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Coronavirus has an impact on clinical trial participants

Cancer clinical trials and COVID-19 (Coronavirus)
Tuesday, March 31, 2020
Coronavirus has an impact on clinical trial patients

As the health care systems in Canada ramp up to meet the coming COVID-19 (Coronavirus) challenges, the Canadian Cancer Trials Group (CCTG) recognizes that this may have an impact on the conduct and availability of cancer clinical trials.

People living with cancer are at an increased risk from COVID-19 because of underlying medical conditions and a compromised immune system. Patient care, safety and well-being are a priority while we work to minimize the impact and duration of this pandemic.

Challenges for patients participating in a trial may arise from; social distancing requirements, cancer centre restrictions, travel limitations, interruptions to the supply of investigational products, or because of the strain on hospital resources.  These challenges may lead to difficulties in meeting trial-specified procedures, including following trial-mandated visits or follow-up, and access to laboratory or diagnostic testing.

For those patients volunteering in a clinical trial, protocol modifications may be required, and could result in unavoidable trial deviations due to COVID-19 illness, exposure and centre control measures. The impact of necessary healthcare control measures on trials will vary depending on many factors; the type of cancer being studied, the trial design and where the trial is being conducted.

All cancer centres that conduct clinical trials must follow institutional, provincial and national directives relating to COVID-19, which are evolving rapidly. Efforts are underway to monitor ongoing changes and reduce risks to trial participants and their families, hospital staff and the public.

Across the country, health care organizations, Research Ethics Boards and trial sponsors have been developing guidance for the management of patients with cancer who are currently participating in a clinical trial or eligible patients who are considering participation. They are also looking at the impending COVID-19 burden on our health system and the impact this may have on clinical trials activity.

Recognizing that patients with cancer require treatment options and that clinical trials provide access to promising therapies, health care institutions are assessing their resources to ensure support of ongoing trial activity within the context of the anticipated impact of COVID-19.  Patients and their families are encouraged to discuss the risks and benefits of continuing on the trial or switching to standard of care with their clinical team.

Enrollments and new trials

Cancer centres may be limiting the registration of new patients to currently open trials or the activation of additional trials based on their assessment of available staff, health care resources and patient safety. Setting priorities for new patient enrollment or the activation of new trials includes a number of considerations; the available standards of care, the potential benefit of the therapy, the potential for adverse side effects and the health system resources needed to conduct the trial.

Ongoing trial participation

For current trial participants, efforts are underway to ensure safety, care and continuity of treatment schedules while on the trial. Scheduled visits and investigations or tests could be modified in frequency, type or location – for example, a phone call follow-up instead of a site visit or an assessment by a health care professional at a different location.

Trial patients, and in fact, all patients, will likely be contacted before a clinic visit to actively screen for COVID-19 infection. Decisions regarding trial conduct are being updated continuously as new information becomes available so please make sure you are aware of any changes at your local centre by contacting your health care team.

If you are looking for support during this time, the Canadian Cancer Society (CCS) has online resources available: toll-free helpline, peer match program and online peer support community.