Oncology represents the largest research area globally, with 6.5% annual growth in the number of oncology drugs from 2000 to 2020 compared to 3.6% for non-oncology drugs in development.¹ At the same time, oncology trials face unique challenges, including patient enrollment and retention problems, complex trial designs, larger data collection activity, longer durations, higher volumes of protocol deviations, and more substantial amendments.

Furthermore, the prevalence of cancer and morbidity illustrate disparities across ethnic groups and, therefore, a need for greater patient diversity in oncology trials. Decentralized clinical trials (DCTs) and new digital solutions in the oncology space can address these challenges. Yet, there still appears to be hesitancy across the industry in utilizing digital and decentralized elements in oncology research.

In June 2021, a search of GlobalData’s recently launched “decentralized/virtual trial” database revealed only approximately 5% of the 4,576 trials utilizing DCT strategies are oncology studies. Various explanations for this 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, many of these hurdles can be overcome through an appropriate and well-designed DCT that considers regulatory and operational concerns.

It’s time to bust the myth that DCTs are not right for oncology. DCTs are showing great promise in oncology research, especially as a solution to decreasing patient dropout rates and increasing patient engagement, two critical factors for oncology. With the rise of immuno-oncology and precision medicine, the patient pools continue to get smaller so drop-out rates – and the resulting data bias – make or break a cancer clinical trial. DCTs are inherently patient-centric, which means patients are more likely to stick with them as they accommodate their financial needs and lifestyle.

One prevailing myth is that oncology patients want solely in-person attention during trial participation. However, these patients experience tremendous treatment burden and often don’t feel well enough to come in for frequent, lengthy office visits during certain stages of their disease.

For instance, patients diagnosed with Acute Myeloid Leukemia – a cancer of the blood and bone marrow that progresses rapidly – juggle 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, make outpatient visits particularly challenging. Follow-up oncologist appointments are already time-consuming and may include blood transfusions, intravenous medication delivery, and co-morbidity management. Tacking on additional research assessments before patients can go home may be more than they can bear. Virtual technologies enable remote, continuous monitoring when patients are in the comfort of their own home. This is also true when patients are feeling well but are tired of follow-up visits that require a long commute.

Pete, a middle-aged survivor of acute lymphoblastic leukemia, endured an arduous, three-year chemotherapy course. Three months into his treatment, Pete was selected (via lottery) to enter a clinical trial of blinatumomab (Blincyto®) to be taken in parallel with his chemotherapy. Within just one month, his leukemia disappeared completely, but due to risk of recurrence, Pete underwent three more one-month trial drug treatments. Today, he is dubious of the appropriateness of a decentralized approach during the active phase of a trial – which, for him, involved about 6,000 pill dosages, 200 IV transfusions, 1,000 blood tests, and 15 bone marrow biopsies (all of which required in-person visits). But he sees considerable value in a DCT approach during the maintenance and monitoring phases, which will last for the next three years.

“Now, I do video visits with my oncologist, which is much less burdensome,” said Pete. “You can’t replace in-person visits completely in the early stages of an oncology trial, but virtual technologies can ease the burden long-term.”

Better Data, Better Clinical Outcomes
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 & 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 a mobile device to measure this data more frequently and in real-time, providing improved quality-of-life insights about health impacts.
 
“We are currently using a dull knife rather than a sharp scalpel to figure these things out,” said Oakley-Girvan. “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.”
 
Medable, developer of a DCT platform that includes eCOA, ePRO, and other data-gathering technologies, supports oncology research through participation in the National Cancer Institute’s (NCI) Cancer Moonshot initiative. One of their current studies is Digital Biomarkers for Care, which aims to measure and understand the quality of life for patients receiving cancer therapy who may experience a host of late onset and/or long-term side effects. The study uses DCT technologies for passive, continuously measured and analyzed data streams bolstered by connected wearable sensors to be used outside the clinic. This data is paramount in identifying which endpoints best reflect quality of life, predicting disease, and providing symptom alerts within specific populations.
 
A first step in this decentralized study was to gather input from patients and caregivers on how well mobile phone apps combined with physical monitoring of exercise activity by a smartwatch would benefit the quality-of-care patients are receiving. In a 28-day study, patients and their caregivers reported that the remote data capture method was helpful and supported the approach.
 
Change Mindsets Now, Change Oncology Research Forever
Elizabeth Abraham, RN, BSN is a senior clinical research nurse at Mass General Cancer Center, specializing in breast oncology. Her group coordinates care for hundreds of cancer patients and connects many of them with about 50 trials being conducted at the hospital. According to Abraham, virtual screening can be performed using patient records and video consultations before patients come in for the necessary in-person tests, such as EKGs, CAT scans, or blood work. Consent can also be obtained virtually, reducing burden on trial participants during a time when they feel the worst.
 
Once a patient is enrolled, local labs can be used for some of the follow-up period to reduce travel time. Drug is shipped out by express courier directly to the patient’s home. Depending on the trial, an electronic or paper drug diary accompanies the drug 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!”
 
Besides the convenience to the patient and the closer degree of continuous monitoring, DCTs benefit the investigators and overall clinic operations. Physicians have more “chair time” to interact with patients (either virtually or in-person), waiting times are reduced for everyone – not just for the patients involved in the trial but all patients, and physicians can be more productive with their time.
 
In working through the technicalities of oncology clinical trials, with the complexities of diagnostic requirements, dosage titrations, and so much more, it’s understandable there are holdouts to accepting a new tech-driven approach to research. After all, the life sciences industry is risk-averse, for good reason. Yet, if it remains rooted in old ways, research never moves forward – and we are already seeing evidence of DCTs enabling important quality-of-life research, a major factor in the progression of care.
 
Interesting, a new study reports that sponsors and CROs plan to run more hybrid clinical trials in 2022 than traditional studies and 46% of respondents expect to run an oncology study utilizing DCT in the next year, vs. 35% for the previous year—making oncology the most prevalent DCT category.  
 
Let’s continue the momentum by changing mindsets regarding approaches to cancer research. As Pete put it, “Maybe you can’t replace in-person visits completely in oncology research, but there’s a place for technology to ease some burdens on the sickest of the sick and their weary caregivers, while giving time back to trial participants over the long-run. There’s such value in that, as any cancer survivor will attest.”
 

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Candice Del Rio is the director of clinical operations at Curavit Clinical Research, a virtual contract research organization (VCRO) specializing in decentralized clinical trials across therapeutic areas. She is a registered nurse with over 12 years of experience in oncology and clinical research. Del Rio received her BA from Boston College and BSN, MS from Northeastern University. She enjoys spending her free time with family and friends and beating her personal best in distance running. Del Rio can be reached at candice.delrio@curavitclinicalresearch.com.