Since the United States’ first coronavirus case was confirmed in January 2020, COVID-19 has disrupted healthcare in myriad ways. Hospitals and healthcare practices trained their focus on acute care of infected patients. This has accelerated in recent months as a new surge in the pandemic has mounted.
General patient appointments and non-essential surgeries were delayed or reconsidered, and a new round infection is driving health systems to again revisit their process. Home visits and online consultations allowed some clinical trials of novel therapies to proceed, however many sponsors, research institutions and hospitals paused involvement in trials altogether.
Consider practices taking measures to protect patients today, designed to allow cancer patients to stay home as much as possible. Physicians are changing therapy regimens from intravenous treatments to oral doses whenever appropriate, for instance. This means treatment options that may be part of clinical trials may be taken off the table.
This is concerning, given clinical research is obviously the only way cutting-edge therapies are approved and introduced to market. Yet even before the pandemic, less than 14% of all clinical trials completed on time. Approximately 50% of clinical trials didn’t meet enrollment goals. And only 5% of cancer patients were enrolled in clinical research.
With the American Cancer Society predicting more than 1.8 million new cancer diagnoses in 2020, it’s not enough to get derailed oncology clinical trials back on track. We can do better, and here’s how.
Make a Collective Push to Collect Data
Despite the pandemic, we can expect major research hospitals to continue connecting cancer patients with cutting-edge treatment options. Smaller hospitals may not feel they have the financial security or bandwidth to become further engaged with clinical trials just yet. Know that oncology clinical trials aren’t like other trials.
A patient in a small town may have the key biomarkers that meet the precise standards of a hard-to-enroll trial. If more medical centers, community oncology practices, and integrated delivery networks would invest in technology to aggregate and analyze patient data, we could fast track connections between new therapies and the patients who need them, no matter where they live.
Not Just More Data, The Right Data
Electronic medical and health 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. When cancer center staff try to ascertain if patients matching inclusion requirements for a clinical trial are in their practice, they often spend hours manually reviewing unstructured data from sources such as physician notes and lab and pathology reports.
This effort is necessary regardless of how well they know their patients. It is necessary because trial criteria is a complex combination of disease, stage, morphology, lab, genomic, and molecular data points. 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 the practice’s researchers.
Talk About Telehealth
Among the many lessons 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 at the beginning of the year can be overcome with two cameras and a user-friendly computer interface.
Practice networks are exploring solutions like Doxy.Me to take as many appointments virtual as possible. Physicians can email or text a secure link. Patients can then connect via a mobile or desktop device to have important conversations and check-ins.
There is an opportunity to explore home-based treatment. With better reimbursement for home-based infusions for cancer drugs and clinical trial drugs more options become available for patients and providers. A home infusion nurse could help with gathering key data points for a clinical trial and adding to the body of real world data that can inform insights.
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. For healthcare administrators who serve as a bridge between the clinical and research worlds, now is the time to start a dialogue with hospital research directors, administrators and physicians about how telehealth and electronic collaboration could change the game around clinical trials.
Make a Plan
Many are hopeful that elements of FDA COVID-19 changes and accommodations will remain in place permanently. 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. If we sincerely care about changing cancer outcomes, we should never treat clinical research as non-essential. Without targeted therapy options, providers may fall back to prescribing legacy cytotoxic treatments, such radiation and chemotherapy. And after all, the experimental treatment of today could become the essential treatment of tomorrow.
Marie E. Lamont is President and COO of Inteliquet, a patient matching software company for clinical trials. Before Inteliquet, Lamont was President of the patient services business unit of Dohmen Life Science Services, and previous to this global head of business strategy and commercial operations for rare diseases at Genzyme. She can be reached at firstname.lastname@example.org.