The COVID-19 pandemic has resulted in a number of changes to patient care, particularly in hospitals with high numbers of COVID-19 cases. For some patients with cancer, the pandemic has resulted in changes to their treatment and/or the replacement of in-person hospital visits with virtual patient assessments.
The COVID-19 pandemic has also led to adaptations in cancer clinical trial protocols that affect how patients take part in studies. In the United States of America, the US Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) has published guidance detailing the best practices for clinical trial protocol changes to address the risks that patients may face when taking part in a clinical trial during the COVID-19 pandemic.
This includes temporarily or permanently halting some clinical trials due to staff shortages, potential supply chain issues, or concern over the safety of patients. Clinical trial staff will communicate with patients if the clinical trial is halted or if any parts of the trial are delayed or changed. Some patients currently enrolled in a clinical trial who have not yet started treatment may be delayed while others may continue receiving the treatment as planned.
During the COVID-19 pandemic, many hospitals shifted in-person visits to virtual assessments to limit patient contact. This requires a reliable internet connection
Patient assessments such as imaging or biopsy/blood collection may be delayed to reduce the risk of COVID-19 and ensure sufficient staff are available. Some patient may be required to go to a hospital closer to home for their assessments to reduce travel.
During study visits, patients will be asked about symptoms associated with COVID-19, as well as known exposure to someone who has tested positive for SARS-CoV-2. Patients might also be tested for SARS-CoV-2 and show proof of a negative result before their visits. Alternatively, they might be tested during their visit. Patients will also be required to wear a face covering and socially distance from others during their visits.
Some trials may stop treatment if the trial investigators and/or sponsors think it too risky. Some trials may alter the treatment interval (e.g., from weekly dosing to biweekly dosing) to limit the number of in-person visits. Some trials might also include treatment that can be taken at home. Oral drugs may be distributed by a local pharmacy or mailed to the patient’s home.