COVID-19 Pandemic & Cancer Trials: National Clinical Trials Network Evolves & Adjusts for New Reality

COVID-19 Pandemic & Cancer Trials: National Clinical Trials Network Evolves & Adjusts for New Reality

Funded and managed by the National Cancer Institute, the National Clinical Trials Network (NCTN) represents critical infrastructure including investigators for over 2,200 cancer clinical investigational sites across the United States in support of cancer trials. Although NCTN remains open during the COVID-19 pandemic, much of its work has fallen in the priority line to clinical care. Those patients with SARS-CoV-2, the virus behind the COVID-19 pandemic, are now front of the line. Those within NCTN that do get research attention may, unfortunately, be subject to triage formulas as there isn’t the redundancy and infrastructure for both caring for COVID-19 patients and maintaining the NCTN at full capacity.

Unprecedented Times

Tens of thousands of cancer patients face, in some cases, grave risks as critical decisions for who receives chemotherapy, tumor resection, irradiation, or a transplant must be made by provisional decision-making factoring in a number of critical factors depending on location and circumstance. As reported in The Cancer Letter, these are extraordinary times.

The World of NCTN: Research is a Care Reality

The researchers of the NCTN should be commended as they continue to conduct clinical trials. In many cases, they do this out of a sense of duty as many cancer patients participating in the clinical trials are in bad shape. With late stage cancer cases, research becomes a care necessity for certain patients. That they would certainly face severe consequences, including death, is known by all in participation. Hence NCTN continues to treat patients already on studies, and if circumstances permit, accrue new patients to existing studies. In some cases, they will launch a new high-priority clinical trial—even in a pandemic!

Sign of the Times

NCTN study enrollment levels continue to decline and have been doing so since March 23. Of course leadership expects continued enrollment decline ’till the pandemic ends and the society pivots to whatever comes next. Although NCTN investigators keep trials moving forward where they can, some studies have been suspended. Undoubtedly, these are associated with heart breaking stories. Reports of stoppages or suspensions include the critical National Community Oncology Research Program (NCORP) where there were disruptions to cancer screening and cancer care delivery. NCORP embodies the concept, spirit, and soul of the clinical research as a care option movement for cancer patients.

Telehealth: Here to Stay?

The Cancer Letter reports that thankfully, NCI has modified certain rules during the crisis to support research operations. From the suspension of audits to delaying data submission deadlines to full support of telehealth where the protocols support—in these cases, certain oral agents are being shipped to patient homes via trackable methods from firms such as FedEx. Thanks to these nimble and adept moves, it can potentially free up physician constraints and keep oncology research moving in at least some cases. A number of other NCI rules are either being relaxed or under consideration.

Introducing the COVID-19 Cancer Consortium

Just weeks into the pandemic, a group of cancer physicians and scientists launched the COVID-19 and Cancer Consortium (CCC19), a national and imminently international research initiative. As reported by The Cancer Letter, CC19 has set up an online form to collect de-identified, HIPAA-exempt data from oncology patients infected with COVID-19.  Vanderbilt University created the survey while Fred Hutchinson Cancer Research Center and a number of other participating investigational sites and hospitals approved the survey.

A COVID-19 Oncology Patient Registry

This survey is used to collect all sorts of data about oncology patients infected with COVID-19 such as demographics, clinicopathological factors, their SARS-CoV-2 diagnosis and treatment details, as well as health care provider details.  The patients and their outcomes will be tracked over time with the hopes that meaningful research can be undertaken at some point after the crisis subsides. This registry is led by heavy hitters within the NCTN network.

Lessons of War

The NCTN leadership understands that the nation’s health system was not prepared for this pandemic—the cost in human life and economy is dear. They understand that they must learn from this pandemic; that tools such as teleconferencing and telemedicine will now be the norm; that managing trials smarter; faster and with more pragmatic flexibility is of necessity and not luxury.  Just like medical battlefield lessons during war, this is no different—after all, COVID-19 represents a war in the sense that it is a pathogen at war against people around the world.

Moving Forward

NCTN will be run differently in the future. Processes, systems, and protocols will be adjusted to reflect not only what has been learned, but what makes sense moving forward. After all, the mission of NCTN is the pursuance of clinical trials because they contribute to a reduction in the burden of disease and human suffering.