Considerations for conducting phase 1 trials in COVID-19 era proposed
medwireNews: A French team has put forward preliminary guidance for conducting phase 1 oncology clinical trials during the COVID-19 pandemic, including specific precautions for managing any participants with SARS-CoV-2.
“Considering the current absence of clinical data in this field, these reflections are based on our Phase 1 experience only and are deemed to evolve and be enriched at a wider and international level in order to serve for the establishment of evidence-based guidelines,” say Sophie Postel-Vinay and colleagues from Institut Gustave Roussy in Villejuif in the European Journal of Cancer.
They address key issues in the management of participants with COVID-19, such as the need to “thoroughly” consider the safety profile of the investigational drug to rule out potential interactions with the course of infection and adjustments (eg, teleconsultations) to allow patients to remain on trial if deemed feasible.
Postel-Vinay et al also stress the importance of toxicity causality assessments, especially during the dose-escalation phase of trials, as inadequate assessments “could lead to wrongly halting the drug’s dose-escalation, which may have deleterious and irreversible consequences for subsequent drug development.”
Finally, the authors touch on the issue of clinical research priorities for patients with cancer and COVID-19, suggesting that perhaps inclusion in a COVID-19 treatment trial should be favored in light of the urgent need to identify “efficient therapeutic strategies,” unless there is strong rationale supporting recruitment to an oncology trial.
medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group
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