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

Area of Science:

• Paediatric Burn Scar Management
• Cosmetic Camouflage Research
• Psychosocial Functioning

Background:

• Multi-centred research offers benefits like larger sample sizes and enhanced statistical power.
• Implementing multi-centred studies involves numerous planning and execution considerations.
• This study focused on a cosmetic camouflage product for paediatric burn scarring.

Purpose of the Study:

• To review the challenges and successes of planning and implementing a multi-centred prospective randomised control trial.
• To investigate the impact of a cosmetic camouflage product on psychosocial functioning in children and adolescents with burn scarring.
• To outline lessons learned and recommendations for future multi-centred research involving industry partners.

Main Methods:

• A prospective randomised control trial was conducted across six Australian and New Zealand paediatric burn units.
• The study involved collaboration with an industry partner, introducing specific complexities.
• Ethical and institutional approval processes were navigated, involving multiple stakeholders.

Main Results:

• Collaboration with industry partners introduced complexities due to differing priorities and expectations.
• Navigating multifaceted ethical and institutional approval processes was a significant undertaking.
• The study identified challenges and successes in managing stakeholder expectations and research governance.

Conclusions:

• Effective multi-centred research with industry partners requires clear communication and defined roles.
• Recommendations include regular reporting to industry partners and prompt resolution of concerns.
• Utilising single ethical review where available and providing basic research education can streamline processes.