References

Anderson BJ, Allegaert K, Holford NHG. Population clinical pharmacology of children: general principles. Eur J Pediatr.. 2006; 165:(11)741-746 https://doi.org/10.1007/s00431-006-0188-y

Barned C, Dobson J, Stintzi A, Mack D, O'Doherty KC. Children's perspectives on the benefits and burdens of research participation. AJOB Empir Bioeth.. 2018; 9:(1)19-28 https://doi.org/10.1080/23294515.2018.1430709

Cain MA, McGuinness C. Patient recruitment in paediatric clinical trials. Practical Diabetes International. 2005; 22:(9)328-332 https://doi.org/10.1002/pdi.864

Ethical guidelines for biomedical research involving human subjects.Geneva: Council for International Organizations of Medical Sciences; 2002

Corny J, Bailey B, Lebel D, Bussières JF. Unlicensed and off-label drug use in paediatrics in a mother-child tertiary care hospital. Paediatric Child Health. 2016; 21:(2)83-87 https://doi.org/10.1093/pch/21.2.83

Crane S, Bachus L, Stockman B, Carpenter JS, Lin L, Haase J. Understanding treatment burden and quality of life impact of participating in an early-phase pediatric oncology clinical trial: a pilot study. Journal of Pediatric Oncology Nursing. 2018; 35:(1)25-35

Czarniak P, Bint L, Favié L, Parsons R, Hughes J, Sunderland B. Clinical setting influences off-label and unlicensed prescribing in a paediatric teaching hospital. PLoS One. 2015; 10:(3) https://doi.org/10.1371/journal.pone.0120630

Franson T, Kinnett K, Cripe TP. Unique burdens of pediatric clinical trials in Duchenne muscular dystrophy, April 20-21, 2017, Bethesda, Maryland, USA. Ther Innov Regul Sci.. 2019; 53:(1)154-163 https://doi.org/10.1177/2168479018764650

Friedman DB, Kim SH, Tanner A, Bergeron CD, Foster C., General K. How are we communicating about clinical trials? An assessment of the content and readability of recruitment resources. Contemp Clin Trials. 2014; 38:(2)275-283 https://doi.org/10.1016/j.cct.2014.05.004

Ginsberg G, Hattis D, Sonawane B Evaluation of child/adult pharmacokinetic differences from a database derived from the therapeutic drug literature. Toxicol Sci.. 2002; 66:(2)185-200 https://doi.org/10.1093/toxsci/66.2.185

Grady C, Wiener L, Abdoler E Assent in research: the voices of adolescents. J Adolesc Health. 2014; 54:(5)515-520 https://doi.org/10.1016/j.jadohealth.2014.02.005

Hein IM, Troost P W, de Vries MC, Knibbe CAJ, van Goudoever JB, Lindauer RJL. Why do children decide not to participate in clinical research: a quantitative and qualitative study. Paediatr Res.. 2015; 78:(1)103-108 https://doi.org/10.1038/pr.2015.74

Health Research Authority. Consent and participant information guidance. 2019. https://tinyurl.com/nuqfxpf (accessed 19 November 2019)

Hunfeld JAM, Passchier J. Participation in medical research; a systematic review of the understanding and experience of children and adolescents. Patient Educ Couns.. 2012; 87:(3)268-276 https://doi.org/10.1016/j.pec.2011.09.006

Joret-Descout P, Prot-Labarthe S, Brion F, Bataille J, Hartmann JF, Bourdon O. Off-label and unlicensed utilisation of medicines in a French paediatric hospital. Int J Clin Pharm.. 2015; 37:(6)1222-1227 https://doi.org/10.1007/s11096-015-0191-3

Joseph PD, Craig JC, Caldwell PHY. Clinical trials in children. Br J Clin Pharmacol.. 2015; 79:(3)357-369 https://doi.org/10.1111/bcp.12305

Khdour MR, Hallak HO, Alayasa KSA, AlShahed QN, Hawwa AF, McElnay JC. Extent and nature of unlicensed and off-label medicine use in hospitalised children in Palestine. Int J Clin Pharm.. 2011; 33:(4)650-655 https://doi.org/10.1007/s11096-011-9520-3

Lepola P, Needham A, Mendum J, Sallabank P, Neubauer D, de Wildt S. Informed consent for paediatric clinical trials in Europe: Table 1. Arch Dis Child. 2016; 101:(11)1017-1025 https://doi.org/10.1136/archdischild-2015-310001

Levine DR, Johnson L-z, Madrell BN Does phase 1 trial enrollment preclude quality end of life care? Phase 1 trial enrollment and end of life characteristics in children with cancer. Cancer. 2015; 121:(9)1508-1512 https://doi.org/10.1002/cncr.29230

Madden L, Shilling V, Woolfall K Questioning assent: how are children's views included as families make decisions about clinical trials?. Child Care Health Dev.. 2016; 42:(6)900-908 https://doi.org/10.1111/cch.12347

McLay JS, Tanaka M, Ekins-Daukes S, Helms PJ. A prospective questionnaire assessment of attitudes and experiences of off label prescribing among hospital based paediatricians. Arch Dis Child.. 2006; 91:(7)584-587 https://doi.org/10.1136/adc.2005.081828

