Coronavirus 2019 (COVID-19) has disrupted oncologic care across the spectrum of cancer screening, diagnosis,1 and governance.2,3 Clinical trials are critical in providing quality oncological care. However, there are several challenges to oncology clinical trials, including enrollment, health care differences, patient access, and interest in participation. Nevertheless, clinical trials are essential for the care of patients with rare cancers that require treatment beyond the standard of care. Because of COVID-19 pandemics, conducting clinical trials, particularly patient registration and monitoring, poses a major challenge, and there are concerns about the negative impact on cancer outcomes and delays in getting new drugs to market and for patients far and wide.4
The FDA, National Cancer Institute, other clinical organizations, and various clinical trial advocates responded.
Following the declaration of COVID-19 as a national emergency on March 13, 2020, the FDA issued draft guidance on the conduct of clinical trials of medical products during the emergency. The FDA recognized that clinical-protocol testing may be necessary to ensure patient safety and that movements may arise with protocol-guided procedures.5 This timely guidance document enabled researchers, industry and academic institutions to work with their institutional review boards to determine the pandemic.6 The first response among test sponsors was to maintain new patient registration while ensuring the safety of routine test participants. Researchers also saw a diffuse control environment, with increased inclusion of telehealth and remote patient care visits into clinical trial protocols. Although clinical trial enrollment initially decreased,7 efforts to increase COVID-19 testing and knowledge helped resume new patient registration.8.9
It is widely acknowledged that COVID-19 has led to a “democratization” of clinical trial behavior – with increased telemedicine uptake and seizures. In addition, a smaller load of tests and a smaller proportion of localized and infrequent tests have led to increased patient comfort while at the same time reducing the administrative burden. The provision of subcutaneous injection and drug administration has improved compliance and facilitated administration. Finally, the reduction of strict follow-up restrictions has allowed for greater participation of patients with limited travel capacity.10
Overall, this could lead to a technological shift in the conduct of clinical trials, with an emphasis on patient choice and safety while maintaining scientific integrity.11,12 This will ensure extended clinical trial access, possibly increasing communication and participation, and then reducing patients ’concerns for participating in clinical trials. Among the pandemic, Massive Bio, Inc. added. the Sync-AI Oncology Clinical Trial Control Center (OCTCC) launched. OCTCC’s mission is to eliminate and accelerate the clinical trial registration process by optimizing workflow efficiency, performing in silico clinical trial registration simulations during the patient journey, and minimizing to significant time between patient identification and registration.
Finally, the pandemic has shown increased interest in acquiring digital health solutions for clinical care. For example, collaboration between American Cancer Treatment Centers and CVS Health led to a Home Oncology Clinic, which provides home chemotherapy for clinically eligible and insured patients.13 According to a press release from CVS Health, the initiative will reduce the number of patients with COVID-19 from outpatient or hospital settings during the ongoing pandemic, allowing for ongoing cancer care.14
Another tool developed to combat the pandemic is the Remote Patient Surveillance Program (RPM) developed by the Mayo Clinic. This program, led by the Mayo Clinic Connected Care Center, uses medical technology and tools delivered to patients ’homes so that vital signs and symptom assessments are scrapped daily. A team of RPM nurses regularly monitors the data and communicates with patients to assess health and progress toward health goals. The program was developed to support patients with complex breast diseases.15As part of the program, 2 pathways were developed for patients with COVID-19: one for patients with comorbidities at moderate to high risk for complications and one for patients with lower risk.
Patients enrolled in the high-risk program receive an RPM package that includes blood pressure loops, a thermometer, a pulse oximeter, and a weight scale. Patients use these devices 2 to 4 times a day to measure their vital signs. These measurements are automatically transmitted to the Mayo Clinic through a cell-enabled register that patients receive with their kittens. RPM nurses also call patients to determine if they are experiencing symptoms such as nausea and shortness of breath. Patients at lower risk for complications register vital signs using the Mayo Clinic app. Every day, these patients receive a notification on their mobile device telling them that they need to provide information to their care team through the app. Patients can register after speaking to their healthcare providers and have direct contact with their care teams through remote monitoring.
While the long-term effects of COVID-19 on the behavior, methodology, and recording of cancer clinical trials remain unclear, we suspect that there are significant innovations in clinical care delivery and research, increasing opportunities for collaboration. operation, and participation (FIGURE). Perhaps this harsh dilemma from COVID-19 certainly underscores the shift that health care needs to deliver in a new era of patient-centric cancer care delivery.