Implications for design and analyses of oncology clinical trials during the COVID-19 pandemic.
Abstract
mation on alternative therapies.Shared decision-making needs to be a component of our standards.Finally, we need to address and eliminate inequities in care.Health care is migrating from a fee-for-service model to a value-based or shared-risk model of reimbursement; our metrics and incentives should also be value based.It is time for standards of cancer care to include patient experience and cost in addition to traditional quality metrics.Societies that have a stake in breast cancer care have an opportunity to partner with each other and with patients to create holistic value-based guidelines that, if embraced, will further improve cancer care.The American College of Surgeons' quality and cancer programs are currently developing value-based metrics.The NAPBC has representation from all disciplines, including patient advocacy groups, and is well suited to lead this effort.There is no need to wait for a cure for many patients with breast cancer at our institutions.We have the cure, if we work together with those we serve.
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The UK Medicines and Healthcare Products Regulatory Agency set guidance for trial investigators to assess the risks and benefits of ongoing trials during COVID-19 and to consider options including halting recruitment, adapting delivery processes, stopping or suspending the trial, or mitigating risks as the trial proceeds.
“For example, the UK Medicines and Healthcare Products Regulatory Agency set guidance for trial investigators to assess the risks and benefits of ongoing trials during COVID-19 and to consider options including halting recruitment, adapting delivery processes, stopping or suspending the trial, or mitigating risks as the trial proceeds.”
Cites
Klein, J. P., & Moeschberger, M. L. (2003) · Statistics for biology and health · doi:10.1007/b97377 · Cited by 1,832 · see citing works
Preserving Clinical Trial Integrity During the Coronavirus Pandemic
McDermott, M. M., & Newman, A. B. (2020) · JAMA · doi:10.1001/jama.2020.4689 · Cited by 193 · see citing works
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Orkin, A. M., Gill, P. J., Ghersi, D., Campbell, L., Sugarman, J., Emsley, R., Steg, P. G., Weijer, C., Simes, J., Rombey, T., et al. (2021) · JAMA · doi:10.1001/jama.2021.9941 · Cited by 299 · see citing works
- Authors
- Moskowitz, C. S., & Panageas, K. S.
- Affiliations
- Memorial Sloan Kettering Cancer Center (US)
- Corresponding author
- Moskowitz, Chaya S.
- Venue
- JAMA Oncology
- Publisher
- American Medical Association (AMA)
- Published
- 2020-09-01
- Volume
- 6
- Issue
- 9
- Pages
- 1326
- ISSN
- 2374-2437 (ISSN-L)
- OpenAlex
- W3036175030
- Cited by
- 11
- References
- 2
- Citations by year
- 2024: 1 · 2023: 1 · 2022: 1 · 2021: 6 · 2020: 2
- FWCI
- 0.91
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA Oncology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Oncology › COVID-19 and healthcare impacts
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
- Keywords
- COVID-19 pandemic, cancer clinical trials, clinical trial design, shared decision-making, health care inequities, value-based payment, breast cancer care, quality metrics, patient experience, cancer treatment costs, American College of Surgeons
- MeSH terms
- Betacoronavirus, COVID-19, SARS-CoV-2, Clinical Trials as Topic, Humans, Medical Oncology, Neoplasms, Pneumonia, Viral, Coronavirus Infections, Pandemics
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