October was World Breast Cancer month and was a chance to reflect on progress in tackling the disease and celebrating some of the leading influencers in the field. While great strides have been made in breast cancer research and care, it’s important to recognize that many regions of the world are still disadvantaged when it comes to treatment and access to expertise.

Recent data¹ from the World Health Organization’s International Agency for Research on Cancer (IARC), showed that by 2050 there will be 3.2 million new breast cancer cases and 1.1 million breast cancer-related deaths per year. That’s a respective 38% and 68% rise, with the increase disproportionately affecting low human development index (HDI) countries. The report notes that high-quality cancer data, continued progress in early diagnosis and better access to treatment are needed in countries with low and medium HDI to address these inequities.

Why, then, are there so few breast cancer clinical trials taking place in these regions? Low- and middle-HDI countries would benefit greatly from clinical trial expertise, but new data highlights how vast this global disparity remains. An analysis from Phesi reveals that breast cancer clinical trial expertise is disproportionately concentrated in just two countries, the US and China. This is particularly shocking considering that breast cancer has been the most studied disease in the world² for the last four years.

Access to Key Opinion Leaders (KOLs)

Phesi analyzed 514 interventional, published trials sponsored by 114 pharmaceutical companies over the past 10 years, drawing from 19,321 records in the Trial Accelerator platform. Within this analysis, we identified 256 leading investigators (Key Opinion Leaders, or KOLs) in 24 countries who have led more than five clinical trials each; the top ten KOLs are named in fig.1. These expert clinicians and researchers have deep knowledge and strong clinical trial track records, and their insights shape study design and the eventual adoption of new therapies.

Of those 256 KOLs, 76 (30%) are based in the US and 39 (15%) in China. That means that 45% of all leading breast cancer experts identified are based in just two countries, with Spain, Japan and Germany rounding out the top 5.

What does this mean for clinical development?

While it is encouraging to see so much research activity, with some fantastic achievements from those in the top 10, the data clearly show that patients in regions most affected by rising breast cancer mortality still lack proportional access to innovative clinical trials. Instead, the concentration of KOLs and trials in specific regions suggests that sponsors often default to the same investigator sites rather than identifying the locations best suited to each trial.

This is problematic, because breast cancer is increasingly recognized as a complex disease defined by multiple biomarkers, including Luminal A and B, HER2-positive and Triple-Negative (TNBC), among many other subtypes. At a population level, trends in breast cancer differ significantly. Meta-analyses show that³ TNBC is more common in women from Sub-Saharan Africa; in some West African countries, more than 40% of breast cancer cases are TNBC, compared with around 10–15% in most Western populations. Further analyses indicate that⁴ in parts of South Asia, around 27–31% of breast cancers are TNBC and 31% are HER2-positive.

The main takeaway is that selecting investigators and KOLs who can access and recruit patients with those specific subtypes of breast cancer, regardless of geography and rather than defaulting to historical investigator sites, is critical. As noted, breast cancer is the most studied disease in the world and remains a dynamic field with extensive clinical development activity. Among those conducting today’s trials will emerge the next generation of KOLs. For trial sponsors, with help from clinical data science, the ability to precisely identify experts with experience in the relevant subpopulations and across a broader range of geographies will be an important factor in driving trial success.

The role of AI and clinical data analytics

Adopting a global data-driven strategy will deliver a more precise approach to KOL and investigator site selection. Sophisticated clinical data analytics, when combined with AI, enable sponsors to accurately profile both patients and treating clinicians, matching the right patients with high enrolling investigator sites. Rather than zeroing in on the same investigator sites, sponsors can identify investigators with relevant biomarker experience and the right profile of patients. And in the case of the US market, enabling the enrollment of target patients such as US patients and other subpopulations of interest. Even in low HDI countries, AI enabled clinical data science can guide sponsors to local breast cancer experts, allowing the industry to reach patients in dire need, and easing the challenges of fierce competition for eligible patients––a win-win for both the industry and local medical communities.

Even more advanced approaches will use the huge volume of real-world breast cancer patient data available to create digital patient profiles and twins to simulate trials and predict outcomes in responder and non-responder groups. Digital twins reduce the burden on patients and investigators while allowing sponsors to model and simulate trials before they begin, accurately predicting challenges in recruitment and moving towards using a digital control arm.

This strategy has two clear benefits. First, optimized, efficient and successful trials with reduced cost. Secondly, and most importantly, it ensures breast cancer clinical development is truly patient centric. A more patient centric approach to investigator site selection and recruitment is likely to better take into account those countries where the subtype of breast cancer under study is most prevalent.

WHO’s data should not be ignored. Huge challenges remain in breast cancer, and it will take global collaboration to address them. But as technology and data science evolves, there are also more opportunities than ever to improve all patients’ access to expertise, and in doing so uncover faster cures, for more types of breast cancer, for more patients.

Sources

1. https://www.nature.com/articles/s41591-025-03502-3
2. https://www.phesi.com/news/2024-most-studied-diseases/
3. https://ascopubs.org/doi/pdfdirect/10.1200/GO.23.00135
4. https://ascopubs.org/doi/pdf/10.1200/JGO.2016.005397