Monitoring Advances Including Consent; Learning from COVID-19 Trials and Other Trials Running in UKCRC Registered Clinical Trials Units During the COVID-19 Pandemic

Abstract

BackgroundThe COVID-19 pandemic has affected how clinical trials are managed, both within existing portfolios and for the rapidly developed COVID-19 trials. Sponsors or delegated organisations responsible for monitoring trials have needed to consider and implement alternative ways of working due to the national infection risk necessitating restricted movement of staff and public, reduced clinical staff resource as research staff moved to clinical areas, and amended working arrangements for sponsor and sponsor delegates as staff moved to working from home. Organisations have often worked in isolation to fast track mitigations required for the conduct of clinical trials during the pandemic; this paper describes many of the learnings from a group of monitoring leads based in UKCRC Clinical Trials Unit (CTUs) within the UK.MethodsThe UKCRC Monitoring Task and Finish Group comprising monitoring leads from 9 CTUs, met repeatedly to identify how COVID-19 had affected clinical trial monitoring. Informed consent is included as a specific issue within this paper, as review of completed consent documentation is often required within trial monitoring plans (TMPs). Monitoring is defined as involving on-site monitoring, central monitoring or/and remote monitoring. ResultsMonitoring, required to protect the safety of the patients, the integrity of the trial and ensure the protocol is followed, is often best done by a combination of central, remote and on-site monitoring. However, if on-site monitoring is not possible, workable solutions can be found using only central or central and remote monitoring. eConsent, consent by a third person, or via remote means is plausible. Minimising datasets to the critical data reduces workload for sites and CTU staff. Home working caused by COVID-19 has made electronic trial master files (TMF’s) more inviting. Allowing sites to book and attend protocol training at a time convenient to them has been successful and worth pursuing for trials with many sites in the future.ConclusionsThe arrival of COVID-19 in the UK has forced consideration of and changes to how clinical trials are conducted in relation to monitoring. Some developed practices will be useful in other pandemics and others should be incorporated into regular use.

Making a distinction between data cleaning and central monitoring in clinical trials

“…It involves an evaluation of accumulating data (or lack thereof), performed in a timely manner and supported by appropriately qualified and trained persons. 7 This central monitoring is followed by escalation to an on-site monitoring visit, if concerns about a site warrant it. Some element of source data verification may be mandated, but often only for a small selection of data or participants.…”