COMMENTARY

Cancer Research at a Crossroads: Adaptation Is Key

David J. Kerr, CBE, MD, DSc

Disclosures

September 14, 2020

This transcript has been edited for clarity.

Hello. I'm David Kerr, professor of cancer medicine from University of Oxford.

Today I want to talk about the impact that the pandemic is having, and will have, on cancer research.

One of the great triumphs of our global cancer community is the degree of collaboration we have in trying to put as many of our patients as we can into clinical trials to answer whatever is the important question of the day. This global approach has been imperiled by the pandemic. If we consider the patient, sponsor, host organization, clinical chief investigator, and regulatory authorities, one thread that links all of these is patient safety. How can we maintain patient safety in a clinical trial at a time when many of us are locked down and patients are nervous about going to the hospital and healthcare facilities?

We know from the trial sponsor's point of view that the host organization may have difficulty providing access to clinical facilities because of the need to reroute patients who are COVID-19–positive or -negative. In addition, clinical staff have been redeployed. Our research nurses are now helping to support delivery of chemotherapy on the front line. Some of our junior doctors and fellows have been moved out of the cancer center to work in the general wards and look after COVID-19 patients.

Our access to diagnostic tools, scans, and blood tests is also limited because they have been reprioritized to support the tsunami of COVID-19 patients we're seeing in the hospitals.

In a time of limited resources, we need to be able to adapt. One of the most important things we've done in our office is to reassess the risk-benefit ratio for all of our patients. We think about whether it is safe for our patients to continue on the trial, and if they pick up the virus, whether this could 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, and to take those patients who have been recruited off the experimental treatment. Another would be to halt new recruitment but continue to monitor patients who have already been enrolled in the trial. The third approach, and perhaps the most logical, is to adapt and amend how we monitor trials to maintain patient safety. The biggest element of that is to use telemedicine to follow up with patients, ensuring safety, capturing data remotely, and making sure that the data trails continue to be important. During this time, the regulatory authorities have been flexible in allowing remote (rather than face-to-face) consultations and remote access to patients' electronic health records.

The wrinkle with this is that we must maintain patient confidentiality at all times. If we allow our host organization monitors (eg, clinical research associates, contract research organizations, trial intermediaries) to remotely access patient data, we must get explicit consent from patients so that they understand that their data are being looked at offsite.

We also must ensure that those who are reviewing the data fields necessary for clinical trial follow-up do so within an environment that maintains patient confidentiality. This is extremely important. For example, you wouldn't want a trial monitor to access potentially sensitive confidential information 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.

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

In the United Kingdom, we are wonderfully well supported by government and 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. Their income has been hit hard by the pandemic and the lockdown. Therefore, for a period of time, it will impair the ability to fund good science.

I'm sure governments around the world will be shifting some of the focus of their research away from conventional disease areas and toward virology, to develop better drugs and vaccines and to invest in their healthcare systems' pandemic preparedness. I believe that all governments will have to re-examine how they responded to this pandemic, which will have consequences for us all.

The potential upside is that remote patient care is here to stay. I run my clinic on Friday mornings from my kitchen table. I can do it safely, effectively, and morally, while providing emotional support. If we can do that for conventional patient care, we can adapt it to how we follow up with patients in clinical trials. I also believe that using mobile phone apps to collect data on side effects and patient-reported outcome measures is here to stay and will make a real difference.

As a university employee, I've been trying for years to get full access on university computers to the patients I care for within our national healthcare service. It's been an uphill battle. But with COVID-19, we seem to have accomplished in 5 days what we couldn't accomplish in 5 years. So there has been a momentum behind embracing digital health and newer technologies for looking after patients. The politicians say never let a good crisis go to waste. Perhaps in that sense, we have moved our care of cancer patients forward.

We realize that it's an interesting and difficult time for us all. We're exploring all aspects of COVID-19 and clinical care in many chat forums. But in thinking about cancer research and its importance to the community of patients we serve, it has been impactful. Through adaptation, I believe that we can come through this together and be stronger for it.

As always, thanks for listening. Keep well and stay safe. For the time being, Medscapers, over and out.

David J. Kerr, 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 II.

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