ABSTRACT
Aims: The COVID-19 pandemic substantially disrupted healthcare globally. Quarantine, travel restrictions, health worker furloughs and institutional mandates to limit non-essential clinical activity significantly impacted upon trials recruitment abroad. The purpose of this review was to compare the demographics and enrolment for patients referred to The Kinghorn Cancer Centre (TKCC) Phase 1 Unit between January 2020 and March 2022, with historical data from the same institution from the twelve months prior to determine the impact of COVID-19 on Phase 1 activity. Method(s): A single institutional retrospective study was performed utilising a purpose-built Phase 1 database. Data extracted from electronic medical records and trials electronic data capture software included patient demographics, date and method of first review, consent date, screen-failure rate, date to enrolment, duration on trial and outcome post-trial. Analyses were performed in SPSS V26.0. Result(s): Four hundred and thirty-four patients were referred/seen in the Phase 1 unit between January 2020 and March 2022 (16/month), of which 341 (79%) were consented/screened onto a Phase 1 trial and 157 (46%) proceeded to treatment. The proportion initial consultations using telehealth increased from 11.3% to 45.3% pre-post pandemic (P < 0.0001). However, the proportion of interstate referrals or regional/remote referrals did not change likely to widespread increase in telehealth utilisation. Pandemic-induced lockdowns decreased absolute numbers of Phase 1 referrals in the short term, however did not influence enrolment or screen failure rates. Further mitigation strategies successfully employed at our Phase 1 unit included treatment-athome, teleconsenting, Phase 1 coordinators/investigators working in split teams, and remote monitoring. Conclusion(s): The COVID-19 pandemic did not impact upon the demographics of Phase 1 referrals to a major metropolitan hospital, however absolute numbers of referrals were influenced by lockdowns/ outbreaks. Telehealth was successful at maintaining access to trials for patients in need and should be continued to allow equity of access to Phase 1 trials.