Community-based clinical trials are growing more common in oncology for several reasons.
First, drug developers are looking to boost recruitment efforts and address traditional ethnic and economic health disparities in such studies. Second, community hospitals are growing better equipped to participate in such trials. And finally, drug developers are working on expanding the pool of patients they can recruit in such studies.
Traditionally, community cancer centers have sat on the sidelines in terms of clinical trials. Notable academic medical centers such as Massachusetts General Hospital, Dana-Farber Cancer Institute, Memorial Sloan Kettering and MD Anderson have played a vital role in oncology clinical trials. But the situation is beginning to change for the following reason.
Community hospitals can help address health disparities
Many pharmaceutical and healthcare organizations are making a concerted effort to improve the equity of clinical trials, which have traditionally plagued clinical trials.
For instance, Abramson Cancer Center at the University of Pennsylvania doubled the percentage of Black participants in its oncology trials (from 12% to 24%) through a five-year community outreach program.
While Blacks make up 13.4% of the U.S. population, only 4% of oncology clinical trial participants in the country are of that ethnicity, according to FDA’s 2019 Drug Trials Snapshots Summary Report.
Recruiting from community hospitals for oncology trials can help address racial and economic health disparities because academic centers have traditionally had an overrepresentation of certain demographics, said Jeff Elton, CEO of ConcertAI (Boston). Traditionally, clinical trial participants from academic medical centers “tend to have a higher net worth,” Elton said. “The average age was a little younger. And they didn’t really look like what the whole population in the country looks like.”
Pushing a growing number of clinical trials to community centers increases the likelihood of drug developers reaching, say, people with certain cancers that have a disproportionate impact on minorities. “I have a higher likelihood that I can actually accrue to targeted participation rates of different groups that need to be impacted by that disease state,” Elton said.
Community hospitals are growing more tech-savvy.
Traditionally, academic medical centers have had several advantages over community facilities in terms of clinical trials. Such academic centers tend to have more clinical personnel per patient and infrastructure such as next-generation sequencing. They also have been more likely to benefit from funding from organizations such as the National Cancer Institute.
“The economics looks so different” for academic medical centers, and “the technologies were unlike what a normal provider could afford to have in place,” Elton said.
But now, technologies such as next-generation sequencing are beginning to become more common in community settings, thanks to expanding reimbursement from CMS.
As community hospitals become more familiar with such technologies, they become more desirable partners for clinical trials.
Community hospitals are more convenient for many patients.
More than 80% of cancer patients rely on community oncology settings for treatment. As oncology drug developers look to expand the pool of patients for oncology clinical trials, such centers are a natural place to look.
“Sponsors need to find new locations to grow who participate in trials,” Elton said. “They want to expand to take sites that historically did small amounts of research.”
Such community centers are also more convenient for many patients. “Most people want to go to a facility near home,” Elton said.
There’s also a financial upside for community centers to expand into clinical trials.
The pandemic put downward pressure on hospitals’ profit margins, as have price caps on oncology drugs. “It’s a tough business,” Elton said.
Community hospitals that can increase their involvement in research can help provide “economic sustainability to some of those community practices,” Elton added.
Drug developers have a vested interest in expanding the number of clinical trial partners. “I think you’re gonna find sponsors working super hard at being flexible — even helping build capacity and capability in these community-based oncology centers,” Elton said.
Filed Under: clinical trials, Drug Discovery, Oncology