Conducting a paediatric multi-centre RCT with an industry partner: Challenges and lessons learned
Article first published online: 14 AUG 2012
© 2012 The Authors. Journal of Paediatrics and Child Health © 2012 Paediatrics and Child Health Division (Royal Australasian College of Physicians)
Journal of Paediatrics and Child Health
Volume 48, Issue 11, pages 974–977, November 2012
How to Cite
Maskell, J., Newcombe, P., Martin, G. and Kimble, R. (2012), Conducting a paediatric multi-centre RCT with an industry partner: Challenges and lessons learned. Journal of Paediatrics and Child Health, 48: 974–977. doi: 10.1111/j.1440-1754.2012.02510.x
- Issue published online: 5 NOV 2012
- Article first published online: 14 AUG 2012
- Accepted for publication 9 September 2011.
- industry partners;
- multi-centred randomised control trial
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.