A new meta-analysis published in JCO Oncology Advances by Friends of Cancer Research (Friends) and the American Society of Clinical Oncology (ASCO) finds that flexibilities implemented in cancer clinical trials during the COVID-19 pandemic did not compromise data quality. These findings support the broader adoption of decentralized trial elements to improve access and representativeness across patient populations.
The analysis included 67 cancer trials representing 12,000 patients with multiple cancer types—including prostate, breast, bladder, myeloma, lymphoma, and lung cancers—and compared trial quality metrics over four time periods: pre-COVID-19 pandemic, during the initial pandemic wave, and through two recovery periods.
Results showed that key proxies for trial quality, such as protocol deviations, patient dropouts, and severe toxicity rates, declined during the initial wave of the pandemic and returned to pre-pandemic levels during the recovery period. These findings suggest that remote consent, home delivery of medications, and other adaptive strategies did not adversely affect trial data quality.
Guidance issued in response to the pandemic, such as modifications to trial procedures, likely contributed to fewer events being classified as protocol deviations, such as missed visits. Logistical changes, such as direct shipment of study drugs to patients’ homes, may have also helped reduce protocol deviations. Additionally, survey data suggest that investigators and care teams adopted strategies to limit immunocompromising treatments early in the pandemic, which could have influenced the reporting of severe toxicities.
The study also examined how trial flexibilities impacted trial conduct in certain demographic subgroups. During the initial wave, Black patient enrollment dropped but rebounded during the recovery. Black patients and patients aged 65 and older showed a larger drop in reported protocol deviations.
While flexibilities in trial procedures had been studied and used prior to the COVID-19 pandemic, they had not been widely adopted due to data quality concerns. This new analysis provides evidence to suggest that such measures can maintain trial quality while improving accessibility.
Routine adoption of flexible trial procedures would represent a meaningful shift in cancer trial conduct, with the potential to improve access and representative patient participation.
Read the full analysis in ASCO’s JCO Oncology Advances: https://ascopubs.org/doi/full/10.1200/OA-25-00021
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Manuscript Authors
Joseph M. Unger, Hillary S. Andrews, Laura A. Levit, Brittany A. McKelvey, Mark Stewart, Keith Flaherty, Denise Kimball, Therica Miller, Adedayo Onitilo, Suanna Bruinooge, Elizabeth Garrett-Mayer, Caroline Schenkel.
Affiliations
Fred Hutchinson Cancer Center, Massachusetts General Hospital, Johnson & Johnson, Tisch Cancer Center, Marshfield Clinic Health System, Children’s National Hospital.
Acknowledgements
Data for this assessment was provided by nine commercial trial sponsors and one NCI cooperative group. We thank them for their partnership to evaluate the impact of trial flexibility on study conduct and data quality.
