Clinical trials are facing an enrollment crisis. Around 80% of trials don’t meet their enrollment timelines, and fewer than 5% of eligible adult cancer patients participate in trials.
For a phase 3 oncology trial approaching commercialization, each delayed day can cost between $600,000 and $8 million in lost revenue, and slow enrollment is estimated to cost the industry $50 billion per year, according to Vision Lifesciences. Beyond the costs, patient enrollment hurdles mean patients might miss their chance to receive life-saving treatment.
In the grand ballroom of the Boston Sheraton Hotel, biopharma professionals from around the world gathered to discuss the latest trends, technology and opportunities to improve what is a major chokepoint in the drug development world: improving the clinical trial.
The problem has many causes, but a major factor is capacity. “There's a desire to see more trials happen here in the U.S. from many different entities, and we're already at capacity with some of these sites,” said Kendra Orjada, senior director of clinical research policy at Merck & Co., at a senior leadership panel at Fierce’s DPHARM conference this week. “There's a saturation issue. Exactly where are these trials going to go?”
In addition to a shortage of clinical trial sites, recruiting participants who better reflect the patient pool is another challenge. “There are marked differences across geographic regions that reflect standards of care, different prior lines of therapy, different clinical characteristics and disease biology, but not all data in a global trial is going to be applicable to the U.S.,” said Tracy Vanderslice, vice president of clinical operations at Gilead Sciences, who was also on the panel. “We need to ensure we have more representative U.S. patients in our clinical trials to ensure that the data is applicable.”
One answer to the question of how to address these issues is to lean into community medicine trial sites and investigators rather than relying on large academic medical centers, according to panelist Denise Sura, associate vice president of patient engagement at Eli Lilly,
The practice goes beyond just setting up a trial in a community or rural clinic and hoping for the best. “We've got a capability where we bring in patients and we ask them questions: Is this meaningful to you? Do you recognize yourself in the inclusion execution criteria?” Sura said. “This is a capability we developed over 12 years ago, started in oncology, and we apply it to the majority of our work today.”
Working with healthcare providers and caregivers, Sura said the effort on the front end is meant to ensure the company can accelerate the patient through the trial.
Despite the recent negative headlines about AI, the leaders said it needs to play a role within electronic health records (EHR) in addressing the clinical trial crisis as well. “A lot of the traditional work that was done at sites was to look for potential patients, especially with these complex protocols and eligibility criteria,” said panelist Millie Shultz, head of Americas global clinical operations at BeOne Medicines. “New features from EHR mining are allowing us to home in on patients to take some of that space for identifying them.”
Despite the promise, Shultz said her company is still using traditional site selection techniques, but is hopeful for change. She said leadership is accustomed to the traditional methods and can be hesitant about community trial sites. “It’s an opportunity for us as leaders within our organization to educate the broader organization on why this model works,” Shultz said.
The panel was moderated by Angela DeLuca, an AstraZeneca vice president and global head of site management and monitoring. DeLuca asked the panelists what can be done to grow the site footprint and move beyond “fragmented solutions.”
Sura said she had a three-point plan to help move the industry forward. The first is optimizing sites to deliver randomized patient volume, and the second is finding a way to conduct more trials in community-based settings. She concluded with a question: “How do we lean into having and creating an environment where a clinical trial is a genuine care option, where this is built into our standard physical procedures on an annual basis, and where this becomes a common topic for individuals to discuss with their physicians?”
Shultz shared some exasperation but was hopeful that the tides were changing. “One of the things that is perhaps a little frustrating for all of us in the audience and on the panel is we've been talking about access and site burden for every conference I've been to since I've been in this industry, and in some ways it feels like we still haven't moved the needle,” she said. “We're all getting to this point now where we understand the criticality of needing to have U.S. patients enrolled, understanding the urgency around that, and coming to the table on both sides to see how do we get that done.”