COVID-19 has dramatically impacted the overall management of clinical trials.
But the pandemic has also had an outsized impact on trials focusing on oncology, hindering the development of potential treatments for various forms of cancer in several different ways. Recruiting patients for oncology studies was extremely difficult even before the pandemic as less than 5% of people diagnosed with cancer participate in clinical trials.
COVID-19 has made these existing issues more challenging and has introduced new issues – however, despite the hurdles, COVID-19 has also revealed a number of solutions that can help oncology trials post pandemic. The challenges of recruitment
Patient recruitment and retention ranks at the top of the list of challenges that face the clinical trial industry even during the best of times. COVID-19 has made finding patients for clinical trials exponentially harder, especially for oncology studies, which rely on patients who are immunocompromised.
Even routine activities can be extremely dangerous right now for many who suffer from various forms of cancer. Going to a medical facility to participate in a clinical trial, even with safety protections and protocols in place, can be too dangerous for many with cancer to even consider.
New technologies that allow for virtual and hybrid trials make it possible for patients to enrol and stay enrolled in studies conducted from their homes. Even before a patient is eligible to consider a clinical trial, there is the issue of diagnosis. Doctors and medical facilities are looking to limit the number of visitors they have, and people are understandably scared to see a doctor.
Routine check-ups by family doctors and specialists have been placed on hold. This has resulted in the number of people being screened for cancer to drop precipitously. At the same time, patient recruitment for oncology trials begins with an initial diagnosis.
Less screening for cancer has further limited the number of patients recruited for oncology trials. Even more, sites that conduct clinical trials, like university hospital systems, have understandably prioritised using available space for research to find a vaccine or other treatments for COVID-19, placing other trials on the backburner.
Patient reimbursement helps patient recruitment and retention. It is a big effort for even a healthy patient to enrol and stay enrolled in a clinical trial. It is an incredible hardship for someone suffering with cancer, balancing the needs of participating in a trial that could lead to a life-saving treatment with the demands of everyday life.
Taking time off from work, finding someone to provide childcare, and the costs of transit to participate in a clinical trial that could be held hundreds of miles away are burdensome during the best of times.
Making sure participants are paid and reimbursed in a timely, if not immediate, manner helps immensely with recruitment and retention. This remains true for virtual studies as well, using micropayments to reimburse those who participate in trials at home in smaller amounts for their commitment, assisting them in being able and willing to continue with a trial.
The financial impact on oncology trials The financial impacts COVID-19 has had on the US healthcare industry have also wound their way into oncology trials. The pandemic forced numerous hospitals and healthcare systems to close entire departments and offices due to the concerns of viral spread, with many of these offices unable to return to practice.
According to a survey from the Physicians Foundation, 8% – or approximately 16,000 medical practices – have closed due to COVID-19, with another 4% planning to do so over the next 12 months. Further, over 40% of those surveyed have also reduced staff due to the pandemic.
These facilities, in many cases, also double as investigator sites for clinical trial studies. Our work in the field has shown that the best types of recruiters for oncology trials are those that come from smaller, community-based medical officers, where doctors regularly interact with patients who are considered more than just a string of characters and numerals entered into a database.
Sadly, these community-focused medical officers are the ones that have been hit the hardest during the pandemic. Payments between drug sponsors, CROs and investigator sites are often a confusing process rife with delays. Delayed payments can literally make or break the continued existence of a clinical trial investigator site at this moment in time.
If sites are suffering financially, it is safe and accurate to say that participants are encountering more financial barriers than ever before. Patients who do not have the financial means to travel to a clinical trial or pay out of pocket for costs incurred will likely be unable to continue their participation because of these hurdles. It is imperative to consider different patient groups across all demographics, racially, ethnically, geographically and socio-economically as well, to see who is affected further by financial hardship.
For example, those who live in rural populations can be disproportionately affected by the barriers that burden other patients. A site researcher with the Kansas University Medical Center shared that not only is travel a major issue for those living in rural areas, but also many rural patients may not even be able to realise the benefit of reimbursement if that reimbursement is produced through means like gifts cards or cheques, as stores and banks can be extremely limited.
Many of the small, community-minded health practices that do such a great job recruiting oncology patients rely on the additional revenue that clinical trial participation brings. These practices are already enduring a reduced number of patients due to the pandemic. And, in many cases, they are also facing increased costs as they must now purchase PPE and other products in order to treat these dwindling numbers of patients.
A delay in a payment to an investigator site like this can cause a major cash flow issue very quickly. And a shortage of cash can force a medical practice to have to make some very tough decisions about staffing levels, the types of services provided and even if staying afloat is still viable.
No matter the course a study follows, reducing the financial stressors that can come with participating in a clinical trial makes it possible for more people from all over the spectrum of accessibility to enrol.
COVID-19 has reshaped how oncology trials occur, however, the right solutions do exist to get them back on track and to make badly needed structural improvements that help sites stay financially sound and increase the numbers of patients who enrol in trials. All of this bodes well for oncology research as these fixes can help better outcomes for research, especially for people who need treatments for cancer.