Conner, now 65, of Jenkintown, said she didn’t know much about breast cancer and didn’t know anyone who had it. She is grateful that her doctor suggested a clinical trial.
“We don’t talk about it in our community,” said Conner, who is Black.
Early in the pandemic, the U.S. Food and Drug Administration gave ongoing trials the green light to allow remote participation when possible — a protocol change that typically requires extensive review.
Rutgers went a step further by making its new COVID-19 clinical trials entirely remote. The approach drew a more diverse patient population — 30% of participants were people of color — and enabled researchers to draw from a broader geographic area and fill spots more quickly, because it was so much easier to participate, Panettieri said.
“It’s sort of always been done at the convenience of the investigator, rather than the patient,” he said of trials.
The decentralized trials developed out of necessity during the pandemic could lead to a new standard for hybrid trials that include in-person and remote participation, Esther Krofah, executive director of the Center for Public Health at the Milken Institute, wrote last summer in Health Affairs.
“This year was a time for reflection on changes made to the clinical trials enterprise in response to the COVID-19 pandemic and for more purposefully considering how the system ought to be redesigned,” Krofah wrote in an article coauthored by other former pharmaceutical executives.
Clinical trials often call for participants who do not have other health issues that could influence how well the treatment works, or whose illness has not advanced to a late stage. This can exclude people of color, who are more likely to have multiple chronic conditions.
And doctors are less likely to recommend clinical trials to Black and Latino patients, whom they assume won’t be eligible, Guerra found in research to be published in June in the Journal of Clinical Oncology.
“These unconscious biases are really underestimating the fact that individuals would want to participate if they were offered,” she said.