Impact of the COVID-19 Pandemic Mitigation Strategies on Cancer Treatment Trials: A Meta-Analysis of Industry and National Cancer Institute Studies
In this multicollaborator evaluation, large declines in enrollment, major protocol deviations, dropouts, and severe toxicity during the acute phase of the pandemic all returned to pre-COVID-19 levels by 2021-2022. These findings highlight the impact of the temporary disruption to trial conduct during the pandemic's peak, but suggest that pandemic-related procedural flexibility did not result in long-term reduced data quality. Sponsors and regulators should consider broader adaptation of trial flexibilities moving forward.
Authors
- Keith T. Flaherty (ORCID: https://orcid.org/0000-0002-3402-0478)
- Elizabeth Garrett‐Mayer (ORCID: https://orcid.org/0000-0003-4709-0333)
- Suanna S. Bruinooge (ORCID: https://orcid.org/0000-0002-9936-2719)
- Therica M. Miller (ORCID: https://orcid.org/0000-0002-4086-3076)
- Mark Stewart (ORCID: https://orcid.org/0000-0002-4847-0736)
- Laura A. Levit (ORCID: https://orcid.org/0000-0001-9136-4229)
- Hillary S. Andrews (ORCID: https://orcid.org/0000-0002-0177-2024)
- Daniel B. Kimball
- Caroline Schenkel (ORCID: https://orcid.org/0000-0002-3613-8509)
- Beverly Canin (ORCID: https://orcid.org/0000-0001-7864-1121)
- Brittany A. McKelvey (ORCID: https://orcid.org/0000-0001-9239-7153)
- Joseph M. Unger (ORCID: https://orcid.org/0000-0002-5191-0317)
- Adedayo A. Onitilo (ORCID: https://orcid.org/0000-0001-9185-0606)
Institutions
- American Society of Clinical Oncology (US)
- Johnson & Johnson (United States) (US)
- Children's National (US)
- The King's College (US)
- Massachusetts General Hospital (US)
- Fred Hutch Cancer Center (US)
- Marshfield Clinic Weston Center (US)
- Tisch Hospital (US)
- Breast Cancer Options
- Tisch Cancer Institute
- Friends of Cancer Research (US)
Publication Details
- Journal
- JCO oncology advances.
- Published
- 2025-03-01
- DOI
- https://doi.org/10.1200/oa-25-00021
- Citations
- 3
- Primary Topic
- COVID-19 and healthcare impacts
- Type
- article
- Field-Weighted Citation Impact
- 3.14