The challenge
Clinical trials are essential, but they don't always reflect the full diversity of patients seen in routine care. Age, comorbidities, tolerability, and the pressures of everyday oncology services all shape how treatments are delivered in practice, in ways that trial data rarely captures.
For high-risk hormone receptor-positive early breast cancer, adjuvant abemaciclib has become an important treatment option following the monarchE trial. But prior to CONCISE, large-scale UK real-world data on how the therapy was actually being used — and how patients were tolerating it — was limited.
“Working as clinicians for cancer patients we know that data across hospitals, regions and countries are often siloed. So much fragmentation when it comes to spreadsheets, paper and systems. This fragmentation limits research and our ability to improve services for patients.Collaboration across institutions is slow and administratively heavy,” said Dr Ayodele of the challenges.
The clinical question was clear. The infrastructure challenge was significant. Bringing together 21 NHS Trusts across four nations, each with their own governance requirements and data systems, required a consistent, secure, and practical approach to data collection.
The solution
Using Ledidi Core, the CONCISE team built a harmonised national dataset covering tumour characteristics, treatment details, dose modifications, toxicities, and follow-up outcomes in Ledidi Core. Ledidi removed many of the barriers you would typically see in multi-site settings. Each participating Trust contributed directly to a central, structured registry, removing the need for disconnected spreadsheets, manual consolidation, or complex local installations. Role-based access controls and local governance were built into the platform from the outset.
As Dr Ayodele put it: "Something of that scale would have taken almost a year to put together using conventional methods like spreadsheets or site-specific databases. But with Ledidi, we were able to do this in about 4 months”.
What the study found
The dataset had national representation across clinical settings. Across more than 1,000 patients, the median treatment duration was 15.5 months. A quarter of patients completed the full two-year course, while 54.9% remained on ongoing therapy at data cut-off — a meaningful persistence signal in a real-world population. Where patients did stop early, toxicity was the primary driver in the large majority of cases, and dose modifications were common, with nearly two-thirds of patients requiring at least one reduction. The overall adverse event profile was broadly consistent with trial data, though with a wider and more diverse patient population.
A dedicated subgroup analysis of patients aged 65 and over — around a fifth of the full cohort — was among the most clinically instructive elements of the programme. Treatment persistence dropped and early discontinuation due to toxicity rose markedly in the oldest patients, particularly those aged over 75. The monarchE trial included very few patients in this age bracket and offered no dedicated geriatric safety analysis, and left a gap that CONCISE was well-placed to address with real-world evidence.
The findings point to practical conclusions: older patients benefit from geriatric assessment before starting therapy, proactive toxicity monitoring, and early comfort with dose titration. These aren't novel ideas in oncology — but having UK real-world data to support them gives clinicians something concrete to act on.
Impact
Beyond the specific findings, CONCISE is a proof of concept for what multicentre clinical audit can look like when the data infrastructure is right. It brought together 21 Trusts from four nations and collected data on more than 1,000 patients in a single, structured registry, with the data analysed directly within the platform rather than extracted and reconciled elsewhere. At the time of writing, the CONCISE team is already updating their datasets, and can get analysis results immediately through the real-time dashboards in Ledidi.
The study created a reusable framework for future collaborative audits — and a template for what national real-world evidence generation can look like in practice. CONCISE demonstrates that the evidence clinicians need most — from patients who look like the ones they actually treat — doesn't have to wait for the next trial. It can be built, systematically, from the care already being delivered. “I feel like Ledidi is such a platform that helps to leverage equality so whatever data you are getting you can standardize your results and see them on the dashboard,” said Dr Ayodele.