Innovation in Cancer Care and Cancer Research in the Context of the COVID-19 Pandemic Proceedings of a Workshop (2022) / Chapter Skim
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Proceedings of a Workshop
Proceedings of a Workshop
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To facilitate these efforts, health care regulators and payers rapidly made adjustments to help adapt cancer care and cancer research to meet the evolving needs across the health care and research enterprises. Pharmaceutical companies shifted their priorities to develop vaccines and therapeutics for COVID-19, while adapting their ongoing drug development operations to advance progress in oncology care and other disease areas.
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(Pierce) • The disproportionate impacts of the pandemic on marginalized communities amplified existing health disparities and highlighted the urgent need to improve equity in cancer care and clinical trials.
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• The pandemic ushered in a rapid, unprecedented industry-wide adoption of data collection methods and analytic approaches for clinical cancer research. (Melhem)
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• Improve the flexibility, speed, and effectiveness of cancer clinical trials while ensuring patient safety and scientific integrity. (Berger, Hyer, Levy, Lowy, Melhem, Perlmutter, Zon)
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Embracing a Broader Array of Trial Designs and Research Methods • Retain the positive changes made to cancer clinical trials in response to the pandemic. (Agrawal, Califf, Kluetz, Lowy, Perlmut ter, Pierce, Schilsky)
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Also, a number of speakers said the rapid and widespread adoption of telehealth was among the most dramatic changes in cancer care during the COVID-19 pandemic. As health care systems and clinical trials restricted in-person visits to protect patients and staff, many adopted video or audio calls for live, virtual clinician–patient encounters, as well as in-home health monitoring tools and technologies for asynchronous interactions.
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Nationally, Oyer noted that the Association of Community Cancer Centers created a community-focused national educational initiative for cancer care during the COVID-19 pandemic that offered webcasts, podcasts, and a peer forum to share up-to-date information on topics such as infection control measures, risk stratification for patients with cancer during the pandemic, COVID-19 testing strategies, staffing and care coordination, and modifications to cancer treatment protocols. Steven Pergam, associate professor in the Vaccine and Infectious Diseases Division at the Fred Hutchinson Cancer Center and medical director of infection prevention at the Seattle Cancer Care Alliance, provided a health system perspective on cancer care delivery during the pandemic.
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Knudsen noted that surgical oncology procedures and clinical trials with curative intent were considered "essential" and allowed to continue. The use of telehealth -- which was in place prior to the pandemic -- was escalated, and the cancer center provided backup oncology care capacity if community practices were unable to deliver care.
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She said the enterprise dashboard for virtual care prominently features statistics on access to virtual care by race and ethnicity, helping the organization to monitor patients' virtual and in-person experiences and to address identified disparities. In addition, the institution implemented a number of interventions aimed at improving health equity, such as employing digital access coordinators, offering multiple language options, and loaning devices to patients to enable telehealth connections.
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, discussed results from NCCS surveys that asked cancer survivors for their experiences with care delivery during the pandemic. First, Fuld Nasso said that the Telehealth Project solicited input from 29 patients on their experience using telehealth via focus groups in May and June 2020.
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She added that CMS is also evaluating how altered care patterns and delayed cancer screenings will affect patient outcomes and post-pandemic cancer care delivery. Bhuvana Sagar, a national medical executive at Cigna, said there was a dramatic decrease in the use of cancer screening during the early months of the pandemic.
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Additionally, regulatory changes provided temporary relief from many audit and quality reporting requirements so that care providers, health care facilities, Medicare Advantage health plans, Part D prescription drug plans, and states could focus on providing needed care to Medicare and Medicaid beneficiaries affected by COVID-19. SOURCES: Strawbridge presentation, July 26, 2021; https://www.cms.gov/files/document/covid-flexibilities-overview-graphic.pdf (accessed November 1, 2021)
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and international cancer centers, health systems, and hospitals quickly formed the COVID-19 and Cancer Consortium, whose goal is to collect data about patients with cancer who have been diagnosed with COVID-19 (Warner et al., 2020)
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Robert Winn, director of the Virginia Commonwealth University Massey Cancer Center and professor of pulmonary disease and critical care medicine at Virginia Commonwealth University, emphasized that the inclusion of community voices is critical to effectively respond to the public health emergency created by the pandemic. "The reality is people don't really care how much you know until they know that you care," Winn said, and stressed that the onus is on cancer centers and health care organizations to earn community trust, which requires the establishment of long-term, sustained relationships with communities.
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ADVANCING CANCER CARE DELIVERY IN A POST-PANDEMIC ERA Many workshop participants discussed potential opportunities to improve care delivery and clinical cancer research in the post-pandemic era. Some speakers stressed the importance of improving patient access to care by enhancing the use of telehealth and other digital tools, redesigning payment models, and ensuring cancer center–level expertise is accessible to patients and clinicians in rural and underserved settings of care.
