Oncology: Surprising Therapeutic Area Ripe for Decentralized Research
Candice Del Rio
Curavit Clinical Research

iven the complexity of cancer, some researchers are skeptical about the use of a decentralized clinical trial (DCT) model for oncology research. However, DCTs offer tremendous benefit, particularly in decreasing patient dropout rates and increasing patient engagement, two critical factors for oncology.

Oncology represents the largest research area globally, with 6.5% annual growth from 2000 to 2020 compared to 3.6% for nononcology drugs in development. At the same time, oncology trials face unique challenges including patient enrollment and retention problems, complex trial designs across more sites, larger data sets, longer durations, and more protocol deviations (to name only a few). In fact, the three phases of oncology trials last almost 12 years, on average, compared to 8 years for nononcology trials. And oncology trials generate a much higher volume of data: 3.1 million data points per protocol in phase 2 oncology compared with 1.9 million in nononcology.

It’s no surprise that, as of June 2021, only 5% of the 4,576 trials utilizing DCT strategies are oncology studies. Various explanations for this lag may include the type of investigational product, the need for invasive tests and scans, and the uncertainty surrounding the effect of remote assessments on data quality. However, a well-designed DCT that considers regulatory and operational concerns can not only overcome these issues but also improve research performance, data quality, and speed.

Wrong Assumption: Cancer Trial Patients Prefer In-Person Visits

Many cancer patients would prefer to stay home. For instance, patients diagnosed with acute myeloid leukemia—a cancer of the blood and bone marrow that progresses rapidly—juggle many physical and psychological side effects from the time they receive initial treatment through their post-hospitalization course. Prolonged symptom management, often involving nausea and fatigue, makes outpatient visits particularly challenging. Follow-up oncologist appointments are already time-consuming and may include blood transfusions, intravenous medication delivery, and comorbidity management. Tacking on additional research assessments before patients can go home may be more than they can bear.

DCT technologies enable remote monitoring so ailing cancer patients can remain in the comfort of their homes and reduce the burden of in-person visits, in turn, attracting more trial participants. Continuous remote monitoring provides the added benefit of better real-world data.

Pete, a middle-aged survivor of acute lymphoblastic leukemia, endured an arduous, three-year chemotherapy course. Three months into his treatment, he entered a clinical trial using blinatumomab, which was taken in parallel with his chemotherapy. Within just one month, his leukemia disappeared completely, but due to risk of recurrence, Pete underwent three more cycles of trial drug. Today, he sees considerable value in a DCT approach during the maintenance and monitoring phases, which will last for the next three years.

“I do televisits with my oncologist now, which is much easier,” said Pete in an interview for this article. “You can’t replace in-person visits in the early stages of a trial, but virtual technologies can ease the burden long-term.”

Modern Technology Delivers Better Data

Decentralized methods can provide more granular longitudinal data than conventional trials, especially where time-sensitive results need to be tracked. A typical conventional oncology trial, noted Ingrid Oakley-Girvan, PhD, SVP of research and strategy at Medable, involves patients coming to the clinic for regular infusions and completing a questionnaire on how they have been feeling over a specific period. The DCT approach, however, leverages mobile devices to measure symptoms more frequently, even continuously, and in real time to provide better insight into quality of life.

“Traditionally, trials have used a blunt methodology to assess symptoms, but we can now include remote real-time data capture for out-of-clinic insight on symptom development in direct correlation to treatment timing,” explained Oakley-Girvan.

Medable supports oncology research through participation in the National Cancer Institute’s (NCI) Cancer Moonshot initiative. Its Digital Biomarkers for Care study identifies which endpoints best reflect quality of life while predicting disease and providing symptom alerts within specific populations. The study uses DCT technologies for passive, continuously measured, and analyzed data streams bolstered by connected wearable sensors to be used outside the clinic. In the 28-day study, patients and caregivers reported that the remote data capture method was “very helpful.”

Elizabeth Abraham, RN, BSN, is a senior clinical research nurse specializing in breast oncology at Mass General Cancer Center. According to Abraham, virtual screening can be performed using patient records and video consultations before patients come in for necessary in-person tests. Consent can also be obtained virtually, reducing burden on trial participants during a time when they feel the worst.

Once a patient is enrolled, using local labs for follow-up can reduce travel time. The drug is shipped out by express courier directly to the patient’s home and, depending on the trial, a diary accompanies the shipment for patient-reported responses.

“Patients appreciate that they don’t have to travel,” says Abraham. “If they have any complications, then they need to come in and be seen. But otherwise, when they are stable, we can proceed with the next cycle of treatment from the convenience of their homes. I have one patient who recently came in with all her drug diaries and study drug bottles, but she was able to stay home for almost two years!”

Learning from COVID-19

Given oncology’s complexities, skepticism of DCT use is understandable. But the benefits are increasingly clear. And as the industry continues to incorporate lessons learned from the COVID-19 pandemic, improvements in patient retention, data, and outcomes may change mindsets. A new study shows that 46% of sponsors/CROs expect to run a decentralized oncology study in the next year vs. 35% during the previous year, making oncology the most prevalent DCT category.

Let’s not turn the clock back and ignore what we’ve learned. Instead, let’s continue making improvements in clinical research and oncology outcomes by applying proven, modern technologies.