The PROTECT platform

A national multi-centre platform trial for people on a surgical care pathway

Postoperative complications impair quality and quantity of life after surgery

Five million patients undergo surgery in the UK each year. One in five patients (800,000 people) develop postoperative medical complications including infections, respiratory failure and myocardial infarctions. Postoperative complications substantially reduce, and often neutralise, benefits of surgery for individual patients, decreasing both quality and quantity of life. However, the pipeline for identifying new treatments for postoperative complications is slow.

Traditional clinical trials are time-consuming and expensive

Traditional clinical trials utilise a two-group randomised design to answer a single research question. As a result, a typical perioperative clinical trial takes five years to conduct and two years to publish, with most treatments requiring several trials to generate definitive evidence. The capacity for patient inclusion is therefore limited by a system that is poorly optimised for patients and researchers.

Perioperative trials are poorly representative of society

Clinical trials under-represent key population groups. In many trials, diversity characteristics such as ethnicity and socioeconomic status, are poorly reported, which limits the generalisability of the results to the whole population. Patients tell us that key barriers are the burdensome consent and follow-up processes.

A platform trial for NHS surgical patients will rapidly transform perioperative care

Platform trials allow multiple treatments to be tested within the same clinical trial infrastructure, which greatly improves efficiency. New treatments are added periodically, mitigating lengthy administrative processes of repeatedly setting up separate trials and opening hospital sites, removing the biggest barrier to timely patient recruitment. National funders like the NIHR are investing in platform trials across multiple patient groups to leverage these benefits.

A UK national perioperative platform trial (PROTECT)

We are setting up an ambitious new perioperative platform trial (PROTECT). This national programme of research will provide an infrastructure for collaborative clinical trials and epidemiological analyses. This innovation will support the perioperative research community to answer important research questions, while remaining competitive with methodological advances from other specialty groups. We expect to start patient recruitment in 2025 and for the programme to continue for at least 10 years.