Conducting a paediatric multi-centre RCT with an industry partner: challenges and lessons learned

Maskell, Jessica, Newcombe, Peter, Martin, Graham and Kimble, Roy (2012) Conducting a paediatric multi-centre RCT with an industry partner: challenges and lessons learned. Journal of Paediatrics and Child Health, 48 11: 974-977. doi:10.1111/j.1440-1754.2012.02510.x


Author Maskell, Jessica
Newcombe, Peter
Martin, Graham
Kimble, Roy
Title Conducting a paediatric multi-centre RCT with an industry partner: challenges and lessons learned
Journal name Journal of Paediatrics and Child Health   Check publisher's open access policy
ISSN 1034-4810
1440-1754
Publication date 2012-11-01
Sub-type Article (original research)
DOI 10.1111/j.1440-1754.2012.02510.x
Volume 48
Issue 11
Start page 974
End page 977
Total pages 4
Place of publication Chichester, West Sussex, United Kingdom
Publisher Wiley-Blackwell
Language eng
Abstract There are many benefits of multi-centred research including large sample sizes, statistical power, timely recruitment and generalisability of results. However, there are numerous considerations when planning and implementing a multi-centred study. This article reviews the challenges and successes of planning and implementing a multi-centred prospective randomised control trial involving an industry partner. The research investigated the impact on psychosocial functioning of a cosmetic camouflage product for children and adolescents with burn scarring. Multi-centred studies commonly have many stakeholders. Within this study, six Australian and New Zealand paediatric burn units as well as an industry partner were involved. The inclusion of an industry partner added complexities as they brought different priorities and expectations to the research. Further, multifaceted ethical and institutional approval processes needed to be negotiated. The challenges, successes, lessons learned and recommendations from this study regarding Australian and New Zealand ethics and research governance approval processes, collaboration with industry partners and the management of differing expectations will be outlined. Recommendations for future multi-centred research with industry partners include provision of regular written reports for the industry partner; continual monitoring and prompt resolution of concerns; basic research practices education for industry partners; minimisation of industry partner contact with participants; clear roles and responsibilities of all stakeholders and utilisation of single ethical review if available.
Keyword Children
Ethics
Industry partners
Multi-centred randomised control trial
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2013 Collection
School of Medicine Publications
School of Nursing, Midwifery and Social Work Publications
 
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