Medical Research Council. MRC ethics guide: medical research involving children. 2004. https://tinyurl.com/uye8y5r (accessed 12 November 2019)

Moore S. A need to try everything: patient participation in phase 1 clinical trials. J Adv Nurs.. 2001; 33:(6)738-747 https://doi.org/10.1046/j.1365-2648.2001.01715.x

Moreira H, Carona C, Silva N, Frontini R, Bullinger M, Canavarro MC. Psychological and quality of life outcomes in pediatric populations: a parent-child perspective. J Paediatr.. 2013; 163:(5)1471-1478 https://doi.org/10.1016/j.jpeds.2013.06.028

Naka F, Strober B, Shahriari M. Clinical trials: kids are not just little people. 2017; 35:(6)583-593 https://doi.org/10.1016/j.clindermatol.2017.08.008

National Institutes of Health. NIH clinical research trials and you. Glossary of common terms. 2016. https://tinyurl.com/y8jmgwx2 (accessed 12 November 2019)

Oberman M, Frader J. Dying children and medical research: access to clinical trials as benefit and burden. American Journal of Law and Medicine. 2003; 29:(2-3)301-317

Pagano-Therrien J, Sullivan-Bolyai S. Research participation decision-making among youth and parents of youth with chronic health conditions. J Pediatr Health Care. 2017; 31:(2)167-177 https://doi.org/10.1016/j.pedhc.2016.07.002

Pinto D, Martin D, Chenhall R. Chasing cures: rewards and risks for rare disease patient organisations involved in research. Biosocieties. 2018; 13:(1)123-147 https://doi.org/10.1057/s41292-017-0061-4

Rao R, Sagar R, Kabra SK, Lodha R. Psychiatric morbidity in HIV-infected children. AIDS Care. 2007; 19:(6)828-833 https://doi.org/10.1080/09540120601133659

Informed consent in health and social care research: RCN guidance for nurses, 2nd edn. London: RCN; 2011

Ribeiro M, Jorge A, Macedo AF. Off-label drug prescribing in a Portuguese paediatric emergency unit. Int J Clin Pharm.. 2013; 35:(1)30-36 https://doi.org/10.1007/s11096-012-9699-y

Sammons H, Starkey E. Ethical issues of clinical trials in children. Paediatr Child Health. 2016; 26:(3)95-98 https://doi.org/10.1016/j.paed.2015.09.003

Slažneva J, Kovács L, Kuželová M. Off-label drug use among hospitalized children: identifying extent and nature. Acta Fac Pharm Univ Comen.. 2012; 59:(1)48-54 https://doi.org/10.2478/v10219-012-0016-6

Staphorst MS, Hunfeld JAM, Van de Vathorst S Children's self-reported discomforts and participants in clinical research. Soc Sci Med.. 2015; 142:154-162 https://doi.org/10.1016/j.socscimed.2015.08.019

Tromp K, van de Vathorst S. Parents' perspectives on decisions to participate in pediatric clinical research: results from a focus group study with laypeople. Journal of Empirical Research on Human Research Ethics. 2019; 14:(3)243-253 https://doi.org/10.1177/1556264619845599

Van Hoof W, Meesters K, Dossche L, Christiaens D, De Bruyne P, Vande Walle J. Ethical considerations of researchers conducting pediatric clinical drug trials: a qualitative survey in two Belgian university children's hospitals. Eur J Pediatr.. 2018; 177:(7)1003-1008 https://doi.org/10.1007/s00431-018-3151-9

Woods S, Hagger LE, McCormack P. Therapeutic misconception: hope, trust and misconception in paediatric research. Health Care Anal.. 2014; 22:(1)3-21 https://doi.org/10.1007/s10728-012-0201-8

World Health Organization. Handbook for good clinical research practice. 2002. https://tinyurl.com/vjpz8xh (accessed 19 November 20-19)

Zvonareva O, Kutishenko N, Kulikov E, Martsevich S. Risks and benefits of trial participation: a qualitative study of participants' perspectives in Russia. Clinical Trials. 2015; 12:(6)646-653 https://doi.org/10.1177/1740774515589592

Clinical trials involving children and young people

28 November 2019
Clinical
02 November 2019
Volume 28 · Issue 21

There has been a growing consensus that it is now important to protect children and young people by facilitating their participation in clinical trials rather than ‘protecting them from’ participation. Undoubtedly the inclusion of children and young people in clinical trials is ethically complex and has additional requirements to that of adult trials; however, establishing further medications and treatments that are safe and efficacious is essential.

It is widely recognised that due to developmental and physiological differences (Joseph et al, 2015; Naka et al, 2017) children and young people's participation in clinical trials is integral to the development of new medications that are both safe and efficacious (Cain and McGuinness, 2005; Hunfeld and Passchier, 2012; Staphorst et al, 2015). There is a balance to be achieved between ensuring the paediatric participant is not harmed during individual clinical trial participation and ensuring that the paediatric population is not harmed due to insufficient evidence for prescribing (Sammons and Starkey, 2016). This is particularly pertinent for children and young people with chronic conditions, with increased survival rates facilitated by modern medicine meaning they are living into adulthood, often without prospect of curative treatment (Rao et al, 2007; Moreira et al, 2013). Therefore, further research potentially offering improved care, treatment and quality of life is required (Pagano-Therrien and Sullivan-Bolyai, 2017).

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