In 2020, ASCO established the Steering Group on Cancer Care Delivery and Research in a Post-Pandemic Environment to evaluate the changes made in oncology care delivery, clinical research, and regulatory oversight in response to the COVID-19 pandemic as well as to make recommendations on how to proceed as the pandemic subsides. This group included two multidisciplinary task forces: The Research Task Force and the Cancer Care Delivery Task Force.
In December 2020, ASCO published its recommendations for adopting a broad set of reforms to improve patient access to high-quality cancer care and participation in clinical trials as well as how to address the pandemic’s devastating effects on both patients and the oncology workforce.1 Members of the Steering Group identified five goals for clinical cancer research and an additional five goals for cancer care delivery from the lessons learned from the COVID-19 experience.
Goals for Clinical Cancer Research
Ensure that clinical research is accessible, affordable, and equitable—According to the report, a positive consequence of the pandemic is that research procedures became more patient-centric. ASCO recommends continuing modifications, including remote or virtual consent with e-signatures; administration of study-related treatment at local facilities; conducting patient assessments, laboratory testing, and imaging by local centers; and limiting the collection of research-only biospecimens.
Design more pragmatic and efficient clinical trials—Interventional oncology trials should be streamlined to incorporate pragmatic and efficient design elements, such as application of PRECIS-2 (https://www.precis-2.org) to maximize learning from trial participants; increase the generalizability of research results; integrate trial procedures more easily into standard clinical workflows; and reduce trial costs.
Minimize administrative and regulatory burdens on research sites—To reduce barriers to clinical trial participation, ASCO recommends that regulators enable trial and site flexibility by simplifying, standardizing, and streamlining U.S. Food and Drug Administration (FDA) and sponsor or contract research organization requirements.
Recruit, retain, and support a well-trained clinical research workforce—ASCO recommends creating educational materials to encourage greater study participation by both patients and clinicians and improving reimbursement for the time that clinicians spend enrolling patients. In addition, to make research more resilient in future crises, ASCO suggests cross-training research teams to enable key functions of the trial to be led by various team members and, by continuing trial flexibility, adopted during the pandemic, for site selection, initiation, and data collection.
Promote appropriate oversight and review of clinical trial conduct and results—To increase clinical trial efficiency, ASCO recommends that institutional review boards increase the speed and productivity of their review without jeopardizing the safety of research participants. ASCO also suggests that FDA standards for new drug approvals balance the need to quickly bring drugs to market while maintaining safety standards. “Designing trials with clinically meaningful outcomes would increase the likelihood that new drugs yield improvements for patients that represent true clinical benefit,” wrote the report’s authors.
Goals for Cancer Care Delivery
Promote and protect equitable access to high-quality cancer care—ASCO is calling on government, provider organizations, and other cancer stakeholders to support enhanced data collection to understand the impact of COVID-19 on patients with cancer, including its effect on social determinants of health. In addition, the Society is recommending that policymakers enact laws preventing cuts to Medicaid and expanding coverage; ensuring accessibility to affordable and comprehensive insurance plans; enhancing grants and other supportive measures for oncology practices in underserved communities; and sustaining federal safety net programs.
Support safe delivery of high-quality care—To protect patient safety, ASCO is recommending that new baseline infection prevention and control standards be developed for chemotherapy delivery to mitigate transmission of infectious agents, such as the coronavirus; there is reliable access to personal protective equipment and future COVID vaccines; and home infusion of anticancer therapy be strictly limited to exceptional circumstances.
Advance policies to ensure oncology providers have sufficient resources to provide high-quality patient care—ASCO recommends that grants and loans to practices made during the pandemic be unrestricted and that specific funds be allocated to practices and institutions serving underserved communities; the U.S. Department of Health and Human Services (HHS) supports the stability of cancer care delivery by avoiding new proposals that could disrupt care delivery through the duration of the pandemic and recovery; and that HHS continue flexibilities in quality reporting across all programs for 2 years.