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Pierce said ASCO encourages community-based, real-world interventions that incorporate an understanding of the social determinants of health, and has developed Telemedicine Standards to improve access to cancer care and cancer clinical trials for vulnerable populations (Patel et al., 2020)
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. She said the ASCO Expert Panel on Telehealth, which she co-chairs, is developing recommendations for optimal strategies for telehealth in oncology, including issues such as when it is preferable to see patients in person versus via telehealth; implementation considerations for telehealth in the oncology setting; roles for advanced-practice providers and allied health professionals; virtual multidisciplinary cancer conferences; and the use of telehealth in cancer clinical trials.
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Paul Jacobsen, associate director of the NCI Healthcare Delivery Research Program, pointed out that this model has been used successfully to provide mental health care, where a centrally located psychiatrist works with multiple clinicians to manage medications and monitor treatment adherence. Lennes suggested that equipping patients with wearable technologies and conducting both telehealth and in-person visits could offer exciting opportunities to improve patient care and outcomes.
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Michael McNeely, director of the Health Resources and Services Administration's (HRSA's) Office for the Advancement of Telehealth within the Federal Office of Rural Health Policy, said telehealth offers many benefits for patients, clinicians, and payers by providing much-needed access to care for rural and underserved populations, reducing care disruptions during public health emergencies, and serving as a cost-effective alternative to traditional in-person care delivery.
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Zon said that audio-only telehealth services were critical for individuals who lacked reliable Internet access -- and proved particularly helpful for serving rural patients or those with transportation barriers to receiving care. Lennes agreed that audio-only services are important for increasing patient access, especially among underserved populations, and suggested that payment parity for these interactions should be continued.
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She explained that these health disparities will not be easy to solve, but building resilience into recovery, engaging communities, and committing to an antiracist, multipronged, equitable strategy can enhance access to clinical trials, prioritize representation in health care and health care leadership, and improve health outcomes for all populations. Nunez-Smith said strategies to achieve these goals must be rooted in deep community engagement, strong partnerships, and an acknowledgment of the harms of structural racism, both in medicine and in society.
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or participate in clinical trials. To address these ongoing challenges, Lathan stressed that cancer centers and NCI need to work together to encourage new interventions to promote health equity (Bruno et al., 2021; Doykos et al., 2021; Robert et al., 2021)
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Lathan noted that integrating patient navigation, education, and outreach is an example of low-hanging fruit that can benefit communities. Winkfield agreed, adding that expanding patient navigation staff, perhaps to include trusted community members, and ensuring reimbursement for patient navigation would improve care access, clinical trial enrollment, and patient satisfaction.
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This lack of true community connection and engagement, along with inadequate health care access, structural inequities, racism, and bias, contribute to disparities in cancer care delivery and health outcomes. Chambers and Winkfield agreed that cancer centers historically have not meaningfully engaged with the communities they serve.
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Prior to the pandemic, clinical trials were conducted primarily in academic settings of care and designed to answer questions of interest to clinical investigators; however, she said there is increasing interest in experimenting with more distributed trial designs that answer treatment-related questions that are important to patients. Adapting Clinical Cancer Research Mia Levy, the Sheba Foundation Director at Rush University Cancer Center and system vice president of Cancer Services at Rush System for Health,12 described three overarching phases of clinical cancer research during the pandemic: (1)
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Another major challenge moving forward is a workforce shortage for clinical cancer research, which Levy speculated will negatively affect patient enrollment in clinical trials. The pandemic illustrated that "rapid change is possible in clinical research," which had not previously been demonstrated, given the historically slow-moving, heavily regulated nature of clinical research, Levy said.
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. Kelley said that telehealth has the potential to improve clinical cancer research because it can help to lower costs, increase patient recruitment and retention rates, improve diversity, generate more data from integrated digital tools, and improve the applicability of research by involving participants who are more representative of the general population (Khozin and Coravos, 2019)
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However, Sacks said it will be important to develop specifications for technologies to ensure the quality and reliability of data from digital health technologies used in different settings. Adjustments to Federal Policies and Guidelines for Cancer Research James Doroshow, director of the Division of Cancer Treatment and Diagnosis and deputy director for clinical and translational research at NCI, discussed the impacts of the pandemic on NCI-supported clinical trials.
