Natalie Goulden, Programme Manager at Greater Manchester Comprehensive Local Research Network (GM CLRN), explains how we the NIHR Clinical Research Network can help commercial partners in feasibility.
There should be no room for guess work in the set-up of commercial research studies. They usually need to be set-up quickly, have rigid recruitment targets and short recruitment windows.
The GM CLRN team spends a great deal of time on feasibility, and not a meeting goes by without it being mentioned. But why is it so important?
NIHR Clinical Research Network (CRN) feasibility ensures that studies are only set up at sites that have the right facilities and can recruit the patient numbers required. It takes account of other studies that are taking place, the track record of the investigator, staff available to support the study, and any special equipment or facilities that are required.
However, the way pharmaceutical companies approach finding sites for studies hasn’t been particularly evidence-based in the past. Sites have been selected because the investigator is well known, or the company have worked with them before – regardless of past performance or ability to deliver the proposed study. Sometimes companies end up approaching every possible site in the country.
Network feasibility takes the guess work out of study set-up for sponsors. Rather than approaching sites at random, or only going back to sites they have worked with before, sponsors are able to rely on CRN staff, who have specialist local knowledge and relationships with research teams, to ensure that the right sites are put forward for studies.
When a company approaches the Networks about conducting a commercial study, rapid national feasibility is carried out to ensure that the study is compatible with current clinical care in the UK and can be carried out within the NHS. Once confirmation has been received that the study can be delivered in the UK, the process of identifying local sites begins.
The Industry Team at GM CLRN coordinate the feasibility process for Greater Manchester, working closely with the leads of our Local Specialty Groups to ensure studies are matched with sites and investigators who have the interest, capability and capacity to carry them out.
Expressions of Interest (EOIs) are completed by Investigators (in collaboration with the Industry Team) and provide information on projected recruitment numbers, as well as any additional resources that may be required. The aim in Greater Manchester is for these forms to be circulated, completed and returned to the sponsor in five working days. The sponsor will then decide which sites they are interested in and begin site selection visits, which can go into a much greater level and detail. Whenever possible, a member of the Industry Team will attend these visits, to provide Network input and assess any resource issues.
Since April 2011, we have used this system on the 62 studies that we have performed Network Feasibility for. As these studies open to recruitment we will compare their performance with the original feasibility that was carried out. This is so we can see how our feasibility can be improved in the future and ensure commercial studies are being placed with sites and investigators that can deliver to time and to target.
Natalie Goulden is the Programme Manager for Greater Manchester CLRN, where she leads the industry and primary care team. Her role focuses on developing a strong infrastructure to support the delivery of commercial research, and on building long-term and effective partnerships with industry.
