Participants in breast cancer clinical trials are getting younger. What does this mean for the future of clinical trial design?

Date: 05. 25. 2022

Number of young trial participants has tripled

This month, Phesi’s data revealed some fundamental insights into the changing landscape of clinical trials. Our analysis of more than 2.5 million breast cancer patients found that since 2014, the number of women younger than 60 years of age participating in clinical trials has increased dramatically, from 30% to 90%. Our analysis has paved the way for some well overdue conversations about patient centricity in clinical trials as we reflect on what this finding means for trial sponsors.

Putting patient centricity first

Breast cancer was the most studied disease in 2021 – with a total of 25,000 investigator sites recruiting for breast cancer drug development. With the increase in younger women participating in breast cancer trials, it’s time for sponsors to take into account new considerations for trial design. These include comorbidities and medication history, but also considerations specific to young women – such as potential fertility and pregnancy issues.

It’s unsurprising that we’re seeing more younger women participating in breast cancer trials – this pattern goes hand in hand with progress we’ve made in the disease area in recent years. For instance, we’ve seen increased mammogram screenings, as well as a number of successful public health awareness campaigns.

We’ve made great progress in the past few years, but as more younger patients participate in clinical trials, we have the potential to make even more headway. As earlier diagnosis of breast cancers becomes more common, we have the opportunity to identify the disease and intervene sooner. This will enable the industry to develop treatments that target more aggressive forms of breast cancer (more commonly found in younger patients).

To allow us to develop new treatments that extend the survival rates of a younger demographic, a deeper analysis of existing patient and trial data is needed to better identify multiple cohorts of patients that match protocols for younger patients. It’s also crucial that clinical trials are designed considering the requirements and complexities of this changing patient profile.

By unlocking insights within existing big data, and keeping patient centricity at the heart of clinical development, we have the potential to bring treatments to patients faster, as well as tackling more aggressive forms of cancer. More information on breast cancer biomarker trends can be found in the full report, here:

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