UCLH has a large portfolio of over 200 active academic and industry sponsored clinical trials across all phases. The cancer trials take place in the Trust’s cancer hospital – UCH/Macmillan Cancer Centre, supported by a dedicated Cancer Clinical Trials Unit (CCTU), and in our National Institute for Health Research (NIHR) Clinical Research Facility (CRF).
As was the case in all NHS Trusts in the UK, the onset of the COVID-19 pandemic in March 2020 led to the pausing of large portfolios of clinical trials so that the NHS could urgently establish capacity for clinical care of Covid-19 patients.
The ability to rapidly switch to remote monitoring of industry clinical trials at UCLH enabled the Trust to keep open a portfolio of high priority studies, notably clinical trials involving patients with life-threatening conditions and trials where withdrawal of trial treatment would be considered harmful to patients.
UCLH continued to treat enrolled patients and in some cases continued to recruit new patients to cancer trials. Some of the studies in the UCLH portfolio already had in place approvals for remote monitoring; others quickly sought amendments which were speedily granted by sponsors and the MHRA.
UCLH’s electric health records system – Epic - enabled trials teams to grant access to all clinical trial patients’ records in a secure and compliant manner. Monitors were required to sign a code of conduct before being granted access to EpicCare Link (a specific URL) to access patients records remotely, once ‘released’ by UCLH study teams.
Trust policy prior to the pandemic was for monitors to have access for a 90-day period. This was extended to 365 days to further ensure access for monitors throughout the pandemic. The rapid roll out of Microsoft Teams enabled research teams at UCLH to meet with Clinical Research Associates (CRAs) and review data entry and data clarification forms (DCFs) together.
The ability to implement remote monitoring, allowing sponsors continued and timely safety and efficacy oversight, has been key to continuing patient activity through the pandemic at UCLH. It has become a priority for the UCLH CCTU which has routinely collected feedback following each routine monitoring visit and continued to do so for remote monitoring.
Data from this embedded evaluation show that there has been no negative impact on Principal Investigator-oversight, data quality, turnaround of DCF resolution or perceived availability of staff at all levels.
When asked about the ease of access and use of Epic for remote monitoring, 70% of respondents found the process Easy or Very Easy with the remaining 30% finding it Manageable (5-point scale; Very Difficult, Difficult, Manageable, Easy, Very Easy). The UCLH CCTU has also obtained qualitative feedback from CRAs which has been very positive as the comments below exemplify.
Marta Alonso Garcia-Maurino, MSD Representative, said: “MSD Clinical Research Associate (CRA) experiences of remote Source Data Verification (SDV) at UCLH have been fantastic. CRAs have commented that remote access to UCLH’s electronic medical records is straightforward and the system is user friendly and easy to navigate. Most source data is available within the system, enabling CRAs to rapidly catch up on SDV backlog and meet database lock timelines. This method of SDV is not too labour intensive for site staff, allowing them to focus on other clinical trial related activities including recruitment and supporting query resolution.”
Stuart Hatcher at healthcare company IQVIA, said: “At the start of the Pandemic UCLH were very quick to adapt and, by the end of March 2020, had developed a remote monitoring policy to give our CRAs here at IQVIA continued access to their electronic health records system Epic. This allowed us to have continued oversight of our trials within this Trust, which in turn helped keep us on track with timelines and maintain study oversight.”
