of confidence of the public. This lack of confidence will be a hurdle for investigating medicines in children. But there are also a number of good studies; such as those done in cancer. These trials build trust between researchers and families. Trials should however be very carefully designed with special attention to appropriate informed consent and low levels of discomfort for the children involved. The foremost reason for clinical trials in children should be to help future generations.
84. Seyberth H.W. et al. Developing a European framework for research on children’s medicines: an examination of the proposed EU regulation on medicinal products for paediatric use, Pediatric Nephrology (2005) 20: pages 1537–1540.
Download Abstract at: http://www.springerlink.com/content/j1558154769q1261/
Summary
Article on a 2005 conference that examined then yet to be adopted EU Paediatric medicines regulation. Recommendations made were: the creation of properly resourced European networks of paediatric researchers, a focus on ethical issues, such as informed consent, the role of parents, and transparency. Other priorities identified were training for doctors and researchers, better ways of conducting studies in children, and a Paediatric Committee.
85. Sinha I. et al. A systematic review of studies that aim to determine which outcomes to measure in clinical trials in children, PLoS Medicine (2008);5(4):e96.
FREE Download at: http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=18447577
Aim
The aim of this study was to systematically review studies that address the process of selecting outcomes or outcome domains to measure in clinical trials in children. In clinical trials the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another.
Conclusions
Very few studies address the appropriate choice of outcomes for clinical research with children, and in most paediatric specialties no research has been undertaken. Among the studies we did assess, very few involved parents or children in selecting outcomes that should be measured, and none directly involved children. Research should be undertaken to identify the best way to involve parents and children in assessing which outcomes should be measured in clinical trials.
86. Jenny Preston and Dr Nicola Madge. Guidance Notes for Involving Children and Young People in Research -For researchers, research commissioners, and managers
Download Full text at: http://ctuprod.liv.ac.uk/mcrnweb/images/stories/consumer/guidance%20for%20involving% 20children%20in%20research_finaldraft_.pdf
87. Brownlie J, Anderson S, Ormston R. Children as researchers, Scotland, Social Research, Education Dept, Scottish Executive Social Research 2006.
Download full text at: http://www.scotland.gov.uk/Resource/Doc/925/0080040.pdf