DOI: 10.3310/nihropenres.14207.1 ISSN: 2633-4402

Accelerating the development of a perinatal platform trial to efficiently evaluate the effectiveness of multiple interventions in perinatal care.

Edmund Juszczak, Pollyanna Hardy, Mike Bradburn, Christina Cole, Jane Daniels, Munyaradzi Dimairo, Linda Fiaschi, Chris Gale, Hayley James, Samantha Johnson, Andrew King, Marian Knight, Caroline Lee-Davey, Paul Leighton, Faye Martin, Garry Meakin, Eleanor Mitchell, David Murray, Shalini Ojha, Christopher Partlett, Rachel Plachcinski, Oliver Rivero Arias, Charles Christoph Roehr, Julia Sanders, Nigel Simpson, Kayleigh Stanbury, Kate Walker, Richard Welsh, Jon Dorling
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Background We aimed to design and deliver a novel, ambitious perinatal platform to efficiently evaluate the clinical- and cost-effectiveness of multiple comparisons concurrently, recognising the inextricable link between pregnant women and babies. Methods We undertook extensive groundwork, holding discussions, focus groups, and conducting statistical simulations to explore and develop methodology to deliver a platform of trials. This included: 1. building sustainable partnerships across disciplines with expertise in the delivery of perinatal and platform trials 2. developing governance processes for selection of comparisons by multi-stakeholder oversight 3. setting up all aspects of project delivery 4. developing the IT systems/framework for data collection processes/data flows 5. working with parents, women and national charities to ensure integral public involvement 6. exploring views of healthcare professionals about the design/conduct of a perinatal platform trial 7. developing/refining required methodologies Results The main output from the accelerator award was a Stage 1 application to NIHR for a perinatal platform trial. Unfortunately, our bid was unsuccessful. The breadth of the network and of the planned work presented many challenges. However, we showed that collaboration across several clinical trials units/institutions is possible. Conclusions As long as institutions and individual researchers are primarily judged by research income, competition inevitably makes such endeavours complicated. Governance and legal aspects have yet to evolve sufficiently to reassure host institutions regarding risk management across multiple studies and institutions. It was imperative that our proposed platform allowed adaptations beyond adding or removing interventions. We created an agile infrastructure whereby new comparisons could be added. However, developing such an infrastructure that is futureproofed requires considerable upfront investment, which offsets many of the efficiencies that platform trials promise. None of these challenges were insurmountable. We have created a blueprint for the design and conduct of streamlined perinatal trials.

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