Photo by Steve A Johnson

In honor of LGBTQ+ History Month, we’re recognizing the activists who changed clinical research and what our industry still owes the community today.

For much of our industry’s history, clinical trial participants were predominantly white men. Women, people of color, and the LGBTQ+ community have often been underrepresented, and in some cases excluded by policy. But they didn’t accept being shut out.

October is LGBTQ+ History Month, and part of that history is a set of clinical research reforms that LGBTQ+ activists, together with women and communities of color, helped win. Some of the most important changes in how trials run today came from that fight, and they now benefit patients everywhere.

The cracks in the system and how they were revealed

In 1981, the CDC published its first report of what became known as AIDS. Early on, the disease was mislabeled GRID, or “gay-related immune deficiency,” a name that contributed to a false and dangerous assumption that this was only a disease impacting gay and bisexual men. It wasn’t. AIDS also devastated women, particularly women of color, and many of them weren’t counted. Women who were dying often went undiagnosed, unable to qualify for benefits or join the research that might have extended their lives.

While research for AIDS treatment was underway, it was moving far too slowly. At the time, getting a new drug approved could take the better part of a decade. For people with a fast-moving illness, that approval timeline was a death sentence.

What the activists fought to change

In March of 1987, activists in New York founded ACT UP (the AIDS Coalition to Unleash Power). Through direct action, like a 1988 protest at FDA headquarters that ended in about 175 arrests, ACT UP and the movements around it fought on many fronts at once:

• Faster drug approvals
• Access to experimental treatments for people too sick to wait
• An AIDS definition that counted women
• Trial designs that didn’t ask dying people to take placebos
• A real voice for patients in how research was run

Not every fight was won quickly, but many of the changes activists fought for are now so standard that it’s easy to forget someone had to win them. This is what they helped change:

Faster paths to treatment. In the years after ACT UP’s protests, the FDA created its accelerated approval pathway, and the FDA and NIH launched expanded access through Parallel Track, which let patients with no other options receive promising experimental drugs that were still being tested in clinical trials. Today, accelerated approval helps bring therapies for cancer, rare disease, and more to patients sooner.

Women counted, and included. ACT UP’s Women’s Caucus, co-founded by Maxine Wolfe (who also co-founded the Lesbian Avengers), and lawyer Terry McGovern, whose HIV Law Project took the fight to court, pushed the CDC to expand its AIDS definition to reflect how the disease showed up in women, a change it finally made in 1993. That same year, the FDA withdrew its 1977 restriction on women of childbearing potential in early-phase trials, and the NIH Revitalization Act required NIH-funded research to include women and racial and ethnic minorities.

Patients as partners. Activists didn’t just want faster access to treatment. They also wanted a say in how those drugs were tested. They questioned eligibility rules that shut out women and people of color and demanded seats at the table. By 1990, the NIH’s AIDS Clinical Trials Group had formed a Community Constituency Group, and activists and people with HIV went on to win voting seats on its research committees.

The parallel fight led by communities of color

Communities of color, often shut out of mainstream AIDS spaces, built their own organizations and pushed for change from within existing ones. Many of these organizations are still fighting for health equity today:

• In 1986, an American Public Health Association panel on AIDS included no people of color. Craig Harris, a Black gay man living with HIV, rushed the stage and announced the formation of the National Minority AIDS Council, founded in 1987.
• Dázon Dixon Diallo founded SisterLove in Atlanta, the first southeastern U.S. organization focused on women living with and at risk of HIV.
• In San Francisco, members of the Gay Asian Pacific Alliance’s HIV/AIDS committee started the GAPA Community HIV Project in 1989, one of the first organizations in the country to offer culturally appropriate services for Asians and Pacific Islanders living with HIV.
• In Minnesota, Sharon Day, an Ojibwe activist, helped found the Minnesota American Indian AIDS Task Force in 1987 to provide culturally appropriate HIV education and services to Native communities. It is now the Indigenous Peoples Task Force.
• Ortez Alderson helped found ACT UP’s Majority Action Committee, which pushed ACT UP to focus on issues affecting people of color.
• In 1990, a coalition of Latino leaders founded the Latino Commission on AIDS.

The work isn’t finished

Despite decades of hard-won progress, there are still gaps to fill. In a 2024 PAN Foundation survey, 65% of LGBTQ+ adults said they were interested in joining a clinical trial, yet only 20% said a healthcare provider had ever discussed one with them. The willingness to participate is there, but the invitation too often isn’t.

On top of that, sexual orientation and gender identity (SOGI) data are rarely reported in clinical trials, so we often can’t tell whether LGBTQ+ people are being included. A Parexel analysis of more than 141,000 published articles reporting trial results from 2018 to 2022 found that fewer than 1% reported participation of transgender and nonbinary patients. And in 2025, NIH terminated hundreds of millions of dollars in research grants, including studies focused on LGBTQ+ health.

Money is a barrier, too. LGBTQ+ adults are about twice as likely as other adults to rely on Medicaid as their primary insurance, and today a trial payment counted as income can put Medicaid or SNAP eligibility at risk. That’s one reason Mural Health champions the bipartisan Harley Jacobsen Clinical Trial Participant Income Exemption Act, which would exclude trial payments from taxable income and protect the benefits participants depend on.

How we can carry progress forward

As LGBTQ+ History Month comes to a close, we encourage everyone in clinical research to keep learning about this history and to consider how we carry the legacy forward. There are concrete steps we can all take:

• Equip providers and sites to talk with LGBTQ+ patients about clinical trials
• Collect SOGI data thoughtfully and with privacy in mind
• Build trials where every participant feels respected and seen

The activists of the 1980s and ’90s proved that the people most affected by research belong at the center of it. It’s on all of us, sponsors, sites, providers, and partners like Mural Health, to act on it.