By Megan Liles, Vice President, Operational Strategy, Precision For Medicine
A relative was diagnosed with breast cancer last October. When she went for her first infusion of chemotherapy, a woman covered in personal protective equipment (PPE) came up and started talking to her. All my relative could see was the woman’s eyes. Dumbfounded, she asked, “Who are you?”. “I’m your doctor,” the woman replied.
When I told that story at a recent roundtable, a participant revealed that she had had the same experience with her doctor, whom she did not recognize beneath the PPE. Stories like these illustrate how COVID-19 has impacted care. Patients increasingly feel vulnerable, isolated, and exposed as they try to navigate the healthcare system by themselves. Many lament the loss of personalized care and comfort. Some express frustration with telemedicine, a mode of care in which physicians can appear to be rushed, under pressure to finish consults as quickly as possible.
Another consequence of the pandemic is widespread adoption of virtual clinical trial designs propelled by digital technologies and decentralized modalities. Sponsors and contract research organizations (CROs) are increasingly using digital technologies such as artificial intelligence-driven patient-trial matching and electronic consent platforms to streamline recruitment and enrollment and to make trials more accessible and inclusive. Other innovations such as telemedicine, alternative site locations, digital monitoring technologies, electronic patient-reported outcomes, electronic clinical outcomes assessment, and home-based delivery of medications are making virtual trials more feasible as they generate real-world evidence.1
Although virtual trials are a logical response to COVID, and can be highly beneficial to patients and investigators, the virtual model may not be ideal for oncology trials. Over-reliance on technology leaves little room for human interaction. Most anticancer medications are administered via intravenous infusion and are therefore not well-suited for at-home administration. Indeed, the American Society of Clinical Oncology advises against home infusion of anticancer therapy.2 Moreover, the loss of a personal connection can exacerbate the disease burden and feelings of isolation for persons with cancer.
The need for the human touch in oncology trials
The ravages of the pandemic underscore the need for a hybrid, humanistic approach to oncology trials, one that heeds a basic principle: behind each patient is a person dealing with a disease. Ideally, the hybrid model combines the best elements of decentralized and site-based trials, intermingling on-site visits with telemedicine and remote monitoring. This can give patients valuable face time with their physicians while allowing them to maintain their connection with site staff between visits.
Deployment of satellite sites can facilitate a hybridized trial with a personal touch. In addition to enhancing patient access to trials, satellite sites can ease the logistical burden by allowing patients (and caregivers) to go to a more convenient site, eliminating the need to travel to the main academic site in a large metropolitan area.
We can also facilitate hybridized trials through regionalization, particularly by establishing sites at community-based and regional hospital systems. Institutions such as the University of Nebraska or the University of Nevada can be attractive alternatives to major metropolitan centers. Moreover, the less heavily trafficked centers may have large numbers of patients receiving care; for many such patients, clinical trial participation may be a care option.
Expanding the patient pool
Human interaction helps to normalize trial participation for ethnic minorities, rural inhabitants, and other populations that are under-represented in clinical research. This approach can also facilitate enrollment of greater numbers of patients at time of diagnosis, when they are more likely to benefit from intervention. Methods such as geo-targeting, which leverages claims data, electronic health records, and internet usage data, can help to identify potentially eligible patients located near trial sites. Such information can be used to develop detailed patient profiles to enhance understanding of patients’ socioeconomic status, potentially providing insights into individuals’ ability and/or willingness to participate.
Sites can also increase participation by instituting flexible scheduling -- extending or expanding site hours -- to accommodate patient schedules. Opening at an earlier hour, or closing later once or twice a week, can make participation significantly easier for patients.
Treating the whole person
The hybridized model enables a more holistic approach focused on treating the whole person, not merely screening the patient and treating the cancer. It can also be a key differentiator in the crowded, highly competitive oncology trial marketplace. Our experience suggests the hybrid approach can improve outcomes and quality of life, while also enhancing patient engagement and retention. For patients, access to the entire research team enables a higher level of care; many patients tell us they feel better having other people (i.e., aside from medical staff) to talk to about their disease. Studies can also deploy patient navigators to help patients with logistics, relieving the burden on site staff.
The hybrid, humanistic model is informed by greater knowledge and appreciation of individual patients’ preferences and characteristics, including their genomic/molecular profiles. Sponsors can facilitate this model by engaging a CRO with clinical teams offering vast experience in oncology and strong relationships with clinical sites. Such an approach can help accelerate the future of medicine.
1. Kadakia KT, Assad M, Adlakha E, Overman MJ, Checka CM, Offodile AC II. Virtual clinical trials in oncology – overview, challenges, policy considerations, and future directions. J Clin Oncol Cancer Inform. 2021;5:421-425.
2. American Society of Clinical Oncology Position Statement: Home Infusion of Anticancer Therapy. American Society of Clinical Oncology; 2020. https://www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2020_Home-Infusion-Position-Statement.pdf.