Contributed Commentary by Jeanie Magdalena Gatewood

November 12, 2021 | Even before COVID-19 forced many research directors at healthcare organizations to pull back on clinical trials, most were concerned that trials they were responsible for could end up with zero-to-low accrual of trial participants.

Consider this, approximately 20% of oncology clinical trials fail due to insufficient enrollment. Meanwhile, lack of accrual causes 39% of all premature trial terminations.

Those figures represent a tragedy on many fronts. For patients and physicians, each termination means a lost opportunity for life-saving treatment. For the healthcare organizations hosting the trial, it means a lot of work with little return. And for trial sponsors, it’s a setback in the approval process, aimed towards bringing new and novel treatments to patients – as well as a financial hit.

What if there was a way for clinics to open only the trials that fit their patient population while avoiding the headaches of zero-to-no accrual studies?

This is no longer a fantasy. Parallel advances in Next Generation Sequencing and artificial intelligence mean cancer researchers can remove the guesswork that has long plagued clinical trials—and be more certain of complete or near-complete accrual before opening a new trial.

A New Standard

About five percent of adults with cancer currently enroll in clinical trials—the figure is closer to 15 percent at academic centers and one percent at community centers. Recent research from Penn State highlighted a specific problem in this pattern of trial enrollment.

Researchers reviewed the records of 12 million cancer patients between 2004 and 2015 and found that just 0.1% were enrolled in clinical trials as their first course of therapy following diagnosis. And yet additional studies have shown that 55% of cancer patients are willing to enroll in clinical trials if offered, not just as a last resort.

Clinical trials must be part of the first conversation oncologists have with patients upon referral. This is when patients are relatively healthier than later in the progression of a disease and have experienced less pretreatment, so may be most likely to qualify and reap the benefits of trial enrollment.

Yet, oftentimes, trials continue to be viewed as a last resort. Of course, some patients won’t match inclusion criteria. But patients deserve to understand the promise of clinical trials in 2021 – now that it is possible to identify the genetic makeup of a specific patient's cancer and match these with a molecule specifically developed to target that tumor. The sooner that tumor is attacked, the more likely it is doctors have an opportunity to slow or stop it.

Next Generation Sequencing is at the center of this conversation. Clinics can and should be uploading genetic sequencing from new patients to find potential trial matches.

In the past, screening every new patient for potential trial matches would have been prohibitively time-consuming — for physicians, research directors and their staff. That’s why smart platforms potentially powered by artificial intelligence can be an essential piece of the equation for modern cancer care. In terms of AI, the most effective tools can parse unstructured data and produce a very narrow but precise yield of patients matched to specific studies with a high level of certainty.

Conducting Trials With Confidence

As cancer centers make trials part of their onboarding for new patient referrals, they position themselves to be confident and consistent trial hosts as well.

Using an AI-powered platform, clinics can have a searchable database of the DNA sequencing of their patient population, right at their fingertips. Further, they have the power to conduct continual reviews to identify matches for upcoming or ongoing trials.

Rather than making an educated guess about what trials might work and then inviting trial investigators to do the screening, centers can deploy study feasibility technology to do that work, with confidence, upfront — so that they know exactly how many patients are a genetic match before committing to conduct a trial.

The most important benefit of this transformation is expanded patient access to cutting-edge cancer treatments, at an earlier stage in their disease process possibly halting progression of disease. The knock-on effects can result in a far more efficient and effective cancer treatment ecosystem.

Cancer centers can avoid the reputational damage of failed trials — and can proceed knowing that the administrative burden will not go unreimbursed. Sponsors will move therapies to market faster and spend less time and money on low-accrual trials.

Ultimately, this cycle of collaboration between clinics and sponsors will break down the barriers that prevent so many cancer patients from accessing emerging medicine. We are closer to taking the guess work and game of chance out of the clinical trial process for cancer centers, delivering on the promise of precision medicine in oncology and that much closer to all of the benefits that can be unlocked as we succeed in selecting appropriate studies that match and meet the needs of our cancer population.

Jeanie Magdalena Gatewood is Vice President of Cancer Center Support Services for Inteliquet, a clinical trial patient matching software company. Prior to joining Inteliquet, Jeanie served as Vice President of Research Strategy at Temple University Healthcare System: Fox Chase Comprehensive Cancer Center. She can be reached at jgatewood@inteliquet.com.