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Doroshow said that NCI is in the process of developing the NCI Clinical Trials 2030 Strategic Plan, with a focus on streamlining clinical trials, distributing clinical trial activities, and improving patient access to clinical trials, especially among underrepresented and underserved populations. Sundeep Agrawal, acting team lead for genitourinary malignancies at CDER and clinical lead of Project Renewal at the Oncology Center of Excellence (OCE)
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Industry-Sponsored Clinical Trials Dietmar Berger, chief medical officer and global head of development at Sanofi, spoke on behalf of TransCelerate.15 He highlighted the pandemic had a catalyzing effect on the pharmaceutical industry because it forced a reconsideration of opportunities to improve clinical trial conduct, not only during the crisis of the pandemic, but also in the future. TransCelerate's sponsor organizations convened the Modernization of Clinical Trial Conduct Initiative, which identified several key challenges to advancing progress in clinical trial conduct: (1)
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He said the pandemic did slow recruitment for BMS clinical trials, with some studies needing to be completely halted. However, BMS made a number of changes to the conduct of their clinical trials, including leveraging new technologies for remote monitoring, encouraging patient–investigator virtual visits when data could be collected by telephone or video call, exploring central monitoring capabilities and virtual site inspections to minimize nonessential travel, allowing trial participants to visit alternative clinical centers, and direct-to-patient shipments of investigational drugs.
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Berger emphasized that a major barrier to progress is the lack of global regulatory harmonization, which results in a patchwork of regulatory requirements for cancer clinical trials that could limit the adoption of innovations. 16 An external control arm "consists of patients who are not part of the same randomized study as the group receiving the investigational agent." See https://www.fda.gov/downloads/ guidances/ucm073139.pdf (accessed November 1, 2021)
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Data access and quality were important before the pandemic, but Ribas noted that rapid changes to the conduct of clinical trials brought these issues into even greater prominence. Levy agreed, and added that the pandemic has provided the motivation to enable greater access to patients' full medical information.
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Oncology EHRs, for example, focus on cancer treatments, but oncology outcomes can also be influenced by other conditions, such as COVID-19. Paul Kluetz, deputy director of FDA OCE, said that to advance evidence generation and decision making from real-world data, FDA has created an oncology-specific, real-world evidence program that aims to develop consistent terminology; standardize quality metrics for data from various sources; advance real-world endpoints, such as response rate, which are especially important in single-arm cohorts; and support collaborations with the broader cancer community and data ecosystems to improve data quality and interoperability (FDA OCE, 2021b)
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While there are barriers, such as a lack of foundational definitions, methods, data characterization and quality, and understanding of biases, she noted that FDA OCE is open to novel study design and evidence generation strategies to improve patient care and outcomes. The Future Role of Telehealth and Other Modifications in Cancer Clinical Trials Several speakers suggested that the expanded use of telehealth has been a positive development in cancer clinical trials and suggested further expansion of its use after the pandemic as part of a broader move toward decentralization of cancer clinical trials.
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He suggested future efforts need to focus on maximizing data quality, creating best practices for the study modifications that benefit patients most, and determining how these data can best inform regulatory decision making. Sources of evidence are expanding, and there is a blurring of lines between traditional prospective clinical trials and data generated from routine clinical care, said Kluetz (see Figure 5)
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Schilsky noted that all trials have or could have some form of decentralization. He stressed that some of the centralized protocols in clinical trials are unnecessary.
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Lessons from the Development of COVID-19 Vaccines Randall Hyer, senior vice president of global medical affairs at Moderna, spoke about the Moderna COVID-19 vaccine development process and its relevance to cancer research. He said vaccine development was propelled forward by an overarching sense of urgency during the pandemic.
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Assessing the Positives and Negatives of Research Modifications Several speakers discussed which trial adaptations made in response to the COVID-19 pandemic, if made permanent, would have potential to improve the future of cancer clinical research and evidence generation. Kluetz said changes enacted during the pandemic showed that decentralizing aspects of clinical trials in oncology is feasible, and that it is now up to clinical investigators, patients, trial sponsors, and regulatory bodies to prioritize which modifications provide the most efficiency and benefit to patients with protecting patient safety and data integrity (Flaherty et al., 2021)
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The disproportionate impacts of the pandemic on marginalized communities amplified existing health disparities and highlighted the urgent need to improve equity in cancer care and clinical trials.
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New efficiencies in conducting clinical trials emerged, including rapid trial initiation, electronic consent, rapid approval of protocol changes, and increased use of remote assessments and community sites. Increased adoption of decentralized trial designs and telehealth technologies enabled many trials to increase enrollment diversity; novel study designs expanded data collection and opened opportunities to tap new sources; and new strategies were implemented to support data management, integrity, and quality.
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2021. Racial disparities in biomarker testing and clinical trial enrollment in non-small cell lung cancer (NSCLC)
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2021. FDA guidance on conduct of clinical trials of medical products during the COVID-19 public health emergency.
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2010. Optimizing collection of adverse event data in cancer clinical trials supporting supplemental indications.
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2020. COVID-19 and clinical trials: The Medidata perspective release 8.0.
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2020. Beyond COVID-19: Modernizing clinical trial conduct.
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2020. COVID-19 and readjusting clinical trials.
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