Clinical trials play a crucial role in advancing medical research and developing life-saving treatments. However, a constant challenge has been the underrepresentation of Black Americans in these trials, which can lead to incomplete data and health disparities outcomes. One of the key factors contributing to this issue is implicit bias—the unconscious attitudes or stereotypes that influence decision-making and behavior.
What is implicit bias?
Implicit bias in health care is unconscious prejudices that health care providers hold towards patients, based on characteristics like race, ethnicity, gender, age, or socioeconomic status. These biases can influence medical decisions and patient interactions in ways that can poorly impact their health.
During a recent BDO panel discussion on clinical trial diversity, Dr. Nadine Barrett, Senior Associate Dean at Wake Forest School of Medicine, highlighted the impact of implicit bias on clinical trial recruitment and patient retention in those trials.
"Even when we have studies that are showing these implicit biases exist, and that's qualitative. So that's actually coming from the voices of the people who should be asking. Right? The research team and the frontline recruiters," she stated.
Dr. Barrett referenced a study from University of Alabama at Birmingham, which involved 91 interviews with frontline clinical research teams. The study revealed concerning attitudes, such as the perception that people of color would be too challenging to deal with or would not adhere to the treatment protocol. These implicit biases can lead to conscious or unconscious decisions to exclude certain groups from clinical trials, perpetuating the cycle of underrepresentation.
How to address implicit bias in clinical trials
Sharon Rivera-Sanchez, CEO of Trials of Color, echoed the importance of addressing implicit bias in clinical trial recruitment. "We really have to continue to reach out, continue to be a voice," said Rivera-Sanchez. "And when you say meet a person where they are, what does that mean? What that means to me is an underserved neighborhood," she said, emphasizing the need to meet people where they are and engage with them in culturally appropriate ways.
Implicit biases can manifest in various forms, such as assumptions about patient adherence, mistrust of medical institutions, or lack of interest in research participation. These biases can influence the way researchers and health care providers interact with potential participants, creating barriers to recruitment and retention.
Consider a diversity officer
Dr. Ruemu Birhiray, a practicing oncologist and founder of Indy Hematology Education, proposed a solution to combat implicit bias in clinical trials. "If there was a diversity officer, that's what the diversity officer will do. So we all of us have these great ideas, but there isn't an officer or a person who is in charge of that for any clinical trial on a consistent basis," he said, advocating for the appointment of diversity officers to oversee and ensure equitable representation in clinical trials.
Addressing implicit bias is not just an ethical imperative but also a scientific necessity. As Dr. Nadine Barrett pointed out, "If we want to do rigorous science, rigorous science means diversity in the population that's participating in it. Otherwise, we miss the mark in being fully rigorous in that."
A multi-step process to build diverse clinical trials
To achieve truly representative and inclusive clinical trials, a multi-pronged approach is necessary. This includes:
1. Implicit bias training for researchers, health care providers, and clinical trial staff to raise awareness and mitigate unconscious biases.
2. Diversifying the clinical trial workforce to better reflect the communities being served.
3. Implementing diversity action plans and appointing diversity officers to monitor and ensure equitable recruitment and retention efforts.
4. Engaging with community-based organizations and patient advocacy groups to build trust and facilitate culturally appropriate outreach and education.
5. Adopting flexible trial designs and offering comprehensive support services to address logistical and socioeconomic barriers to participation.
By acknowledging and addressing implicit bias, the clinical research community can take a significant step toward achieving inclusive and equitable trials that accurately represent the diversity of the population. Only then medical knowledge advance and we can develop treatments that benefit all members of society, regardless of their race, ethnicity, or background.