Recognize and address threats to clinician, provider, and patient well-being—ASCO suggests increased reimbursement for professional behavioral health support/clinical psychology, support groups, or psychiatric care for both patients and providers. In addition, ASCO is calling for an update on its assessment of the oncology workforce to determine the impact of COVID-19–related workplace changes on recruitment, retention, and retirement/exit of cancer care clinicians and other professional staff.
Improve patient access to high-quality cancer care via telemedicine—The pandemic has compounded persistent disparities in access to cancer care, according to the Road to Recovery Report: Learning From the COVID-19 Experience to Improve Clinical Research and Cancer Care. To increase access to and equity of high-quality care to all patients, ASCO recommends making expanded coverage for telemedicine visits permanent. ASCO is also calling on the Society to engage with other stakeholders to develop a public policy position on cross-stage licensure, coverage, and certification of providers using telemedicine; and to develop evidence-based telemedicine products to advance quality cancer care.
Howard A. “Skip” Burris, MD, FACP, FASCO
To learn more about ASCO’s goals for the oncology community’s recovery from the COVID-19 pandemic and how they may lead to more equitable cancer care for patients, The ASCO Post talked with Howard A. “Skip” Burris, MD, FACP, FASCO, Chairman of the Board, leader of ASCO’s Steering Group on Cancer Care Delivery and Research in a Post-Pandemic Environment, and senior author of the Road to Recovery Report. Dr. Burris is President, Clinical Operations, and Chief Medical Officer of Sarah Cannon, the Cancer Institute of HCA Healthcare.
Assessing the Impact of COVID-19 on the Oncology Community
Please talk about the overall impact the COVID-19 pandemic has had on cancer research and on the delivery of care. Do you envision its impact being long-lasting?
We are still trying to understand the impact of the COVID-19 pandemic on cancer care. While trials are open to enrollment and clinics are receiving patients, there is still hesitancy by trial participants to travel to clinical trial sites. Clinical trial accrual is getting better, but it has not fully recovered. It will take time.
In the clinic, we are already seeing an increasing number of women with more advanced breast cancer, as well as patients with advanced lung cancer. The data are early on the clinical care side. I think increasingly complete data will gradually be coming in to document the full extent of newly diagnosed late-stage cancers.
What is interesting to me is seeing patients with breast cancer who say they felt a mass or sensed something was wrong, but they couldn’t get an appointment with their primary care physician last spring and summer, and so were unable to undergo mammography screening. Being unable to get appointments is one real factor we are seeing. The impact of this pandemic on cancer will be long-lasting.
With regard to research, delays in completing trials and the impact of that extension will play out over the next few years. I’m more confident about being able to recover from the delays in research than patients being able to get their cancer screenings on schedule, which is preventing a key to success in cancer care: early diagnosis and treatment.
Using Technology to Improve Cancer Care
How has technology facilitated uninterrupted patient care during the COVID-19 pandemic? Will telemedicine become an integral part of cancer care in the future? How do you see the technology improving care for patients?
The technology for patients who have access to it has been very, very effective. There were older patients and vulnerable patients with comorbid conditions who we were more comfortable being seen by video conferencing and telemedicine than in person. A picture is worth a thousand words, so seeing patients, even over a computer screen, can give us a sense of how well they are doing, and it was great to have that check in.
Patients with breast cancer who were on oral therapies, on maintenance phases of treatment, or on later years of adjuvant therapy, for example, all did very well with telemedicine. It’s disappointing that we still have not seen the end of the pandemic, and we know patients are struggling with the ongoing crisis. However, telehealth has been very satisfying for many patients and it has decreased the volume of physical visits to the clinic.
“In the clinic, we are already seeing an increasing number of women with more advanced breast cancer, as well as patients with advanced lung cancer.”— Howard A. ‘Skip’ Burris III, MD
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It is imperative that telemedicine become a permanent way to take care of our patients without making them travel to the clinic as often as we did prior to the pandemic. I am hopeful we are going to have federal legislation that will support this technology across the country.
