The 2022 ASCO meeting kicked off in the first week in June, inspiring many discussions throughout the following weeks about new and exciting innovations in cancer care and treatment, but two buzzworthy topics included the need for more focus on diversity in cancer clinical trials and how sponsors can use the decentralized model to improve patients access to trials.
HealthLeaders spoke to ASCO Chief Medical Officer Dr. Julie Gralow shortly after the ASCO annual meeting to discuss the value DCTs can bring to oncology research.
According to Gralow, people who work with and around ASCO (including oncologists, clinical trialists, patients, industry, and FDA representatives) would prefer to change the term ‘patient-centered trials’ rather than DCTs, because the No. 1 goal of using DCTs is to focus on patients and adjust the protocol in ways that make trials more pragmatic and easier for patients to comply.
“The basic goal behind any DCT is simple: make it easy for the patient,” Gralow says. “It goes beyond decentralizing.”
CLEARING DOUBT IN DCT
The FDA reported just last year that the use of full or hybrid DCT designs was rare in oncology, because of uncertainty surrounding the effect of remote assessments on data quality and outcomes. Gralow believes that is about to change.
“The big concern is will the quality of the clinic visit, the physical exam, the labs, radiology and everything else, be as good when done remotely,” says Gralow. “That’s why we are collecting data now on the remote trials, so we can identify any problems with them.”
FDA has initiated a study to evaluate trial datasets of remote trials against site trials by requesting NDA/BLA applicants to voluntarily add flags to datasets to delineate between remote assessments and trial site assessments.
CHALLENGES
Another challenge is not all patients may have reliable WiFi to support telemedicine. Also post covid, medical licensure will become a problem as waivers for using telemedicine that were in place during Covid have expired. Now patients must be in the physical state where the trial is happening.
However, the overall value of DCTs to improve patient enrollment and retention of oncology trials outweigh the concerns.
“On our taskforce, the majority of the stakeholders involved believe that the benefits outweigh the challenges, and our next step is to make it easy by coming up with good general practices and identifying what’s safe and what’s not,” Gralow says.
BENEFITS
The FDA research has shown that DCTs bring several benefits including reduced patient and sponsor burden and increased accrual and retention of a more diverse trial population.
“There is also a big equity piece to this,” Gralow says. “All of us are committed to having enrollment in cancer trials be more representative of the cancer patient population of the country – and we know we fall behind in that – but DCT is a way to make it easier to enroll patients, they have less days off work, it really helps manage the logistic pieces to make it easier to enroll for populations that are more vulnerable who don’t have those resources.”
According to a report last year in Journal of the National Cancer Institute, more than half of all cancer patients who are offered a clinical trial will participate, suggesting that the barriers to enrollment are more structural and clinical. For example, patients more than half the patients in the study didn’t have a trial available to them at their institution and nearly 22% were deemed ineligible for an available trial. Therefore, enabling access to trials and broadening eligibility criteria through remote trials can improve patient enrollment.
ASCO is conducting a remote hub and spoke care model in Montana, but it is for cancer care instead of cancer clinical trials, but the trial piece will be added, Gralow says. The Boseman Cancer Center serves as the hub and there is currently one remote site where patients can go for infusions. This is a location with no oncologists but there are health providers who can administer infusions, and this allows cancer patients to get treated closer to home.
Broadening the eligibility criteria in DCTs is another way to increase patient access. While site location can be a hurdle for patients, as can stringent criteria, much of which may not be necessary.
In fact, ASCO and Friends of Cancer Research jointly issued new recommendations to further efforts to broaden eligibility criteria in cancer clinical trials with the goal of making clinical trials more accessible to patients.
“There’s been a lot of work between ASCO and Friends of Cancer Research, along with the FDA, and the National Cancer Institute on the acceptability of loosening eligibility criteria,” Gralow says. “I’ve seen more trials being written with the eligibility being much looser to reflect a more real-world population.”
Barriers go beyond the site location but also include the practices of creating really narrow windows for visits and scans. For example, site visits are often required to be on a particular day plus or minus one day, and often those dates could have more flexibility. “While there’s some things where exact dates are crucial, like the date of an infusion is fairly important and should be a fairly narrow window, but some of the other criteria is not,” Gralow says. “Loosening requirements will help more patients participate and not impact the results of the trial.”
The FDA’s interest in determining if DCT trials are viable is spurring other stakeholders to give serious consideration to DCTs. Its studies have already concluded that DCTs can reduce geographic barriers and minimize financial burden by allowing remote participation.
“Changes in oncology trials are already happening,” Gralow says. “We’ll continue to see changes in the next couple of years, and the process will be more standardized within five years.”
