Diversity, equity and inclusion (DE&I) are fundamental principles that drive positive change and progress in various aspects of society. These principles recognise and celebrate the unique characteristics and experiences of individuals, ensuring fair representation, equal access, and opportunities for all.
In the context of clinical research, diversity refers to the inclusion of individuals from various demographic backgrounds, including race, ethnicity, gender, age, socioeconomic status, and more.
Recognition and inclusivity of transgender individuals
Inclusivity entails creating an environment that respects and embraces differences, fostering a sense of belonging and ensuring that all individuals have a voice and are heard. Equity goes beyond equality by addressing systemic barriers and providing fair and just opportunities, resources, and outcomes to individuals regardless of their backgrounds. By embracing diversity, equity and inclusivity, we promote a more comprehensive and accurate understanding of health and disease, improve healthcare outcomes, and advance towards a more equitable and just society for all.
The US has 16 lakh transgender people and in the UK, around 2.62 lakhs.1 There are 4.8 lakh transgender people in India, according to the 2011 census, but campaigners believe the true number may be closer to 15 lakhs. The National Portal for Transgender Persons, established in 2020 by the Department of Social Justice & Empowerment, has provided much-needed relief to the transgender community to receive the necessary acknowledgement in India.1, 2
Health for all, including the transgender community
Diversity, equity and inclusion in clinical trials are not just desirable but essential for several reasons. Firstly, every individual, regardless of their gender identity, deserves equal access to healthcare and the opportunity to participate in research that directly impacts their well-being. By including diverse populations in clinical trials, we can ensure that the benefits of medical advancements apply to everyone, including transgender individuals.
Secondly, excluding transgender individuals from clinical trials hinders our understanding of their specific healthcare needs. Transgender individuals often face unique health challenges related to hormone therapy, surgical interventions, mental health, and more. Without their representation in research studies, we miss valuable insights into effective treatments and interventions tailored to their needs. Comprehensive data from diverse populations is crucial for evidence-based medical practice and the development of inclusive healthcare policies.
Thirdly, promoting diversity, equity and inclusion in clinical research is a matter of social justice and human rights. Transgender individuals have historically been marginalised and faced discrimination within the healthcare system. By actively addressing the underrepresentation of transgender individuals in clinical trials, we can challenge and overcome systemic biases, promoting a more just and equitable society.
Addressing challenges in DE&I
To achieve diversity and inclusivity in clinical trials, it is essential to raise awareness and advocate for increased education among healthcare professionals. By enhancing their understanding of the healthcare needs of transgender individuals, we empower healthcare providers to deliver more competent and sensitive care. This can be achieved through incorporating transgender-specific healthcare education into medical school curricula, offering ongoing training opportunities, and fostering a culture of respect and inclusivity within healthcare organisations.
However, several roadblocks hinder the participation of transgender people in clinical trials. One significant challenge is the burden placed on transgender individuals due to numerous medical appointments. Hormone therapy, surgeries, and regular monitoring of health create a time-consuming and costly commitment, making it difficult for them to participate in lengthy clinical trials that require frequent visits. Addressing this challenge requires innovative trial designs, such as remote monitoring or flexible scheduling options, to minimise the burden on participants.
Parexel’s report on gender identity report, Beyond the Binary: Navigating Gender Diversity in Clinical Research, provides valuable insights into creating more equitable clinical trials for transgender and nonbinary patients. The report identifies five roadblocks to participation: lack of awareness and understanding, logistical challenges, mistrust and safety concerns, limited recruitment strategies, and limited data collection and reporting. It also offers eight solutions, including raising awareness and education, streamlining logistics, building trust and ensuring safety, implementing diverse recruitment strategies, and improving data collection and reporting.
The way forward – towards true DE&I
As the world recognises the urgency to foster inclusivity and promote equitable clinical trials, we must work collaboratively with healthcare providers, researchers, advocacy groups, and the transgender community to implement these solutions. By addressing roadblocks and striving for inclusivity, we can create clinical trials that reflect the diversity of our population, generate more robust evidence, and ultimately improve healthcare outcomes for all individuals, including transgender and nonbinary patients.
2. They thought I was a curse’: The struggles of India’s trans community. Accessed from: https://www.opendemocracy.net/en/5050/india-transgender-discrimination-health-gender-affirmation-surgery/
3. The Transgender And Unemployment In India. Accessed from: https://www.outlookindia.com/national/transgender-and-unemployment-in-india-news-182617
4. Overcoming obstacles in trans and nonbinary participation in clinical trials. Accessed from: https://www.clinicaltrialsarena.com/news/transgender-clinical-trials/