Conducting a paediatric multi-centre RCT with an industry partner: challenges and lessons learned.
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.
Department of Paediatrics and Child Health, The University of Queensland, Brisbane, Australia. jessica.jameschadwick@uqconnect.edu.au
Jessica
J
Maskell
Peter
P
Newcombe
Graham
G
Martin
Roy
R
Kimble
D000293:Adolescent; D001315:Australia; D002053:Burn Units; D002056:Burns / Q000523:psychology / Q000534:rehabilitation*; D002648:Child; D003299:Cooperative Behavior; D003358:Cosmetics; D006801:Humans; D007221:Industry; D015278:Intensive Care Units, Pediatric; D007373:Interinstitutional Relations; D015337:Multicenter Studies as Topic; D009520:New Zealand; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
D003358:Cosmetics