Decentralized clinical trial elements can be safely adopted as permanent fixtures without substantial reductions in data quality or increased risk to research participants, according to a new study in the JCO Oncology Advances (JCOOA).
The study, “Impact of the COVID-19 pandemic mitigation strategies on cancer treatment trials: A meta-analysis of industry and NCI studies,” was conducted by the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research Task Force.
When COVID-19 began in early 2020, U.S. cancer clinical trials experienced a dramatic slowdown prompting federal health agencies to issue guidance allowing for greater flexibility in trial conduct. Among these flexibilities were amending trials to allow remote patient consent to participate, remote symptom monitoring, and distributing oral anticancer agents directly to trial patients.
To assess how these changes affected trial quality, the task force looked at data representing 12,000 U.S. cancer patients from 67 industry and NCI trials spanning four time periods: pre-COVID (2017–Feb. 2020), the initial wave (Mar.–Apr. 2020), initial recovery (May–Dec. 2020), and secondary recovery (2021–2022).
The researchers focused on four core quality indicators: enrollment rates, major protocol deviations, patient dropouts, and severe treatment-related adverse events. They found that enrollment odds dropped sharply (by 49%) during the initial pandemic wave but rebounded to pre-pandemic levels during the secondary recovery period in 2021-22.
They also saw the rates of protocol deviations, dropouts, and severe toxicity decrease during the initial wave. For example, major protocol deviations fell from 15.7% pre-COVID to 8.2% during the initial wave -a 58% reduction in the odds. These rates gradually returned to baseline levels by the secondary recovery period.
The data suggests that while the acute pandemic disrupted trial conduct, the procedural flexibilities implemented were not associated with long-term reductions in data integrity and may have helped sponsors maintain trial momentum during an unprecedented crisis.
“The pandemic created a natural experiment that allowed us to study decentralized trial processes at scale,” said the study’s lead author, Joseph Unger, PhD, at Fred Hutch Cancer Center and the SWOG Statistics and Data Management Center. “What we found is encouraging: key trial quality metrics did not deteriorate, even as trials relied more heavily on remote and flexible procedures.”
Dr. Unger and the authors said they hope the findings will pave the way for broader adoption of DCT elements in oncological research.
“Making trials more accessible, especially to patients in rural areas or those facing logistical barriers, has long been a goal in oncology,” Dr. Unger said. “We believe this study confirms that decentralized elements can be implemented without compromising the integrity of cancer clinical trials and that the methods used will help reduce patient burden and open doors to more diverse populations in trials.”
Read the full study in JCOOA. The analysis in this study is the second phase of the ASCO ASCO) and Friends of Cancer Research Task Force. The first phase was a survey of industry representatives about their perspectives on the impact of trial flexibilities on trial protocols and data quality. Both studies were informed by ASCO’s Road to Recovery report that evaluated the impact of changes made to studies during the COVID pandemic.
ASCO has long supported improving access to patient-focused, decentralized clinical trials. For more information, read these ASCO statements: A call to action to advance patient‐focused and decentralized clinical trials and Improving Access to Patient-Focused, Decentralized Clinical Trials Requires Streamlined Regulatory Requirements.
