Introducing ‘BYOP’ clinical trials

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BYOD — “bring your own device” — became a common term in tech circles a decade ago. Now with primary care doctors playing a growing role in clinical trials, the provider of decentralized clinical research software Curebase (San Francisco) aims to popularize the concept of “BYOP” — “bring your own physician.” That is, the company is working to connect patients with local physicians to collect real-world data and execute trials.

In any event, decentralized and hybrid clinical trials continue to gain ground as the pandemic persists. The trend is elevating the role of community-based clinical trials in areas such as oncology.

Additionally, physicians are playing a growing role in spurring clinical trial recruitment, according to a recent survey from Informa Pharma Intelligence and Rare Patient Voice. Almost half (48%) of patients taking part in a clinical trial had first learned of the opportunity from their physician. Among those who had not participated in a clinical trial, 81% said they would be more likely to participate if their physicians informed them of a possibility of enrolling.

Tom Lemberg

“We have multiple clinical trials right now where patients can participate with their own doctor,” said Tom Lemberg, CEO of Curebase.

One of those trials enables expectant mothers across the country to join a clinical trial. Whereas similar studies in the past would have required patients to visit a local academic medical center to participate, the trial enables women to go to their local doctor. “They can go to their own OB-GYN physician for their normal second- and third-trimester visits, and we can collect data at the point of care,” Lemberg said.

Decentralized studies don’t necessarily mean “clinical trials from your couch,” Lemberg said. Enabling doctors outside of academic medical centers to play an integral role in clinical trials is “the next big step to realize the full potential,” he added.

The clinical trials market was worth $44.3 billion in 2020, according to Grand View Research. Decentralized clinical trials make up a growing slice of the market, thanks in large part to the pandemic. “COVID really forced pharmaceutical companies and regulators to invest in this method,” Lemberg said.

One of CureBase’s customers, InBios International Inc., won emergency use authorization for its SCoV-2 Ag Detect rapid SARS-CoV-2 test. The clinical data InBios filed with FDA was based on a decentralized clinical trial. That study drew data from COVID-19 drive-through testing and clinic-based sites.

“We turned ordinary healthcare providers into researchers,” Lemberg said. “These were not traditional research sites. They were just COVID testing clinics that we activated to form our research network.”

Although fully decentralized clinical trials are not always feasible, they offer several advantages. In addition to reducing COVID-19 transmission risks, they can also help “achieve greater diversity, access to more patients in different demographic groups, socioeconomic groups, racial groups, etc.,” Lemberg said.