Conducting a paediatric multi‐centre RCT with an industry partner: Challenges and lessons learned

Abstract

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.

Ethics and governance for a multi‐site study in Australia: Navigating the snakes and ladders

“…3,4 However, obtaining approvals to conduct multi-site studies can be complex, bureaucratic and time consuming compounded by inconsistencies among ethics and governance committees within and across sites. [4][5][6][7][8] Despite multi-site research being desirable and valuable, the working tone of institutional ethics committees has been described as 'quasi-constabulary', which may lead to a 'them' versus 'us' footing for researchers. 9 This paper describes the process of obtaining research ethics and governance approvals for a multi-site study in Australia.…”

“…These allow researchers to pool resources, funding and expertise, attract larger and more representative study samples and are likely to have more scientific rigour and applicability than single‐centre studies 3,4 . However, obtaining approvals to conduct multi‐site studies can be complex, bureaucratic and time consuming compounded by inconsistencies among ethics and governance committees within and across sites 4–8 . Despite multi‐site research being desirable and valuable, the working tone of institutional ethics committees has been described as ‘quasi‐constabulary’, which may lead to a ‘them’ versus ‘us’ footing for researchers 9 …”

Trends in collaboration with patient organizations on cancer-related clinical trials: Collaborative relationship with existing stakeholders and the characteristics of their co-sponsored studies in the United States

“…As con rmed in previous studies, "Accrual/Feasibility" is the most crucial issue for most sponsors when conducting clinical trials [45,46] It was not surprising that IND sponsors with the lowest budget-related early termination were likely to conduct a larger multi-center study. This could improve patient recruitment and achieve a larger sample size to increase statistical power [50,51]. However, this also brings scienti c and operational challenges, such as standardizing a process across sites [52][53][54].…”