Arturo Loaiza-Bonilla MD, MSEd

Coronavirus disease 2019 (COVID-19) has disrupted oncologic care across the spectrum of cancer screening, diagnosis,

 Clinical trials are integral to providing quality oncological care. However, various challenges exist in the conduct of oncology clinical trials, including enrollment, health care disparities, availability, and patient interest in participating. Despite this, clinical trials are vital for the care of patients with rare cancers requiring treatment beyond the standard-of-care therapy. Because of the COVID-19 pandemic, the conduct of clinical trials, especially patient enrollment and monitoring, faces serious challenges, and concerns over the adverse impact on cancer outcomes and delays in getting new drugs to market and to patients are widespread.

The FDA, National Cancer Institute, other clinical agencies, and various clinical trial sponsors collaboratively responded.

After the proclamation of COVID-19 as a national emergency on March 13, 2020, the FDA issued draft guidance about the conduct of clinical trials of medical products during the emergency. The FDA recognized that clinical trial–protocol modifications may be required to ensure patient safety and that deviations may arise with protocol-mandated procedures.

 This timely guidance document facilitated investigators, industry, and academic centers to work with their institutional review boards to navigate the pandemic.

 The initial response among trial sponsors was to hold new patient enrollment while ensuring the safety of the current trial participants. Investigators also saw a loosened regulatory environment, with increased incorporation of telehealth and remote-patient care visits into clinical trial protocols. Although clinical trial enrollment initially decreased,

 efforts to increase COVID-19 testing and knowledge helped result in resumption of new patient enrollment.

It has been widely recognized that COVID-19 has led to “democratization” of clinical trial conduct—with increased incorporation of telemedicine and virtual visits. Furthermore, reduced testing burden and allowance of local and less frequent testing have led to increased patient comfort while simultaneously lowering administrative burden. The provision of subcutaneous injection and self-administration of drugs has improved compliance and ease of administration. Lastly, reduction in stringent follow-up restrictions has enabled increased participation for patients with restricted travel ability.

Overall, this may lead to a technological revolution in the conduct of clinical trials, with an emphasis on patient preference and safety while preserving scientific integrity.

 This will ensure expanded clinical trial access, possibly increase engagement and participation, and subsequently allay patients' concerns for participating in clinical trials. Amidst the pandemic, Massive Bio, Inc. launched its Synergy-AI Oncology Clinical Trial Command Center (OCTCC). The mission of OCTCC is to disrupt and accelerate the clinical trial enrollment process by optimizing workflow efficiencies, performing in silico clinical trial enrollment simulations during the patient journey, and drastically reducing the time between patient identification and enrollment.

Lastly, the pandemic has led to increased interest in leveraging digital health solutions for clinical care. For example, a collaboration between Cancer Treatment Centers of America and CVS Health led to Oncology Clinic at Home, which provides in-home chemotherapy for clinically eligible and insured patients.

According to a press release from CVS Health, the initiative will minimize patient exposure to COVID-19 from inpatient or hospital outpatient settings during the ongoing pandemic, allowing for continuous cancer care.

Another tool developed to counter the pandemic is the Remote Patient Monitoring (RPM) Program developed by Mayo Clinic. This program, led by Mayo Clinic’s Center for Connected Care, uses medical technology and devices that are sent to patients’ homes so vital signs and symptom assessments can be screened every day. A team of RPM nurses regularly monitors the data and contacts patients to assess health and progress toward health goals. The program was developed to support patients with complex chronic conditions.

As part of the program, 2 tracks were developed for patients with COVID-19: one for patients with comorbidities at moderate-to-high risk for complications and one for lower-risk patients.

Patients enrolled in the high-risk program receive an RPM kit that includes a blood pressure cuff, thermometer, pulse oximeter, and weight scale. Patients use these devices 2 to 4 times a day to measure their vital signs. These measurements are sent automatically to Mayo Clinic through a cellular-enabled tablet that patients receive with their kits. 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 record vital signs using the Mayo Clinic app. Each day, these patients receive a notification on their mobile device letting them know that they need to provide information to their care team through the app. Patients are able to enroll after discussion with their healthcare providers and have a direct link to their care teams through remote monitoring.

Although the long-term effects of COVID-19 on conduct, methodology, and enrollment of cancer clinical trials remain unclear, we suspect major innovations in clinical care delivery and research, increasing opportunities for collaboration, and participation (FIGURE). This rigorous disruption from COVID-19 may indeed provide the nudge that healthcare needs to usher in a new era of patient-centric cancer care delivery.

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Articles

Coronavirus disease 2019 has disrupted oncologic care across the spectrum of cancer screening, diagnosis, and management.

Arturo Loaiza-Bonilla MD, MSEd | Authors

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COVID-19 and Its Impact on Oncology Clinical Trials