Although telemedicine has been crucial in connecting patients with their physicians during the pandemic and was expected to help close the disparity gaps in care for patients in rural communities, an analysis by Komodo Health of telehealth utilization based on billing claims has found that patient use of telemedicine was directly correlated to higher levels of household income.2 Among the recommendations in the Road to Recovery Report is increasing access to and equity of cancer care by making expanded coverage for telemedicine permanent. However, many low-income patients do not have access to a computer, smartphone, or high-speed broadband. It is important that this report can help close the digital divide for these patients.
We need to push for greater health equity for our patients. It has been readily apparent in our clinic that patients with a higher income and advanced education are more likely to have access to telemedicine. However, the broadband issue for people with low income is real and needs to be helped. ASCO can be part of the solution by advocating for all patients to have access to high-speed broadband and telemedicine.
Increasing Clinical Trial Participation
Among the positive consequences of the pandemic were changes to research procedures that benefited patients, including allowing patients to virtually consent to trials and receive study-related treatment at local facilities. How might a permanent change to clinical trial procedures lead to an increase in patient participation in cancer trials, especially among underrepresented patients, and improve study efficiency?
It is a credit to the FDA and the National Cancer Institute that they relaxed regulations and procedures in clinical trial participation while prioritizing the safety of trial participants and researchers during the pandemic. ASCO was equally supportive of the plan to relax some clinical trial requirements. The phrase I used regarding cancer clinical trials was: “stay safe but stay the course.” I was misquoted in some media reports that I was advocating for broad eligibility requirements to be relaxed, and there was very little of that. I was talking about protocol deviations, including parameter coding deviations due to COVID-19, and allowing lab procedures to be done locally and monitoring patients via telehealth.
This area is one in which underrepresented patients, elderly patients, patients living in rural communities, and single patients with young children could benefit from telehealth because some of the prepandemic regulations requiring patients to come to the trial site for follow-up visits probably are not necessary. I’ve always talked about the feasibility of relaxing some of the follow-up requirements after the first few cycles of treatment, when we know how well patients are tolerating the therapy.
When possible, investigational oral drugs were shipped to patients’ homes instead of having them travel to the trial site; having their lab work done in local facilities near their home, and utilizing telehealth services for some clinical trial procedures were real satisfiers for our patients. All of that enabled more patients to participate in clinical trials who might otherwise have declined.
Will these temporary changes be made permanent post-COVID?
I’m hopeful some of these research changes will become permanent, and I think trial sponsors would be supportive as well. There is the right leadership at the FDA and the National Cancer Institute to implement these types of advances and make these pandemic-related changes permanent.
We know that President Biden has a strong interest in cancer research, and I feel that, in 2021, we will be able to put some of these rule modifications into legislation that will be positive for everyone, especially patients. We simply need more patients to enroll in clinical trials to answer critical research questions and advance clinical care.
Developing New Strategies to Combat Workforce Burnout
How has the pandemic affected the oncology workforce and exacerbated physician burnout?
The physical and emotional toll on our workforce has been substantial and is even more than I would have anticipated. Sometimes, with a crisis like this, there is some rallying around the problem. This pandemic, however, has been a drain on oncology providers, both at work and at home. There has been no escaping the stress. We’ve seen the difficulties many of our staff at Sarah Cannon continue to experience—for example, having to virtually educate their children, worrying about not being able to be with elderly parents, and experiencing self-isolation. The stress has been substantial.
We have gone from providing a smile and hug to our patients, to wearing a mask and not being able to touch our patients during these times. The mood overall is worrisome to both our physicians and our patients.
“A picture is worth a thousand words, so seeing patients, even over a computer screen, can give us a sense of how well they are doing.”— Howard A. ‘Skip’ Burris III, MD
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Our workforce was stretched thin before the pandemic. It’s clear that the pandemic has accelerated provider burnout, forcing nurses out of the profession and some physicians into early retirement. The first encouragement I’ve seen since the pandemic began is the rollout of COVID-19 vaccines—a light at the end of the tunnel, so to speak.
