What Happened to Clinical Trial Quality During COVID-19
Friends of Cancer Research shared on LinkedIn about a recent paper by Joseph M. Unger et al. published in JCO Oncology Advances:
“What happened to clinical trial quality when flexibilities like remote consent and drug delivery were introduced during COVID-19?
Findings from a joint task force by Friends of Cancer Research and American Society of Clinical Oncology (ASCO) reveal that reported protocol deviations, dropouts, and severe toxicity decreased when trial flexibilities were implemented during the COVID-19 pandemic.
Data from 67 trials involving 12,000 participants showed improvement in quality metrics during the pandemic’s initial wave. Even when patterns returned to pre-COVID levels in 2021-2022, they didn’t exceed baseline—despite widespread adoption of measures such as remote drug distribution, remote monitoring, and remote consent.
These results suggest decentralized trial elements can be implemented without compromising data quality. Broader adoption of these flexibilities would represent a paradigm shift that could dramatically improve access and enable more rapid, diverse enrollment.
Read the full study in JCO Journals Oncology Advances.”
Title: Impact of the COVID-19 Pandemic Mitigation Strategies on Cancer Treatment Trials: A Meta-Analysis of Industry and National Cancer Institute Studies
Authors: Joseph M. Unger, Hillary S. Andrews, Laura A. Levit, Brittany A. McKelvey, Mark Stewart, Beverly Canin, Keith Flaherty, Denise Kimball, Therica Miller, Adedayo Onitilo, Suanna Bruinooge, Elizabeth Garrett-Mayer, Caroline Schenkel.
Robin Zon, President at American Society of Clinical Oncology (ASCO), shared Friends of Cancer Research’s post on LinkedIn:
“This is awesome news – and proves that decentralizing clinical trials will not compromise the integrity of the trial. This thereby will increase access to CT for patients in the community setting, inner city, underserved areas, as well as as in our rural sites of care. Kudos to the authors for sharing this data.”
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