Stacey Bledsoe joined Gilead Sciences in 2022 to serve as the biopharmaceutical company’s first Head of Global Clinical Trial Diversity and Inclusion. As a registered nurse with more than two decades of experience in the pharmaceutical industry, she saw a unique opportunity to fulfill a personal and professional obligation to improve representation in clinical studies that evaluate the safety and efficacy of new medications and protocols.
“My father was diagnosed with lung cancer in 2016,” Bledsoe explains.
“I asked his caregivers whether any trials were open to him and was told there were none. That didn’t sit well with me. I started thinking about Black people’s experiences and what we in the healthcare industry were doing in this space. Didn’t we have a responsibility to ensure everyone has access to innovative drugs and treatments that can save lives?”
Black people have been largely left out of clinical research due to centuries of past and present systemic medical mistreatment, directly leading to community distrust of the healthcare system. Another fundamental barrier has been the industry itself.
“Historically, clinical trials in the United States have almost exclusively focused on middle-aged white males,” Bledsoe told BLACK ENTERPRISE.
“The industry didn’t start focusing on women at all until 1993 – Black women and minorities followed that.” The result is that decades of established treatment protocols—many of which are currently standard use—are based on data culled from a single, narrow patient demographic.
Bledsoe points to FDA data finding 20%
of drugs approved for use in the U.S. produce different reactions in patients based on the individual’s race or ethnicity.“If we aren’t part of clinical trials, then we don’t have this information until after these drugs go on the market,” she says, noting that differences in gender, age, family history, as well as socio-economic determinants, all factor into the risk/benefit equation when evaluating a course of treatment.
Bledsoe believes the critical lack of data is at least partially responsible for shocking health disparities and poor disease outcomes among African Americans.
“Black women are 41% more likely to die of breast cancer than our white counterparts, yet we account for only 10-15% percent of participants in clinical trials for cancer treatments. Diversifying clinical trials will help us better understand how different treatments affect the populations that can benefit most,” Bledsoe shared.
“Representation in clinical trials not only matters, it saves lives,”
Amid National Minority Health Month, Bledsoe took the opportunity to discuss the necessity of Black participation in clinical trials and Gilead’s efforts to eliminate the barriers that have manifested both in the community and the healthcare industry.
She explains: “We are focused on a strategy with three main components: patients, providers, and partners.” Specifically, the company is conducting community outreach to educate patients about the importance of clinical trials and empower them to advocate for participation with their doctors. On the provider front, Gilead challenges the misconception that communities of color are “hard to reach.”
The goal is to locate clinical trial sites accessible to people of color and where trial investigators are racially diverse. The final piece of the puzzle is partnerships.
“We know we can’t do this work alone. Gilead enters partnerships and collaborations with trusted intermediaries in the community that address diversity in clinical trials and help equity as a whole.”
For example, Bledsoe cited Gilead’s recent Black History Month collaboration with Black Health Matters, a nonprofit which kicked off an educational campaign raising awareness of Gilead’s clinical trials for triple-negative breast cancer. The company also partnered with Highland Hospital in Oakland, California, to support a new cancer clinical trial center to make cancer care accessible to the area’s predominantly Black community.
On the policy front, Gilead is working toward implementing new guidance from the FDA that will require biopharmaceutical companies to enroll more participants from underrepresented populations into clinical trials.
While Gilead, energized by Bledsoe’s drive and leadership, is making strides in diversifying clinical research, change is also coming across the industry. Pharmaceutical companies were spurred to act on this front by the healthcare inequities exposed by the COVID-19 pandemic and the federal government’s subsequent demand for increased accountability from the industry.
“These events started the fire,” Bledsoe told BE.
“New FDA guidelines require companies to have a diversity plan for every Phase 3 clinical study, and in that plan, you must have enrollment goals for recruiting diverse patients.”
Bledsoe feels her efforts at Gilead have the advantage of the company’s supportive leadership and a larger culture that values diversity. As part of growing that culture and creating a healthier world for all people, the company is also actively involved at the community level. Gilead is on–the–ground investing in education, partnerships, and innovative sciences so that historically marginalized and disinvested communities have fair and just opportunities to achieve their best health.
Bledsoe explained, “I came to Gilead because of its history of putting the patient first. The company has achieved this with HIV, with hepatitis, and that level of support continues with oncology. At Gilead, we are committed to increasing diversity in clinical trials and advancing global health and Black equity overall.”
The bottom line is that science is better when everyone has a seat at the table, and improving the diversity of clinical trials requires enabling communities to contribute to the research and development process.
For assistance in finding a clinical trial, Gilead has created an easy-to-use search tool, which can be found here.
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