Moving diabetes research trials to GP surgeries: Benefits for all concerned

Within the last year, the Scottish Diabetes Research Network has been running an initiative where a GP practice hosts a Diabetes Specialist Research Nurse on a weekly basis and we conduct clinical drug trials entirely within the practice.

There are advantages for all parties involved in research (people with diabetes, the NHS and the academic researchers/pharmaceutical industry) in conducting research in primary care and this month’s column will briefly discuss these advantages.

Benefits to the person with diabetes
The advantages to the person with diabetes are mainly logistical, but there is also a huge psychological element. It is often much easier for people to get to their GP practice rather than a large hospital, especially as hospitals usually have limited and costly parking spaces. Furthermore, taking part in research at your GP practice can be much less frightening than attending a clinical research facility at a hospital.

Research clinics that run on a weekly basis also demonstrate that research can now be viewed as part of normal clinical care. People waiting to attend research appointments will often mix with people attending clinical appointments and chat about the studies they are participating in, which raises awareness of diabetes research and clinical research in general. Obviously, the drug trials that we conduct in primary care are mainly phase III or IV and are very straight forward, so it is a nice, easy introduction to trials for research-naïve patients.

The other significant clear advantage for research participants is the extra care and attention they receive throughout the trial. The research nurses are all Diabetes Specialist Research Nurses and provide holistic care as well as collecting research data. Many of the people involved in the studies are diabetes drug naïve and fairly newly-diagnosed, so the diet and lifestyle counselling that they receive at each study visit helps with reinforcing the information that they will received at diagnosis. One of the participants recently said:

“I’m really glad I’m taking part in the study as I feel it’s helping me to get to grips with my diabetes.”

As there is usually less time pressure on the study visits for the research nurse then he/she can spend more time with the individual and discuss diet and exercise in a very personalised fashion. Often the participants are given a blood glucose meter and supplies as part of the study and this can help greatly in helping them understand the effects of various foodstuffs and exercise on their glucose levels. As these individuals are diet-controlled or on a single antidiabetes drug, they would not be eligible for a blood glucose meter according to NHS Scotland guidelines. Participants also receive lots of extra tests compared to standard clinical care, so there is always the possibility of incidental findings. For example, an electrocardiogram may show a myocardial infarction or cardiac abnormality that has no clinical signs.

In general, people participating in clinical trials tend to improve their diabetes control, often irrespective of which randomised treatment they are receiving, and have fewer complications. It is important to note, however, that there is also the possible bias that it is the more motivated individuals who volunteer to participate in clinical research.

Benefits to the NHS
The advantage of this initiative for the NHS is that the research participants are getting increased care from the research nurses and this should empower the participants to manage their diabetes better and will have lasting effects on their wellbeing. The research nurses are working towards the NHS objectives of improving the health of the population. The income generated by commercially sponsored trials helps to increase the number of Diabetes Specialist Research Nurses working in primary care and, therefore, the initiative is financially sound and self-funding, a factor that is particularly important to the NHS during this age of austerity.

Benefits to the academic researchers
The advantage to academic researchers working in the diabetes field is that the individuals that the initiative is targeting are often newly-diagnosed with diabetes and they tend not to have so many comorbidities or polypharmacy. Scientifically, this makes these people easier to research as they have fewer confounding factors. Complex studies, such as those requiring magnetic resonance imaging or dual energy X-ray absorptiometry scans, will involve a visit to hospital but genetic studies can be easily and efficiently conducted within the GP practice.

Benefits to the pharmaceutical industry
This initiative also benefits the pharmaceutical industry, who will often fund the research in question. The main advantage to the pharmaceutical industry is access to an eligible population for their studies. Many of the drugs currently being developed for use in diabetes are targeted at individuals early in their “diabetes journey”; the drugs are often second- or third-line treatment options after metformin. These individuals rarely attend hospital outpatient departments and are often cared for solely in primary care. Therefore, it is far easier to conduct these trials by taking the research to the people rather than expecting the people to travel into hospitals.

Conclusion
Practice staff rarely have the time to incorporate research into their jobs, so the addition of a dedicated research nurse to the practice team on a weekly basis means that the GP practice can participate in diabetes research with little call on existing practice resources. We have now been running this initiative for almost six months, so my next column will discuss the logistics of running this pilot as well as some preliminary results from it.