The continuous battle in cancer research has unfortunately fallen a bit to the backseat due to healthcare's main focus on beating COVID-19 wildfires. To bring its needed attention back up on the ladder, Marie Lamont, president and COO of Inteliquet, a clinical trial software company, shares what took place in the drop of oncology-related activity and what can be done to improve.
The continuous battle in cancer research has unfortunately fallen a bit to the backseat due to healthcare's main focus on beating COVID-19 wild fires.
To bring its needed attention back up on the ladder, Marie Lamont, president and COO of Inteliquet, a clinical trial software company, shares what took place in the drop of oncology-related activity and what can be done to improve.
Through a Clinical Research Consortium, two relatively distinct periods where there has been a drop in oncology activity were found. During the initial outbreak, the drop in activity was significant. It has been followed by a period of stabilization where counts are still generally down, but a continual decline is not seen, according to Lamont.
From March through May in 2019, as compared to the same time period in 2020, data for cancer patients, cancer-approved drugs, and procedures for all indications, each experienced notable declines. Interestingly, while cancer patient records saw a 36% decline, similar to the drop in procedures, cancer approved drugs were down only 13%.
The change between 2019 and 2020 for the March to May period was different when viewed from the perspective of individual consortium research members. While one member experienced a 59% decline in cancer patient records, most of the remaining members saw decreases between 43% and 28%. Notably, three experienced significantly lower decreases, and one member actually increased its count by 7%, Lamont says.
Five of the 12 members saw an increase in their cancer drug record counts and the remaining all experienced much lower percentage reductions in drug records as they did in cancer records. There could be many reasons, including a return to oral therapeutics as fewer patients are able to come in for infusions and even fewer may be given the options of a clinical trial. It is safer in some instances to return to the old standard of care as opposed to exposing a patient to COVID-19, she adds.
The second period, however, tells a different story. Inteliquet recently analyzed one of the largest cancer centers in their consortium and found that, although the number of COVID-19 cases surged again, it seems that over the last several months, the cancer center had acclimated to operating in the COVID-19 landscape and was more prepared to respond to the second wave.
Lamont believes cancer care took this much of a hit because in the beginning of the pandemic, the effect of COVID-19 on cancer centers and the broad oncology research community in general, was that patients weren’t going into the center unless they were acute.
Biopharma recognized this and started pausing, delaying or stopping trials altogether. At the same time, they also started to see clinical supply challenges. Clinical supply was either not deemed critical or some of the resources around clinical supply couldn’t get to where they needed to be, she says.
Also, when patients aren’t going into centers, they may not be completing their diagnoses such as getting biopsies, blood tests or biomarker tests. A drop in diagnostics has remained.
What that translates to is treatments and therapeutics are down. If you don’t have a diagnosis, you can’t determine and provide the right therapeutic response. There is a concern there is a backlog of incredibly needy patients that will need care.
An additional effect on cancer centers is on revenue. Without patients, center revenue is down. Also, without patients enrolling in trials revenue is down. This has a compounding effect on cancer centers when both traditional revenue and clinical research enrollment revenue are down.
As a result, some have had to reduce resources, and struggle to bring their staff back when resources return. Some of those staff were diverted to care for COVID-19 patients, and some have not come back, which forces the centers to focus on trying to find new staff. Also, a return of some of the “old” standard of care as opposed to targeted therapies have been seen, according to Lamont.
What needs to be done
With the American Cancer Society predicting more than 1.8 million new cancer diagnoses in 2020, she says it’s not enough to get derailed oncology clinical trials back on track. Cancer research can only do better.
Despite the pandemic, major research hospitals are expected to continue connecting cancer patients with cutting-edge treatment options. Smaller hospitals may not feel they have the financial security or bandwidth to consider clinical trials just yet. But oncology clinical trials are important because they can be a last option for some patients.
Another way to help involves electronic medical and health records. These records are reliable sources for what’s known as structured data, but they don’t always provide a full picture of a patient’s health, she says.
"When cancer center staff try to ascertain whether they have patients that match inclusion/exclusion requirements for a clinical trial, they often spend hours manually reviewing unstructured data from other sources such as physician notes and lab and pathology reports," Lamont says. "By digitizing and tracking all forms of patient data with a specialized software platform, matching cancer patients to open clinical trials becomes faster and more accurate. With proper management, we can make more cancer patients more fully visible to researchers."
Another lesson COVID-19 has taught us is that while in-person medical visits may be preferable, they are not always essential. Many of the geographic barriers that seemed to exist just months ago can be overcome with two cameras and a user-friendly computer interface.
As it did with many areas of medicine, the U.S. Food and Drug Administration revised regulations in recent months to allow components of clinical trials to be conducted via remote means. Many are hopeful elements of the FDA’s changes will remain in place, but whether you currently live in a COVID-19 hotspot or a seemingly safe haven, it’s essential that hospitals and clinics develop resilient plans to restart oncology clinical trials, she adds.
Lastly, there remains a need for more research and researchers in the community care environment, she says.
"Community settings are ideal for clinical research because 80% of cancer patients receive care in the community oncology setting," Lamont adds. "Yet, historically, research is still more common in large academic settings. If we increase researchers in the oncology setting, we will be putting trials where the patients are—and that is an excellent way to ensure that clinical trials are a care option for more patients and their providers."
In a crucial period where some healthcare organizations and life sciences companies are not just working to get back to normal, but are investing in the lessons they’ve learned through the pandemic will improve cancer care looking forward, she says.