publication date: May. 1, 2020

Guest Editorial

The pandemic of COVID-19 and its effect on clinical trials in the community

How do we move forward?

James N. Atkins 

James N. Atkins, MD

Co-Principal investigator

Southeast Clinical Oncology Research Consortium NCORP

This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.

This pandemic has affected a lot of people, both physicians and patients, physically as well as emotionally.

There are patients who have become afraid to come into the office to see the staff for fear that they would contract the virus. Our patients seem to have more depression, which may stem from a lack of social interaction.

We have all had our practices turned upside-down, we have gone from face-to-face visits, which we love, to computer-to-computer, or phone-to-phone visits. We have seen physician reimbursement plummet and colleagues stress about their ability to run a private practice.

Physicians have been concerned about their ability to pay the bills as well as their own mortality from this invisible enemy.

We are seeing PTSD in practitioners.

This virus, like cancer, has turned a lot of lives upside-down, and perhaps has shown us what our patients face on a daily basis.

Some patients whom I have seen have been treated on clinical trials in large cities and have been told that they cannot come back to the city for therapy due to the COVID lockdown. They have been referred to our communities to get their clinical trial therapy.

We are treating patients on clinical trials, but they are on trials that we do not have open. This would have been unheard of a few weeks ago. It would be a major protocol deviation, but should it be?  What can we learn—and what should we learn—from this pandemic when it comes to clinical trials and audit time?

Getting patients in to be seen on time (as per protocol) has been more difficult due to patients’ fear about going to the hospital, a doctor’s office or the concerns about social distancing on the way to or in the office.

In the past, we could get tests done when we wanted them—within a day or two. Now, a CT scan will have to be classified as STAT in order to get it done on a certain date.

We would never had ordered it STAT in the past, as it may cost more; but now we have to. With COVID, the x-ray departments have changed their protocols so as to have more time available for COVID patients and to conserve supplies. So our patients who need x-rays are delayed.

Some of our nursing staff may have been furloughed or redeployed due the pandemic as the hospitals are losing money and they are trying to maintain a balance sheet that is already negative.

One of the offices in our NCORP have had their staff furloughed, with just a manager left behind, 6 of 19 offices are trying to do 75% to 90% of their work remotely, and 10 of 19 continue to work in-house.

There has been a significant decline in NCTN accruals to clinical trials over the past month nationally. It also seems that there has been a significant decrease in new cancers over the past month as well. The decrease in cancers is probably due to people being afraid to come to see a doctor—or the procedures to diagnose the cancer is considered elective.

Some of the practitioners, doctors included, are afraid to see patients for fear that they may get the virus from the patients and then get sick or die. We are seeing more patients with virtual visits, and this is good in that it does decrease the exposure of our patients to others. However, this makes documenting for clinical trials more difficult.

Those of us treating patients worry about deviations from protocols and the protocol violations that then occur.

The good thing is that there are people in the clinical trial organizations and the NCI who do understand what’s going on. We believe that the problems of the pandemic will be considered when it is audit time.

We are having problems getting procedures done like colonoscopies for iron deficiency in the older population, and needle biopsies of lung lesions when we need them. We have found that we have to be more insistent on what we want and when we want it, as others may not understand.

I had a patient who needed a lung biopsy after her third cycles of therapy, and radiology was not very happy, because we already had a diagnosis of lung cancer, we had not been clear enough in our request.

We are also having problems getting tests done within the eligibility time window, just getting pulmonary function tests or a Cardiac Echo may take time.

What can we learn from this pandemic? What can we do to make changes that will improve clinical trials in America? Can we have a system where physicians are approved by some organization as being physicians that have demonstrated good practice with clinical trials and those so designated be allowed to work across trials from different sites?

It seems like we have seen a significant drop in accrual to clinical trials over the past year or two, as trials became more precision-based. COVID has just made this worse.

I fear that we are getting down much closer to 1% of adults going on trials not the 3% of the past. Should a patient be able to go 200-400 miles away to get started on a trial and then be allowed to get some or all of their follow-up treatment closer to home if it is agreeable with all the providers?

I think it is worth considering.

The easier we make it for a patient to go on a clinical trial and the easier we make it for their follow-up, the better we will do with accrual and changing the therapy for cancer.

If this is a time for change, then we need to re-evaluate the barriers for patients going on trial.

These may range from a lack of clinical trial training in our training programs, to physician apathy and burnout, ability to open trials due to lack of staff, patient trust, and financial support just to name a few.

We have to decide how important it is and whether we want to try to fix it—or whether the status quo is acceptable.

Copyright (c) 2020 The Cancer Letter Inc.