Tiptop

Testing interventions in pregnancy and the newborn, trials in one platform

Trial started: 2023  Trial ended: 2024 

Summary

Objectives

To design and deliver a novel perinatal platform to efficiently evaluate the clinical- and cost-effectiveness of multiple comparisons concurrently, recognising the inextricable link between pregnant women and babies.

Methods

Extensive groundwork was undertaken, including discussions, focus groups and statistical simulations to explore and develop the methodology required to deliver a platform of trials. This included building sustainable partnerships across disciplines with expertise in perinatal and platform trials; developing governance processes for selecting comparisons through multi-stakeholder oversight; establishing project delivery processes; developing IT systems and frameworks for data collection and data flows; working with parents, women and national charities to ensure integral public involvement; exploring healthcare professionals' views on the design and conduct of a perinatal platform trial; and developing and refining the required methodologies.

Results

The main output from the accelerator award was a Stage 1 application to NIHR for a perinatal platform trial, which was unsuccessful. The breadth of the network and planned work presented many challenges; however, the work demonstrated that collaboration across several clinical trials units and institutions is possible.

Conclusions

The work identified institutional, governance, legal and financial challenges associated with establishing a perinatal platform trial. An agile infrastructure was developed that would allow new comparisons to be added, although creating a futureproofed infrastructure requires considerable upfront investment, offsetting some of the efficiencies promised by platform trials. None of the challenges identified were considered insurmountable, and the work created a blueprint for the design and conduct of streamlined perinatal trials.

Adapted from: Juszczak E, Hardy P, Bradburn M, et al. Accelerating the development of a perinatal platform trial to efficiently evaluate the effectiveness of multiple interventions in perinatal care. NIHR Open Research. 2026;6(80). https://doi.org/10.3310/nihropenres.14207.1. Licensed under the Creative Commons Attribution 4.0 International (CC BY 4.0) Licence (https://creativecommons.org/licenses/by/4.0/). Adapted for presentation on this website.