ASCO is also committed to -developing new strategies to help prevent workforce burnout in the future.
Working Together to Ensure Access to High-Quality Cancer Care
How will ASCO work with regulators, pharma, and the Biden administration to drive the implementation of the recommendations outlined in the Road to Recovery Report to improve access to high-quality cancer care for all patients?
This report provides a roadmap of actions, both on the clinical trial and patient care side, that ASCO, Congress, the Biden administration, research sponsors, and other stakeholders can take to improve access to affordable and equitable cancer care and clinical research for patients. ASCO will continue to push forward these remedies, including safety nets for patients, such as Medicaid expansion as well as affordable and comprehensive insurance plans. We have to continue to work with legislators to make sure they understand the regulatory and financial burden on both patients and providers.
With regard to the clinical trial system, ASCO’s Survey on COVID-19 in Oncology Registry (www.asco.org/asco-coronovirus-information/coronavirus-registry/covid-19-registry-data-dashboard) is gathering a great deal of data on the severity of COVID-19 among patients with cancer who are currently on treatment or who have recently completed treatment and are cancer-free, as well as the pandemic’s impact on the delivery of cancer care and patient outcomes. These data will provide information that will make our clinical trial system more resilient, flexible, and accessible.
ASCO has a real role to play in helping push forward the key initiatives in the Road to Recovery Report, including: expanding telehealth, promoting centralized independent review board assessments of clinical trials, reducing the administrative burdens of clinical research, and underscoring the absolute need for equity health-care access for our patients.
When will ASCO release its findings from the Survey on COVID-19 in Oncology Registry?
We will have initial findings in the early part of 2021. There is already some information on the data collected so far from cancer institutions and oncology practices on the registry’s website, and our goal is to publish data quarterly. We have just submitted additional data from several hundred patients in the Sarah Cannon network, so the registry is a living database of real-time information to help inform treatment approaches for patients with the coronavirus. There is going to be a lot gained from the data collected in the registry, including how patients in different geographic parts of the country fared during the pandemic, especially those living in rural communities.
Importantly, we have to continue to work with oncology practices, federal agencies, and legislators to prepare for future crises and respond quickly to ongoing challenges and opportunities.
DISCLOSURE: Dr. Burris has served as a consultant or advisor to AstraZeneca, Bayer, Pfizer, Daiichi Sankyo, Forma Therapeutics, Celgene, Incyte, and Novartis and has received institutional research funding from Roche/Genentech, Bristol Myers Squibb, Incyte, AstraZeneca, MedImmune, MacroGenics, Novartis, Boehringer Ingelheim, Lilly, Seattle Genetics, Merck, Agios, Jounce Therapeutics, Modern Therapeutics, CytomX Therapeutics, GlaxoSmithKline, Verastem, Tesaro, BioMed Valley Discoveries, TG Therapeutics, Vertex, eFFECTOR Therapeutics, Janssen, Gilead Sciences, BioAtla, CicloMed, Harpoon Therapeutics, Arch, Arvinas, Revolution Medicines, Array BioPharma, Bayer, BIND Therapeutics, Kymab, miRNA Therapeutics, Pfizer, Takeda/Millennium, and Foundation Medicine.
REFERENCES
1. Pennell NA, Dillmon M, Levit LA, et al: American Society of Clinical Oncology Road to Recovery Report: Learning From the COVID-19 Experience to Improve Clinical Research and Cancer Care. J Clin Oncol 39:155-169, 2021.
2. Taggart C: Perspectives: Expanded use of telemedicine exposes stark socioeconomic disparity. Komodo Health, August 17, 2020. Available at http://www.komodohealth.com/insights/expanded-use-of-telemedicine-exposes-stark-socioeconomic-disparity. Accessed February 17, 2021.
