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Barts Health brings its staff on the study restart journey

Barts Health brings its staff on the study restart journey

Empowering research delivery staff to make decisions about the eligibility, suitability of and their capacity to reopen studies has been key to Barts Health reopening a sizeable chunk of its non-COVID studies after the suspension caused by the pandemic.

“We’ve taken a pragmatic approach to reopening studies with decisions made at local level, because we wanted to bring our staff with us on the journey,” said Gerry Leonard, Director of Research Development at the trust.

Working with the NIHR and the Health Research Authority (HRA), the trust has provided a framework for its staff to follow on reopening a study. This framework incorporates a checklist for researchers to follow. Once the checklist is completed, the trust’s research governance team aims to action any requests within five days, though this can often be done sooner.

Dr Mays Jawad, R&D Governance Operations Manager, said there were mixed feelings about reopening studies, the vast majority of which were paused in the early stages of the pandemic.

She said: “It was never the case that all our non-COVID studies were suspended. We did have some cancer studies remain open because some patients still needed their treatment as part of a trial.

“But I think it’s fair to say that there was a mixture of relief and some apprehension when we were reopening studies, because there’s so much to think about in a clinical trial. For example, is it safe for patients, do we have the staff to run it, or access to the facilities in clinical support services, such as CT scans, or is the clinical service even open to deliver the study?

“That’s why, using the framework, informed by discussions we had with both the NIHR, whose own guidance was really good, and the HRA, who were really sensible in their own approach to reopening studies, such as giving us the ability to make most study amendments without prior notification, helped us to put the decision to open studies in the hands of our staff, which is what we wanted.

“We wanted to empower them to make that decision, to involve them in the dialogue. So far, it’s worked out really well.”

To date, the research governance team has processed and approved 101 studies, with 63 still being processed and pending approval. In all, 376 studies had been formally suspended due to COVID-19.

“We knew that the clinical leads had all the information at their fingertips, so we left the decision to them with help from us when they needed it” said Dr Jawad.

Continuing research also meant that the trust could provide job security for staff. Gerry Leonard explained: “The financial consequences of studies not being open to recruitment, particularly in the case of commercial studies, can mean that it’s people’s jobs we are talking about because the funding doesn’t come through if the study isn’t recruiting. So it was really important to us to get studies open again.”

Sometimes, drastic situations can mean much is learned. For the Barts Health research team, restarting studies after COVID-19 has been no exception to this rule.