NHS-Galleri Trial: Awaiting Final Results

The NHS-Galleri trial, a study into the early detection of multiple cancers, is making strides but NHS England has opted to wait for the final results before considering a nationwide rollout. This cautious approach is based on the first year’s data, which, while promising, isn’t yet compelling enough for a swift, large-scale implementation. This trial’s progress is highly relevant to practice managers, who need to stay informed about potential advancements in screening protocols that could significantly impact patient care and operational efficiency in their practices

CREDIT: This is an edited version of an article that originally appeared on NHS England

Launched in November 2020, NHS England’s agreement with health tech company GRAIL brought the NHS to the forefront of medical innovation. Over 140,000 participants, aged between 50 and 77, are part of this three-year trial, the largest of its kind. The Galleri test works by detecting a common signal among more than 50 cancer types from a simple blood sample, potentially identifying cancers before symptoms appear.

Waiting for comprehensive results

The NHS-Galleri trial was designed with three consecutive years of screening, and it is vital to evaluate the primary objective and endpoints at the end of the study in 2026. The primary endpoint of the trial is an absolute reduction in the number of late stage (stage 3 and 4) cancers diagnosed, and cancer-specific mortality will also be analysed after five years of follow up.

Why the wait?

Many successful cancer screening trials have failed to show a stage shift initially, and it is frequently observed that the first-year data will differ from the final trial results.

NHS England has reviewed preliminary data from the first year of the NHS-Galleri trial and did not find them compelling enough to justify proceeding straight away with a large-scale pilot programme of the test in NHS clinical practice, while we await the final results of the trial. Committing to accelerate implementation of the test in the NHS at scale would have been an exceptional step, requiring exceptional data after just one year, and while what we have seen is very promising, the data so far do not support moving at such a fast pace.

It’s important to note that the preliminary data is not an early assessment of the trial’s primary endpoint. The first year data showed a high level of accuracy for the test, and we hope to see more evidence of test performance, earlier stage at diagnosis and improved outcomes once the trial has been completed.

Multi cancer early detection blood tests, like Galleri, are an exciting area of innovation that could become a key component of the NHS ambition to improve cancer diagnosis, and in doing so, help more people survive cancer.

The road ahead

Participants in the trial will continue their appointments until July 2024. These final screenings and subsequent diagnostic checks are crucial for a thorough evaluation of the test’s benefits. The ultimate decision on whether Galleri could be included in a national screening programme will be made by the UK National Screening Committee, based on the complete trial data.

Continued commitment to early detection

Despite the ongoing trial, the NHS is committed to enhancing cancer care as outlined in the NHS England Long Term Plan. Recent achievements include:

• The NHS exceeding its faster diagnosis cancer target in early 2024, amid record demand. Thanks to the hard work of NHS staff, nearly eight in 10 people received a definitive cancer diagnosis or the all clear within four weeks.
• In March 2024, we marked a milestone of 100,000 patients benefitting from faster access to cancer treatments through the Cancer Drugs Fund since July 2016.
• The NHS seeing over 3 million patients for vital cancer checks in a 12-month period for the first time in history: this is more than twice as many checks as were carried out a decade ago.

The potential of the Galleri test remains significant. If results are favourable, the NHS plans to make this innovative test available to more people rapidly, ensuring that patients are the first to benefit from new technologies. Until then, the focus remains on completing the trial and continuing to improve cancer detection and treatment through existing initiatives. Understanding these advancements allows managers to better prepare their teams and systems for potential new screening protocols, ultimately improving patient outcomes and operational efficiency.