Cancer Trials Increasingly Using DCT Methods, Finding Solutions Despite Hurdles
Decentralized trial (DCT) approaches are often overlooked in oncology due to cancer research’s more stringent drug requirements and complex assessments, but experts say that, when deployed correctly, many DCT approaches can help break down barriers cancer trials have faced.
“Oncology studies are not amenable to a fully decentralized clinical trial due to the nature of the investigational medicinal products and assessments,” says Ada Middleton, senior director of Parexel’s Patient Innovation Center, but a hybrid approach is possible, with the majority of visits still occurring at a site and some support tasks handled remotely.
One of the greatest benefits of DCT methods is the potential to increase pools of prospective study participants, which is especially relevant in oncology, a therapeutic area that often deals with small patient populations. In addition, DCT approaches can help remove geographic and socioeconomic barriers and increase trial access for underrepresented groups.
This pairs well with ongoing emphasis on patient-centric studies, where trial participants’ needs and capabilities are considered from the earliest phases of study design. In particular, the number of visits and distance traveled to sites are common complaints among participants.
Burdensome treatments and side effects are compounded by the need to travel to a research site, says Archana Sah, senior vice president of digital and decentralized solutions at Medable. This can result in lack of participation in clinical trials, as well as participants dropping out mid-study, Sah told CenterWatch Weekly. Enrollment challenges and lack of patient diversity also tend to plague oncology trials. Other challenges include:
- Adverse events that can be missed when sites don’t have access to real-time participant-reported data;
- Investigational drug and concomitant medication dosing delays that impact trials’ ability to manage the safety and tolerability of treatments; and
- Low participant retention during long-term follow-up periods that can result in loss of needed survival and safety data.
While investigational cancer drugs and/or comparators often need to be administered at the site due to the nature of the treatments, some may be safe to administer in the home, especially in later cycles, according to Middleton. Imaging and most screening assessments must occur on site, she acknowledges. And complex lab samples — such as those taken in cell studies, for instance — are also not amenable to home collection.
But some follow-up visits have the potential to be carried out remotely or at a participant’s home, Middleton says, potentially cutting down on participant burden. For instance:
- Home nurses can obtain and process blood/biologic samples and perform assessments;
- Telehealth visits can allow patients to evaluate adverse events with the principal investigator between site visits; and
- An app can be used for participant education, patient-reported outcomes, and visit scheduling and reminders.
Looking at the issue from a fit-for-purpose angle, some trials and observational or registry studies may be suitable for a fully decentralized approach, Sah said, such as early screening of cancer studies via tests shipped to patients’ homes. It’s important, however, to note the critical connection between cancer participants and investigators; diminishing that could negatively impact retention.
“The patient-investigator relationship is often key to cancer clinical trial participation,” she added. “And a hybrid approach is best suited to provide this to the patients.”
Despite the inherent hurdles for using DCT approaches in cancer research, sponsors and CROs appear to be shifting toward more hybrid designs, and Middleton believes that industry can expect to see a steady increase in hybrid oncology trials. According to DCT specialist Science 37’s survey taken late last year, 46 percent of respondents said they intended to conduct an oncology trial with at least some DCT elements in 2022, an increase of 11 percent from the year prior. And in general, the survey indicated that sponsors and CROs plan to run more hybrid trials compared to traditional trials in the coming years.
Decentralized approaches would need to be considered during study concept and protocol development phases, Sah said, with careful consideration given to the assessments necessary to meet study objectives. Sponsors might also consider planning the study schedule for group assessments and procedures in a way that cuts down on the number of on-site visits, as well as brainstorm how some visits could be done effectively using remote approaches.
Common tasks that could be decentralized include consenting, routine labs and vitals measurements, and medication pick-ups. And some DCT tools, such as electronic informed consent, telehealth visits, wearable sensors and direct-to-patient shipment of oral investigational drugs and concomitant medications, can move cancer trials toward a more hybrid model that increases participant satisfaction and engagement with the trial.
Sah noted that Medable, for example, has deployed these techniques in studies of treatments for solid cancers and hematologic malignancies from phase 1 through 4, while Middleton suggested that later-phase oncology studies may be more conducive to a decentralized approach than early-phase studies in which patients are often relapsing and require in-clinic treatments.
“When considering study strategy, it isn’t about making visits remote versus onsite. It is about providing participants with options,” Middleton added.