COMMENTARY

A Pandemic Silver Lining: Cancer Research Is Going Remote

David J. Kerr, CBE, MD, DSc

Disclosures

July 22, 2020

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This transcript has been edited for clarity.

I'm David Kerr, professor of cancer medicine from University of Oxford. Today I'd like to talk about the impact that the COVID pandemic is having and will have on cancer research.

One of the great triumphs of our global cancer community is the degree of collaboration that we have in terms of trying to put as many of our patients as we can into clinical trials to answer important questions. I think this global approach has been imperiled by the pandemic.

If we consider the patient, the sponsor, the host organization, the clinical chief investigator, and the regulatory authorities, the one thread that links all of those is patient safety.

How can we maintain patient safety monitoring in a clinical trial at a time when many of us are locked down and at a time when patients are genuinely nervous about going to the hospital and accessing conventional healthcare facilities?

We know that from the sponsor's point of view, the host organization may have difficulty providing access to clinical facilities because of rerouting of patients. Many clinical staff have been redeployed. Our research nurses are helping to support delivery of chemotherapy on the frontline. Some of the junior doctors and fellows have been moved out of the cancer center to work in the general wards, looking after COVID patients. Access to diagnostic tools, scans, blood tests, and so on is also limited because these have been reprioritized to support COVID patients within the hospital.

Adapting Our Approach to Research

In a time of limited resources, we need to be able to adapt.

One of the most important things that we've done in our trials office has been to reassess the risk-benefit ratio for all of our patients. We think about whether it is safe for our patients to continue on trial, and if they were to pick up the virus, could this have calamitous additional effects? That's the starting point.

Having carried out the risk-benefit assessment, there are three responses. One is to suspend the trial completely, with no further recruitment. Those patients who have been recruited will be taken off the experimental treatment.

The second would be to halt new recruitment. Keep patients on trial who have already been added, and watch over, care for, and monitor them, but with no further recruitment.

The third and perhaps the most logical is to adapt and amend how we monitor trials and how we maintain patient safety throughout.

The biggest element of this approach is using telemedicine for following patients, ensuring safety, and capturing data remotely — the data trails that continue to be important for any trial. There's no doubt that the regulatory authorities have been flexible in allowing the possibility of remote rather than face-to-face consultations with patients and using remote access to patients' electronic health records. There's an important wrinkle with this for research, though, because we must maintain patient confidentiality at all times.

If we are allowing our host organization monitors, CRAs, CROs, and trial intermediaries to access patient data remotely, we must get implicit consent from patients so that they understand that their data are being looked at remotely offsite. I think we must ensure that those who are reviewing the data necessary for clinical trial follow-up do so within an environment that maintains patient confidentiality.

For example, you wouldn't want a trial monitor to be accessing potentially sensitive confidential information if they're living at home or in a busy, crowded environment in which other people might be able to view what they're doing just by looking over their shoulder.

Silver Linings

Will anything good come from this crisis? It is difficult to say just now. What worries me is that I think there will be a negative impact on funding for cancer research and clinical trials.

In the UK, we are wonderfully well supported by government and by charity. Cancer Research UK is one of the largest charities in the world and has an enormously powerful vision for the future of cancer research. But their income has been hit hard by the coronavirus pandemic, and therefore their ability to fund good science will be impaired for a period of time.

I'm sure governments around the world will be shifting some of the focus of their research away from conventional diseases and toward virology, better drugs, better vaccines, and healthcare systems and pandemic preparedness. All governments are going to have to reexamine how they responded to this pandemic, and I'm sure that will have consequences for us all.

A potential upside: I think that remote patient care is here to stay. I run my Friday morning clinic sitting at the kitchen table, and I think I can do it safely, effectively, morally, and with emotional support for my patients.

If we can do that for conventional patient care, we can adapt that and translate it to how we follow patients in clinical trials, such as using mobile phone apps to collect data on side effects and patient-reported outcome measures. I think that's here to stay and will make a real difference.

We've been trying for years as university employees to get full access on university computers to the patients we care for within our national healthcare service. It's been an uphill battle, but with the COVID outbreak, we seem to have accomplished in 5 days what might have been accomplished in 5 years.

There is now momentum behind embracing digital health and using newer technologies to care for patients. The politicians say, "Never let a good crisis go to waste." And so perhaps in that sense, we have moved our care of cancer patients forward.

David J. Kerr, MD, CBE, MD, DSc, is a professor of cancer medicine at the University of Oxford. He is recognized internationally for his work in the research and treatment of colorectal cancer, and has founded three university spin-out companies: COBRA Therapeutics, Celleron Therapeutics, and Oxford Cancer Biomarkers. In 2002, he was appointed Commander of the British Empire by Queen Elizabeth.

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