If certain patient populations are not included in clinical research, they are then not part of the evidence base used to formulate treatments for their particular condition and their unique experiences.
“The explicit exclusion and implicit non-inclusion of marginalized populations in clinical research limits the generalizability of research findings and withholds the benefits of research from those not involved,” wrote Carl G. Streed Jr., MD, MPH, in describing the problem his research is trying to solve.
Much of his research has been as a member of the AMA Medical Justice in Advocacy Fellowship program’s second cohort.
The fellowship is an initiative created by the AMA Center for Health Equity and Morehouse School of Medicine’s Satcher Health Leadership Institute to empower physician-led advocacy that advances equity and removes barriers to optimal health for marginalized people and communities.
“Without the data, we develop tools that are imprecise and we're not able to live up to the promise of precision medicine,” Dr. Streed said in an interview at the 2023 AMA Interim Meeting, where he presented his fellowship capstone project. He is an assistant professor at Boston University Chobanian and Avedisian School of Medicine and the research lead for the GenderCare Center at Boston Medical Center.
In addition, Dr. Streed has chaired the AMA Advisory Committee on LGBTQ+ Issues, served on the board of GLMA: Health Professionals Advancing LGBTQ+ Equality, and serves as an alternate delegate for GLMA to the AMA House of Delegates. He currently serves as president of the U.S. Professional Association for Transgender Health.
The lack of clinical evidence becomes significant in cardiovascular health and the tools used to prevent heart attack or stroke, because most research on who should be started on statins only had two categories for sex: male and female, Dr. Streed explained.
“That is a disservice for trans individuals because it doesn't take into account their unique experience or their hormone status,” he said.
He added that it also doesn’t serve cisgender women who go through menopause at a younger age. They typically have a higher risk of cardiovascular disease, but “the evidence and the tools built off the evidence don't account for that.”
“We've definitely seen that these same tools don't work well for racial and ethnic marginalized populations,” Dr. Streed said. “They only have three categories of White, Black and other.”
The impact of this incompleteness is that “data remain oblivious” to an accurate accounting of sexual and gender minority populations, Dr. Streed and colleagues wrote in a JAMA Network Open commentary published last summer.
Dr. Streed’s work involves updating research tools to ensure that patient populations that have been left out of research, or whose individual characteristics aren’t found on standard questionnaires, get included and correctly counted in clinical trials and other medical and public health research.
He has provided guidance on clinical trials and public health surveys to the U.S. Department of Health and Human Services, the Food and Drug Administration and the National Academy of Medicine, and has led the development of two American Heart Association scientific statements regarding cardiovascular health and LGBTQ+ patients.
Dr. Streed noted that it was “great” that there are some federally mandated questions in clinical trial surveys to collect demographic data. But, because of the limited boxes available to check, “the quality of that data is not great.”
“We’re not really accounting for people with multiple racial and ethnic identities and backgrounds because people are being forced into one box” said Dr. Streed.
The second cohort of the Medical Justice in Advocacy Fellowship concluded in November. Dr. Streed said the biggest benefit of the fellowship was the peer support provided by his “fellow fellows.”
“We are all experts in different areas in different ways, so we received very helpful and specific feedback to incorporate into our future work,” he explained. “Sometimes we're all stuck in our own little bubble and, as a result, we don't know what other people don't know.”
The most valuable feedback the fellows gave each other were reminders that the work they are doing is important and that promoting health equity isn’t just an esoteric exercise.
“We've all been given—and have given each other—this feedback: We need to stop minimizing ourselves and the work that we do,” Dr. Streed said.