Procedural flexibility incorporated into many cancer clinical trials during the COVID-19 pandemic had no long-term negative effects on data quality, according to a meta-analysis. The use of decentralized trial elements did not lead to spikes in dropouts, major protocol deviations, or severe adverse events. These results suggest that sponsors and regulators should consider broader adoption of these strategies in oncology research. Joseph M. Unger, PhD, MS, professor in the cancer prevention program at Fred Hutch Cancer Center, and colleagues concluded that the fear of data quality suffering due to decentralized trial elements may be unfounded. This finding is promising for both patients and investigators, as decentralized approaches aim to make trial participation easier. The COVID-19 pandemic significantly disrupted clinical trials, leading to a reduction in trial activations and enrollment. Despite these challenges, the adoption of decentralized clinical trial strategies did not negatively impact data quality. Healio spoke with Unger and other oncologists about the implications of these findings, how decentralized clinical trials can expand patient access, and the barriers that must be overcome to ensure broader implementation.
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