Is Ignoring Gender Non-Conformity Research Holding Us Back?

By Darshan Kulkarni, Pharm.D., MS, Esq., principal attorney, Kulkarni Law Firm, and host of Darshan Talks podcast

The medical landscape is shifting away from the "one size fits all" approach, with the FDA paying more attention to the collection of race and ethnicity data and opining about enhancing the diversity of clinical trial populations. While much has, appropriately, been made of the collection and sharing of race and gender data, the conversation is beginning to pivot toward the collection and sharing of data regarding sexuality, gender identity, and gender expression. According to data from the Behavioral Risk Factor Surveillance System, over 1.6 million adults (ages 18 and older) and youth (ages 13 to 17) identify as transgender. This data therefore suggests that while the number and percentage of adults who identify as transgender in the U.S. has remained steady over time, the number of youths who identify as transgender has nearly doubled. Drug and device manufacturers must give serious consideration to this evolving demographic as they continue to research drugs and devices. Including individuals across the gender spectrum in clinical trials isn't just a social justice issue, it's a strategic move with tangible benefits for both research and sponsors. Let's explore how:

Enhanced Efficacy And Precision Medicine
Beyond traditional demographic markers, individual health experiences vary according to factors like gender identity and expression. In this section, we explore how embracing diverse data collection can unlock enhanced efficacy and precision medicine. By delving into the nuances of how treatments impact different gender identities, we can achieve the following goals:

• Unveiling hidden nuances: Recent research demonstrates that male and female brains are indeed “wired differently”. By analyzing data from a diverse pool, researchers can uncover subtle variations in how treatments affect different gender identities. This leads to a deeper understanding of efficacy and potential side effects, ultimately leading to more personalized and effective therapies and better adherence of an approved product.
• Reduced trial failures: Failing to recognize these nuances can lead to skewed results and costly trial failures. Inclusion can prevent this, saving sponsors significant financial resources and time.
• Optimizing dosages and formulations: Tailoring treatments based on gender expression can optimize dosages and formulations, improving compliance and reducing wasteful overdosing.

Expanded Market Reach And Revenue Potential

While focusing on existing markets holds inherent value, true innovation often lies in exploring unmet needs beyond traditional boundaries. For sponsors looking to amplify their impact and expand their reach, partnering with initiatives that address the health needs of marginalized communities like gender non-conforming individuals presents a powerful opportunity. This impact will be felt in the following ways:

• Meeting unmet needs: Addressing the unique health needs of marginalized communities opens up a previously untapped market for sponsors, leading to increased revenue potential.
• Enhanced brand reputation: Demonstrating inclusivity strengthens brand image and attracts ethically-conscious consumers, leading to stronger brand loyalty and potential partnerships.
• Early access to emerging markets: As previously discussed, transgender individuals represent an emerging and unsupported audience. Including such a diverse population early on positions sponsors well for successful expansion into new, emerging markets with similar demographics.

Improved Recruitment And Retention

The success of clinical trials hinges on the engagement and participation of a diverse pool of individuals. However, traditional recruitment methods often fall short in reaching underrepresented communities. Actively including marginalized populations in clinical research unlocks several key benefits for clinical research, including:

• Building trust and engagement: Active inclusion fosters trust and strengthens relationships with underrepresented communities, leading to increased willingness to participate in trials.
• Diversifying recruitment channels: Targeting specific communities through tailored outreach efforts expands the pool of potential participants, lowering recruitment costs and timelines.
• Reduced participant bias: Diverse trial populations minimize the risk of selection bias, leading to more generalizable and reliable results.

Boosting Innovation And Scientific Advancement

Innovation requires looking beyond the present and anticipating the future needs of diverse populations. Embracing inclusivity fuels not just progress but scientific advancement itself.

• Staying ahead of the curve: As societies become more inclusive, anticipating and addressing evolving needs keeps sponsors at the forefront of medical progress.
• Attracting top talent: A commitment to inclusivity attracts talented researchers who value diversity and social impact, strengthening the overall research ecosystem.

Incorporating diverse gender expressions is not just the ethical choice, it's a smart business decision for clinical trial sponsors. By unlocking the full potential of a diverse participant pool, sponsors gain access to a wider market, improve research quality, and contribute to the development of lifesaving treatments that truly benefit everyone. Embracing this shift isn't just about being trendy, it's about building a brighter, healthier future for all.

About The Author

Darshan Kulkarni, PharmD, MS, Esq., is the principal attorney at the Kulkarni Law Firm, known for its dedication to legal excellence in the pharmaceutical industry. An entrepreneur and an innovator, Kulkarni serves as an adjunct professor at Drexel University School of Law. He serves on multiple boards including the board of the Emily Whitehead Foundation, contributing to transformative work in pediatric cancer research. Beyond his legal and academic commitments, Kulkarni hosts the DarshanTalks podcast. on misconduct management in the life sciences including clinical research issues, promotional compliance issues, due diligence issues etc.