Restarting research: how a digital approach is enabling studies to reopen in Leicester
As the NIHR CRN Restart project sees the resumption of non-COVID-19 research studies across the country, Carolyn Maloney, Head of Research Operations at University Hospitals of Leicester NHS Trust (UHL), explains more about her organisation’s approach to unpausing research…
“We decided early on that we wanted to develop a process including the people who would be directly involved in each study,” Carolyn explains, “and that working collectively was the most important element to enabling us to deliver research that is COVID-19 secure.”
Using the NIHR Restart Framework, UHL developed an approach that provides people with opportunities to input into the viability of each study, as well as a vehicle to discuss any changes that need to be made to how a study is delivered.
“We understood that things would constantly change and develop,” Carolyn says, “so our priority was to develop a process that would be a strong starting point, whilst providing multiple opportunities for people to raise concerns or put forward ideas that we could integrate to improve the experience for participants.” She believes that this method has helped ensure that all staff involved in research are comfortable with the approaches being taken, which in turn helps to provide reassurance to participants.
The process begins with a conversation to explore whether a study remains viable, providing all relevant parties including individual specialities with a forum to discuss how a study could be restarted. This discussion includes looking at alternative methods of delivery to reduce patient contact such as the use of phone or digital consultations, ensuring there is adequate funding for PPE, and developing a plan to make sure that each study is COVID-19 secure.
Once viability is confirmed at site, the process uses a series of digital tools to enable the capture and reporting of information to inform the process. “Individual specialties use a Google Form to submit information, which is then transferred to an EDGE attribute,” Carolyn says. “We then use Power BI to identify studies with this attribute that could potentially re-open, and discuss these studies at our weekly team meeting.” Once each study has been discussed, a report is produced and an email distributed declaring that a study can re-open if the sponsor is in agreement. “We also provide time within the process for the CRN and all relevant support departments to review and comment on each study,” Carolyn adds.
Carolyn believes that integrating a digital approach has made the process more effective. “We’ve managed to automate elements of the process, and because we run reports and require information at set times it has helped us all to focus on meeting deadlines,” she says. The approach to Restart has enabled over 150 studies (25% of all studies that were paused) to be opened over the past six weeks.
The key element to make restarting research a success, Carolyn believes, is flexibility. “We said that we wanted to make progress but understood that not everything would be perfect right away,” she says. “People understand that we are living in challenging times and that things might change, but we know that by working together, sharing our ideas and concerns and focusing on participant safety we can deliver research that is safe and beneficial for all involved.”
Carolyn’s top tips for other trusts:
- Take the time to explore what can be done virtually - patient safety is paramount
- Make processes collective and collaborative so that everyone involved is invested
- Be prepared to make adjustments and learn from other people’s experiences
- Processes must be responsive with space to evolve as circumstances change