Building trust, community engagement key to improving diversity in clinical trials
Goals for organizations aiming to foster community engagement include commitment to building trust and encouraging clinical trial participation among underrepresented groups, a speaker said.
“What is the goal of community engagement?” Melissa Bishop-Murphy, JD, MBA, the senior director of national government relations and multicultural affairs for Pfizer, asked attendees during the virtual meeting of the 2022 Association of Women in Rheumatology annual conference. “Frankly, it’s to build trust, because patients or potential persons who are going to participate in a clinical trial are not going to participate in that clinical if they do not trust the people who are administering the trial, the person who is asking them to participate in that trial.”
Bishop-Murphy added, “So it is very important that we build trust and encourage participation among underrepresented groups.”
She pointed to Pfizer’s Multicultural Health Equity Collective, which has been working to achieve health equity since before the COVID-19 pandemic.
“COVID-19, really was, frankly, the eye-opener for the world, that there were health care disparities,” Bishop-Murphy said. The disproportionate impact of the pandemic on underserved communities illustrates the importance of reducing health care disparities, she added. “Pfizer was already well-prepared when COVID happened, because we had already established trust with community-based organizations.
“For Pfizer, it was critical as we were developing the vaccine, that our clinical trials were reflective of the population that was most impacted by COVID-19,” Bishop-Murphy said.
The result, she said, was a collaboration between the Multicultural Health Equity Collective and Pfizer’s global product development team, to partner with underserved communities in and raise awareness of the COVID-19 vaccine clinical trials.
One barrier to achieving proper representation in clinical trials, Bishop-Murphy said, is the current lack of demographic data collection in clinical trials. Citing a 2021 study by Flores and colleagues, she said that “only 58% of all vaccine trials, across all trial phases, reported race, and 34% reported ethnicity.” Additionally, she noted that 1% of all registered cancer trials are “primarily directed toward racial and ethnic minorities,” and only 33% of cancer trials report data on the race and ethnicity of participants.
As a result of the lack of data in clinical trials, Bishop-Murphy said, the FDA has implemented new guidelines intended to support the diversification of clinical trials. Diversity plans will play an important role in the future of drug development programs, Bishop-Murphy said. The plan requires companies to submit an application disclosing diversity data.
“I really believe this is really great news,” Bishop-Murphy said. “This is still draft guidance, but certainly companies like Pfizer are already working on preparing diversity plans when we do our investigational drug.”
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Bishop-Murphy M. Diversity in clinical trials: Building bridges through community engagement. Presented at: Association of Women in Rheumatology annual conference; Aug. 18-21, 2022 (virtual meeting).