The COVID-19 pandemic has elevated the importance of clinical trial diversity while also asserting remote clinical trials as a valid approach for a growing number of drug studies, as a recent JAMA study concluded.
At the same time, the pandemic highlighted the need for continued progress, according to Otis Johnson, chief diversity, inclusion and sustainability officer at Clario.
“I think COVID shone too much of a bright light on the lack of diversity in clinical trials for us not to make progress,” Johnson said.
More regulatory clarity
While a growing number of drug developers are prioritizing diversity, “regulatory agencies will need to be more deliberate,” Johnson added. “So far, the guidance has been exactly that — guidance.” Regulatory agencies should mandate best practices supporting diversity in clinical trials, he said.
The lack of diversity historically is startling. “If you look at the 371 drugs that were approved by the FDA, between 2007 and 2017, only 37% of the clinical trials that supported those submissions had ethnicity data.”
When the lack of diversity is dangerous
The lack of diversity has real-world implications. “You could have a loved one taking an approved medication for a life-threatening condition, but you’re not sure if it’s going to work because it wasn’t tested in enough people like you,” Johnson said. “That’s just a dangerous proposition.”
At the same time, it can be challenging to persuade diverse populations to participate in clinical trials, given the precedent of unethical experiments on minorities that ultimately led to the formation of the U.S. Office for Human Research Protections around the turn of the century.
“There have been some significant events in the past that have eroded that trust, and we really need to rebuild that,” Johnson said.
COVID-19 drug trials could point to the future
The majority of clinical trials for COVID-19 vaccines and drugs were more diverse than is typical in the industry.
It was only fitting because, in the early days of the pandemic, in particular, diverse populations were disproportionately affected. “Blacks were three times more likely to contract COVID and were two times more likely to die from it,” Johnson said. “Naturally, the vaccine developers had to make sure that they had adequate representation of minorities in those trials to make sure that the vaccines work for all.”
The pandemic underscored the potential of decentralized trials to help foster diversity and be more patient-friendly. “We need to make the whole trial process as easy for participants as possible and recognize that diversity in clinical trials is the only way to ensure that the medicines that we develop are safe and effective for all,” Johnson said.
In addition, in-person trials can present obstacles to diversity. “If there’s unequal access to transportation and parking — basic things like that, it would make it difficult for a diverse patient to participate in a trial.”
How technology and a diverse workforce can help with clinical trial diversity
Johnson underscores the importance of clinical trial organizations having a diverse workforce. “We know if your workforce is diverse, you’re more likely to get patients to sign up for your clinical trials,” he said.
At the same time, the growing use of technology in clinical trials is “the great equalizer,” Johnson said. It has never been easier to implement telehealth or diverse clinical trials. “If technology is used right, it’s a game-changer for facilitating clinical trial diversity, but also enabling health equity overall.”
“It’s never been a more exciting time to work on this problem of patient diversity,” Johnson concluded.
Filed Under: clinical trials, Drug Discovery