Increasing diversity in clinical trials: What can doctors, regulators, and patients do?
Written by Yella Hewings-Martin, Ph.D. on July 10, 2020
Most clinical trials do not score highly on the diversity front. In this Special Feature, we explore who takes part in clinical trials, what barriers prevent others from doing so, and what patients, doctors, and those involved in drug approvals can do to improve on this.
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Many diseases lack effective treatments, and many researchers worldwide are trying to address these unmet needs.
Clinical trials form the cornerstone of new drug approvals, and without the volunteers who participate in clinical trials, this process would not be possible.
Yet, clinical trials overwhelmingly fail to represent the demographic diversity of the populations that the drugs in development aim to serve.
Black and Hispanic patients ‘consistently underrepresented’ in trials
A 2019 article in JAMA Oncology highlights disparities in race reporting and diversity in clinical trials in the cancer field.
Along with their colleagues, Dr. Jonathan Loree, a medical oncologist and assistant professor at the University of British Columbia in Vancouver in Canada and Dr. Kanwal Raghav, an associate professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston analyzed 230 oncology clinical trials. These trials took place between 2008–2018 and resulted in the Food and Drug Administration (FDA) approving cancer drugs.
They found that only 145 (63%) of the 230 trials, included any information about the participant’s race.
More specifically, only 18 trials (7.8%) gave a breakdown of the participants by the “four major races in the United States (white, Asian, Black, and Hispanic)” as the authors put it.
On average, 76.3% of the participants were white, 18.3% Black, 3.1% Asian, and 6.1% Hispanic. In the period that the authors looked at, these percentages changed only marginally.
From July 2013 onwards, the proportion of Hispanic trial participants increased slightly, while the proportion of Black participants fell slightly.
“Black and Hispanic patients were consistently underrepresented compared with their expected proportion based on cancer incidence and mortality in the United States, whereas Asian patients appeared to be overrepresented, and white patients had enrollment that nearly matched their expected proportion,” the authors write.
A 2018 Comment in Nature echoes these findings. Here, the authors collated data on trials that led to FDA approvals between 1994 and 2014.
“The median percentage of African and African American participants per trial ranged from 1.8–3.5%. For Asian participants, the range was 0–7%, and for any group unspecified or not described as white, Black or Asian, it was 1.4–3.4%,” the authors write.