A risk-based approach to experimental early phase clinical trials during the COVID-19 pandemic


Experimental cancer medicine has evolved over the past decade, with increasing trial complexity and operational demands. As a dedicated phase 1 trials unit, we are used to change and uncertainty, and exploring new ways to improve our processes. However, the arrival of coronavirus disease 2019 (COVID-19) has caused an upheaval in health-care services. On March 23, 2020, the UK went into lockdown. In this Perspectives piece, we reflect on the extraordinary reshaping of delivery of patient care in our experimental phase 1 cancer clinical trials unit.

Risk–benefit and safety in early clinical trials during the pandemic

Patient safety is the prime objective of early phase trials, which might need to be ranked on the basis of their risk–benefit profile (figure). Drug development clinicians weigh up potential benefit from novel drugs against toxicity risk, while adhering to complex protocols to ensure accurate data collection pertaining to trial-specific endpoints. The weighing of potential benefit against risk is the cornerstone of translation of preclinical discoveries into the clinic, while ensuring compliance with Good Clinical Practice. When initial reports suggested that patients with cancer were at increased risk of COVID-19 morbidity and mortality, it was imperative that they would be shielded to reduce exposure. As one of the largest oncology phase 1 trials unit in Europe, treating more than 300 new patients on nearly 60 actively recruiting trials per year, we had to employ risk management strategies to safeguard patient safety while ensuring integrity of trial conduct. We made the unprecedented, but necessary, decision to temporarily halt recruitment onto cancer clinical trials nationally in light of concerns regarding intensive-care bed availability.
A risk-based approach to experimental early phase clinical trials during the COVID-19 pandemic - D'Olhos Hospital Dia