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Olubukola Ayodele: Bridging Clinical Trials and Real-World Evidence in Breast Cancer Care

Olubukola Ayodele/LinkedIn

Aug 9, 2025, 08:48

Olubukola Ayodele: Bridging Clinical Trials and Real-World Evidence in Breast Cancer Care

Olubukola Ayodele, Consultant Medical Oncologist at the University Hospitals of Leicester NHS Trust and Breast Cancer Clinical Trials Lead at Leicester Cancer Research Centre, shared a post on LinkedIn:

“As a breast oncologist, I rely on clinical trials to guide treatment decisions. However, real-world evidence (RWE) has become an increasingly valuable tool in understanding how therapies perform outside the controlled environment of a trial.

Randomized Controlled Trials (RCTs) remain the gold standard for evaluating new treatments, providing rigorous, high-quality data. But they come with limitations: strict eligibility criteria often exclude patients with comorbidities, older adults, or those from diverse racial and socioeconomic backgrounds. As a result, trial populations may not fully represent the patients we see in clinic every day.

This is where RWE steps in. By leveraging data from real clinical practice, including electronic health records, patient registries, and sometimes insurance databases, RWE helps us bridge the gap between clinical trials and real-world patient outcomes. In breast cancer, RWE has been instrumental in:

Identifying treatment effectiveness in broader populations, including those ineligible for RCTs.
Understanding long-term safety and adverse effects beyond the duration of a trial.
Evaluating real-world adherence to new therapies and their impact on survival.
Supporting regulatory decisions and accelerating drug approvals, particularly for rare breast cancer subtypes.

For example, post-market studies using RWE have provided critical insights into CDK4/6 inhibitors, shedding light on their use in older patients and those with pre-existing conditions, data we wouldn’t get from RCTs alone.

Yet, challenges remain. Unlike RCTs, real-world data is not randomized, meaning potential biases must be accounted for. Data accuracy, missing information, and standardization issues require robust statistical methodologies to ensure reliability. However, with advancements in AI, machine learning, and large-scale databases, we are getting closer to deriving high-quality, real-world insights that complement traditional trials.

As oncology continues to evolve, integrating RWE into our decision-making will enable more personalized, evidence-based care for our patients. The future lies in a hybrid approach, leveraging both RCTs and RWE to drive innovation and improve cancer outcomes.