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

Jessica Maskell1, Peter Newcombe, Graham Martin

  • 1Department of Paediatrics and Child Health, The University of Queensland, Brisbane, Australia. jessica.jameschadwick@uqconnect.edu.au

Journal of Paediatrics and Child Health
|August 16, 2012
PubMed

Insights

Conducting multi-centred research with industry partners presents unique challenges. This study highlights key considerations for successful collaboration, ethical approvals, and managing expectations in paediatric burn scar research.

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.

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