June 17, 2022
In the United States, we celebrate Juneteenth National Independence Day and LGBTQIA+ Pride Month in June. TRiNDS reflects each year upon the need to combat racism and anti- LGBTQIA+ bias in our work to support high quality clinical research to rare neuromuscular disease communities.
The history of clinical research in the US has been shaped by racism. Most Human Subjects Protection training courses review the United States Public Health Service (USPHS) Syphilis Study at Tuskegee, which recruited black male participants in a deceptive manner without obtaining informed consent. Researchers denied participants access to available treatments for their syphilis, resulting in permanent harm. The horrific experiences of this study fundamentally reshaped how US human subjects research is conducted, regulated, and supervised. In 1976, the first articles were published about the creation of an immortal cell line from samples taken without informed consent from a black woman, Henrietta Lacks. The HeLa cell line has been foundational to cancer research and has resulted in thousands of patents without compensation to the family. The Lacks family founded the Henrietta Lacks Foundation in 2010 to help families impacted by clinical research performed without the participants’ knowledge or consent.
US clinical care and clinical research for LGBTQIA+ people have been no better. The American Psychological Association (APA) removed “homosexuality” from the Diagnostic and Statistical Manual of Mental Disorders (DSM) only in 1973. The World Health Organization (WHO) removed same-sex attraction from the International Classification of Diseases (ICD-10) only in 1990. Classification of gender identity and sexual orientation as a diagnosis prevents inclusion in clinical trials and provision of evidence-based medicine. For example, despite conclusive clinical evidence that it is harmful and ineffective, only a handful of US states have banned conversion therapy.
This history continues to impact trials today. Clinical trials disproportionately enroll white, male, cisgender, heterosexual participants. Clinical trials which do not enroll participants representative of the patient population risk drug approvals based on incomplete safety and efficacy profiles. Enrolling diverse populations in clinical trials is critical, and requires addressing participants’ distrust of researchers, medical providers, and government agencies resulting from their past and current maltreatment.
We at TRiNDS are committed to conducting ethical, humane, and inclusive clinical research. Our team is required to complete regular training in human subjects protection and Good Clinical Practices so we can ensure our work is in compliance with the regulations for conducting ethical research. Our patient-centered model means that our work is to partner with communities to create and run trials that meet the needs of all eligible patients, not just the people who are easy to find. From the language we use in documents, to the sites we select, to the volunteer work we do – we work to give everyone a voice in research.
TRiNDS is a contract research organization (CRO) dedicated to conducting rare and neuromuscular disease research. TRiNDS offers expert research and clinical trial services to sponsors and researchers around the world from project launch to closeout. TRiNDS employees enjoy a competitive benefits package, supportive and inclusive work environment, personal mentoring, continuing education opportunities, and contributing to projects that matter. Contact TRiNDS today to learn more about how you can get involved.
