Managing oncology clinical trials during COVID-19 pandemic
Open accessAbstract
São Paulo city is the epicenter of the Brazilian COVID-19 pandemic. The Instituto do Cancer do Estado de São Paulo is currently conducting 161 multinational sponsored trials plus 116 in house studies in the oncologic population. There are 242 currently active participants and 180 patients in follow-up. The management of the tightly controlled environment of clinical research becomes a challenge, and the Food and Drug Administration set of priority recommendations for patient safety while maintaining study integrity. Fast adaptations are necessary, and actions coalesce to participant protection from COVID-19. We pointed out critical processes for adjustments, and we believe that our experience may help other academic health centers.
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Editorials have called on trial authors to describe pandemic-related issues in the methods sections of articles, including changes in study protocol, trial delays or interruptions, issues with missing data, and effects on statistical power.
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Rapidly Converting to “Virtual Practices”: Outpatient Care in the Era of Covid-19
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Data to guide the application of the new WHO criteria for releasing COVID-19 patients from isolation
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Self-citationBringing a humanistic approach to cancer clinical trials
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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
- Arai, R. J., Moniz, C. M. V., Chen, A. T. C., Mak, M. P., Chammas, R., & Hoff, P. M.
- Affiliations
- Instituto do Câncer do Estado de São Paulo (BR)
- Corresponding author
- Arai, Roberto J.
- Venue
- Contemporary Clinical Trials Communications
- Publisher
- Elsevier BV
- Published
- 2020-09
- Volume
- 19
- Pages
- 100637
- ISSN
- 2451-8654 (ISSN-L)
- PMC
- PMC7424329
- OpenAlex
- W3048440864
- Cited by
- 18
- References
- 7
- Citations by year
- 2024: 1 · 2023: 1 · 2022: 3 · 2021: 6 · 2020: 7
- FWCI
- 1.54
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Contemporary Clinical Trials Communications (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Medicine › Oncology › COVID-19 and healthcare impacts
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Social Sciences › Education › Education during COVID-19 pandemic
- Keywords
- COVID-19 pandemic, cancer clinical trials, clinical trial management, participant safety, academic medical centers, São Paulo
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