Early-phase clinical trials in the pandemic era: a four-year experience from an academic cancer center.

Abstract

Early-phase clinical trials are the first step in cancer drug development. However, they are becoming difficult to conduct - increased complexity of treatments, multiple stakeholders, and most importantly, the changes imposed by the COVID19 pandemic. We report our experience during and since the pandemic, focusing on early-phase clinical trials for solid tumors. From 2020-2023, our accruals improved by 161% (from 33 to 86). We consented 260 patients; of those, 176 (68%) fulfilled all eligibility criteria and started therapy - trials included immunotherapy (74, 42%), targeted therapy (43, 24%), novel molecules (30, 17%), cellular therapy/oncolytic viruses (19, 11%), and pharmacokinetic assessment trials of standard therapies (10, 6%). We increased staffing from 4 to 12 over this period, instituted hybrid work policies, created a dedicated triage nurse to reduce screen failures, and developed disease-specific sub-teams for better efficiencies and lower error rates. These efforts allowed us to improve the quantity and quality of our accruals.