Let the Science Lead: Why Inclusion in Clinical Trials Matters This Pride Month

We are reminded that visibility and representation are more than symbols—they are necessities. 

Nowhere is that more critical than in clinical research. Because at its core, clinical research is about people—about patients. Behind every trial protocol and patient ID is a human being.

These individuals are the heart of medical progress. And yet, for far too long, clinical trials have failed to reflect the full spectrum of those they aim to serve. Historically, participation has been skewed toward white, cisgender, able-bodied men—leaving women, people of colour, LGBTQIA+ individuals, and other underserved communities underrepresented in the data. 

If we want safe, effective, and equitable treatments for all, we must ensure that everyone is represented in the research. Inclusion in clinical trials isn’t just about fairness—it’s about better science.

The Problem: Who’s Been Left Out of the Data?

This long-standing lack of representation has real consequences. When trials fail to reflect the diversity of the broader population, the data may not fully capture how different people respond to treatment—leading to gaps in safety, efficacy, and trust.

This imbalance has deep historical roots. For example:

• In 1997, the U.S. FDA reported that fewer than 20% of participants in early-phase clinical trials were women, despite clear sex-based differences in disease progression and drug response.
  
  
• A 2020 study in JAMA Oncology found that Black patients accounted for only 3.1% of participants in cancer clinical trials, even though they represent over 13% of the U.S. population.
  
  
• According to Clinical Leader, as of 2022, fewer than 1% of clinical trials collected data on gender identity or sexual orientation, limiting insights into how treatments affect LGBTQIA+ individuals.

This lack of representation doesn’t just skew the data—it compromises the safety, effectiveness, and relevance of the treatments developed. For instance, women are nearly twice as likely as men to experience adverse drug reactions, in part because many dosage guidelines are still based on male physiology.

Inclusion in clinical trials is not just a fairness issue.
It’s a scientific imperative. 

When diversity is lacking, so is our ability to generate accurate, generalizable, and actionable results. We risk developing therapies that fail to serve the people who need them most. And that’s not just inequitable—it’s unsafe.

What Inclusion Looks Like in Action

Inclusion means more than checking a box or broadening eligibility criteria. It means building trials intentionally—with equity, access, and representation at the core. That includes:

• Designing protocols with diverse patient populations in mind
  
  
• Reaching underrepresented communities through culturally relevant outreach
  
  
• Collecting data on gender identity, sexual orientation, and social determinants of health
  
  
• Reducing logistical barriers through decentralized models and flexible IRT solutions
  
  
• Centering the voices of patients and adapting based on their lived experiences

Technology plays a critical role in making this possible. Flexible IRT systems, decentralized trial platforms, and tools that support hybrid designs can help reduce the burden on patients, increase access for those in remote or underserved areas, and ensure supply chains meet the needs of specialized therapies.

Inclusion must be built into the trial framework—not added as an afterthought. When we use technology to meet patients where they are, we move closer to a research model that reflects the real world.

Pride Month: A Moment to Reaffirm Our Commitment

This month—and every month—we reaffirm our belief that diversity strengthens not just our teams and our culture, but our science.

• True innovation happens when everyone is represented.
  
  
• True equity happens when everyone is included.
  
  
• True progress happens when no one is left behind.
  
  

If we want clinical trials to serve all patients, then all patients must be represented in research.