Maskell Jessica, Newcombe Peter, Martin Graham, Kimble Roy
Department of Paediatrics and Child Health, The University of Queensland, Brisbane, Australia.
J Paediatr Child Health. 2012 Nov;48(11):974-7. doi: 10.1111/j.1440-1754.2012.02510.x. Epub 2012 Aug 14.
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.
多中心研究有诸多益处，包括大样本量、统计效能、及时招募以及结果的可推广性。然而，在规划和实施多中心研究时需要考虑众多因素。本文回顾了规划和实施一项涉及行业合作伙伴的多中心前瞻性随机对照试验的挑战与成功之处。该研究调查了一种用于有烧伤疤痕的儿童和青少年的美容遮瑕产品对心理社会功能的影响。多中心研究通常有许多利益相关者。在本研究中，涉及六个澳大利亚和新西兰的儿科烧伤病房以及一个行业合作伙伴。纳入一个行业合作伙伴增加了复杂性，因为他们给研究带来了不同的优先事项和期望。此外，需要协商多方面的伦理和机构审批程序。将概述本研究在澳大利亚和新西兰伦理及研究管理审批程序、与行业合作伙伴的合作以及不同期望的管理方面的挑战、成功经验、吸取的教训和建议。对未来与行业合作伙伴进行多中心研究的建议包括为行业合作伙伴提供定期书面报告；持续监测并迅速解决问题；为行业合作伙伴开展基础研究实践教育；尽量减少行业合作伙伴与参与者的接触；明确所有利益相关者的角色和责任以及若可行则采用单一伦理审查。
