Clinical trials are a critical step in the drug development process. They ensure that a medication is safe and effective. To best understand how safe and effective a medication is, the patients participating in clinical trials should reflect the actual population of people living with the disease.
In the past, 60% to 70% of the participants in clinical trials were white men. This lack of diversity happened for many reasons, including bias in healthcare and barriers to care, such as cost and transportation.
A team of researchers developed a score called the “fair inclusion” score. A recent study from the American Society of Clinical Oncology (ASCO) Annual Meeting studied how recent clinical trials from 2018 to 2023 scored in diversity of gender, race, and age when compared to trials from 2012 to 2017.
How does the fair inclusion score measure clinical trial diversity?
The Fair Inclusion score measures two key areas:
Transparency: Whether sponsors publicly share detailed demographic information about participants (such as age, sex, race, and ethnicity).
Representation: Whether the proportions of enrolled women, older adults, Black, Asian, and Hispanic participants match the real-world U.S. population affected by that specific cancer.
This comprehensive study evaluated 80 trials that led to 75 U.S. Food and Drug Administration (FDA) cancer treatment approvals between 2018 and 2023. The researchers compared these results to data from 2012 to 2017 to see if diversity in cancer research has improved over time.
Transparency improved while actual diversity got worse or stayed the same
Public reporting on participant demographics increased significantly, with overall transparency reaching 95%. Reporting for older adults rose to 95% (from 78%), and for racial and ethnic minorities to 91% (from 67%).
Despite better reporting, patient diversity did not improve:
Racial/ethnic minorities: Representation dropped from 75% to 67%.
Older adults: Representation dropped from 85% to 81%.
Women: Representation remained unchanged at 94%.
Why did the fair inclusion score get better if actual diversity did not improve?
The "fair inclusion" score rose from 81% to 86%, but researchers confirmed this gain was caused entirely by better data sharing, not actual increases in patient diversity.
These results show a big difference between sharing information and making real progress. While organizations are doing a better job reporting who takes part in studies, this extra paperwork can make it look like things are improving when they are not. In reality, the actual enrollment of diverse patients is staying the same or dropping. Real progress requires actively recruiting a more diverse group of patients, not just publishing better data.
How patient inclusion makes medical advances possible
Every therapeutic breakthrough or improvement exists because real patients chose to participate in clinical research.
When clinical trials include people of all ages, genders, races, and ethnic backgrounds, researchers gain the vital data needed to understand how a drug works across diverse biological profiles. Diversity ensures that new treatments are proven safe and effective for every community, not just a subset of the population.
Your voice, your background, and your participation are what drive modern medicine forward. By taking part in research, patient participation and advocacy can help find better therapies, break down long-standing healthcare disparities, and pave the way for safer cancer care for future generations.
Organizations that can help support you through getting treatment in a clinical trial
HealthTree Foundation: With services like a Clinical Trial Finder, webinars about the latest clinical trials, and online and in-person events and support groups, HealthTree can help you at every part of your treatment in a clinical trial.
Organizations like HealthTree provide orientation for people who are looking for clinical trials. Other organizations can provide travel assistance and funding, for example:
Review the full list of financial and helpful resources we’ve compiled here.
Find a clinical trial tailored to you
Finding a trial that matches your unique medical history, background, and location should not be overwhelming.
Take an active role in your care by exploring the HealthTree Clinical Trial Finder. This free, easy-to-use tool lets you apply personalized filters to find clinical trials tailored to your needs.
