The Challenge of Continuing Clinical Trials

What your doctor is reading on Medscape.com:

APRIL 22, 2020 — The impact of COVID-19 on national and international cancer research has been devastating. Across the world, access to cancer services has been affected, and this includes the opportunity to consider a clinical trial for a patient. Major centers have placed a hold on enrollment, national trials have been suspended, and trials about to launch have been delayed. This has been a personal issue for me; I am running a trial on a very rare form of ovarian cancer—clear cell cancers—testing two strategies of immunotherapy.

I have relied on colleagues from across the country to support it. I’ve had women travel from as far away as South Dakota to participate. When COVID-19 hit the US and erupted on both coasts, several women were already enrolled in the study, a few of whom were traveling from other states. The biggest issue we faced was obvious: The protocols specified that physical exams and treatments should be done in Providence. Would we be able to continue the clinical trial?

Would it be ethical to force these women to make a choice between staying in the trial and receiving treatment—but risking COVID-19 exposure—or dropping out of the trial and forgoing treatment?

As weeks went by, there were additional obstacles. Per state orders, visitors to Rhode Island were asked to quarantine for 2 weeks. Could I realistically ask a woman to come for her treatment and then stay in a hotel room for 14 days afterwards?

The FDA has offered guidance aimed at protecting patients while still allowing them to continue in clinical trials. They suggest that protocols could be modified to include conducting visits via telehealth, for example, but that above all, the integrity of the trial should remain intact.

But the guidance did not offer concrete steps regarding doing what I thought was most essential: allow women to be treated with the study drug locally. I and my colleague, Roxanne Wood, director of the Brown University Oncology Research Group, reached out to the FDA via email. Ultimately, they said it was possible to send the trial drugs to a local physician for administration and still retain the patient in the clinical trial.

This turned out to be only half the work required. I spent days talking with patients and the colleagues who had referred them; in all cases, they chose to stay in the trial.

I then had to speak with the leaders of each center’s research, nursing, and pharmacy groups. Here there was more reticence; I met with significant doubts that we could conduct our clinical trial under standard operating procedures. After all, how could a local institution participate in a trial without altering the protocol? Under normal circumstances it would be an impossible ask. Yet, realizing that nothing is normal at the moment, their institutions found ways to help and ultimately agreed to collaborate.

Next came approval of our own Institutional Review Board. For those who do not conduct clinical research, the board’s main goals are to protect patients and their privacy, and to ensure that clinical trials are conducted according to national and international standards. Here, too, I expected some resistance, but instead they acted quickly, given the pandemic, and approved my request to deviate from the protocol.

Finally, I had to engage with the drug sponsor. This proved to be the easiest part. They agreed to provide the drug to my patient at her local institution and did what was necessary to get the requisite paperwork completed.

Some days I felt like I was hitting my head against a wall; on others I felt like Moses parting the Red Sea. Most often I felt that it would just be easier to insist that patients come to me for trial treatment, yet I knew that this was not the best course of action. I don’t conduct clinical trials to help myself—the point is to help patients. Now was not the time to forget that.

The pandemic has brought so much disruption; nothing is normal. But it’s also been incredibly moving to witness the power of our communities. This experience has shown me that I am part of several: the community within my institution, within my specialty, and also within a national clinical research community. And each one is trying to do what is best to keep trials open and operating, even during this ominous period in our country.

Don S. Dizon, MD, is an oncologist who specializes in women’s cancers. He is the director of women’s cancers at Lifespan Cancer Institute and director of medical oncology at Rhode Island Hospital.