Networks offer new opportunities for diabetes research

1.1. Public opinion 

Despite being relatively silent when compared to the might of, say, the Alzheimer's disease, breast cancer or the HIV/AIDS lobbies, the alarming statistics of diabetes are beginning to filter into the collective psyche. A recent survey commissioned by ICM Research in the UK indicated that diabetes is now recognised as being a major problem by the general public. Eight percent of those surveyed stated that the condition was their number one priority for NHS spending [3]. Whilst this fell some way short of the 72% highlighting cancer, the 33% stressing heart disease and the 11% recommending Alzheimer's disease, diabetes came a respectable fourth in the survey. Interestingly, in the same poll, only 17% of those surveyed were either very confident or confident that enough money was being invested in new treatments for diabetes.

1.2. Diabetes pipeline 

This powerful and tantalising combination of an increasing awareness and an already sizeable marketplace has encouraged academia and the pharmaceutical industry around the world to focus their efforts on diabetes. As a therapeutic category, antidiabetic treatments are in third place in the global pipeline with over 500 molecules under investigation in 2008 [4]. This has increased from just 394 in 2007 representing an almost 25% rise in research and development (R&D) over this 12 month period. In addition, two related therapy areas including anti-lipaemic and anti-atherosclerotic therapies, also reported significant rises in R&D activity highlighting the importance of metabolic diseases within the overarching diabetes arena.

1.3. Costs 

The economic burden of diabetes is particularly onerous. The International Diabetes Federation estimates that between 7% and 13% of the total world healthcare budget will be spent on diabetes care by 2025 [5]. Some high prevalence countries will, however, spend more than twice that figure.

In England, 2.35 million people have diabetes. This increase is estimated to be 60% due to rising obesity levels and 40% due to the aging population. The cost implications for the NHS are staggering. Diabetes accounts for 5% of all NHS expenditure and 9% of hospital costs [6]. This equates to around £9.6m per day. Most of the workload for the care and management of diabetes falls to general practice and this will only increase with the rising incidence of the condition.

2.1. Diabetes Research Network infrastructure 

The DRN is a network of primary and secondary care centres throughout England supported by the Department of Health for the purpose of conducting high quality clinical research in both the commercial and academic sectors.

The co-ordinating centre for this network is an innovative consortium forged between Imperial College London and the Oxford Centre for Diabetes, Endocrinology and Metabolism. This co-ordinating centre manages eight local research networks (LRNs) which are designed to provide geographical coverage around the country.

Since its inception, the DRN has striven to establish important working relationships with parallel Diabetes Research Networks in Scotland, Wales and Northern Ireland. Working together, the DRN is continuing to deliver a shared strategy to improve the levels of care of people with diabetes across the UK via research and to facilitate their involvement in a portfolio of high quality research studies [8].

Each LRN within England is centrally resourced to provide the infrastructure to support robust randomised controlled clinical trials and other high quality studies in diabetes performed both at primary and secondary care levels. This allows both accurate and rapid assessment of the feasibility and timely recruitment into studies.

Already each of the LRNs has established important links with primary care. Many general practitioners are now involved with the network and about one sixth of the DRN's industry portfolio is co-adopted with the Primary Care Research Network.

Between £300 and £495k has been provided to each network annually to employ dedicated research nurses and similar staff who support clinical teams in hospitals to facilitate involvement in diabetes clinical studies.

2.2. The Diabetes Research Network in primary care 

Increasingly, patients with diabetes – particularly Type 2 diabetes – are managed in primary care as care pathways continue to move away from hospital settings into the community. For the DRN to reach many of the patients required for clinical trials, it has been vital to establish close working links with primary care. Access to patients in these settings is also essential for prevention or risk factor modification studies; for example, studies aimed at reducing the risk of progression to diabetes for high risk individuals with risk factors such as obesity or impaired glucose tolerance.

A key step in establishing a successful relationship with primary care is by building relationships with the DRN's sister network, the Primary Care Research Network as well as with the newer Comprehensive Clinical Research Networks. The Primary Care Research Network covers all of England and overlaps in coverage with the local diabetes networks. The Primary Care Research Network is working to establish the research infrastructure for studies that recruit patients in primary care, such as research and development practices. This has been coupled with an out-reach strategy, such as local meetings for primary care professionals, site visits, internet-based communication and newsletters.

The new Comprehensive Clinical Research Networks are responsible for NHS support costs and also have a key role to play in supporting primary care research. They would, for example, be responsible for meeting the cost to general practices for identifying and recruiting patients for diabetes research projects. In many areas, the various networks are forming joint working groups to ensure they work together effectively. In NW London, a primary care forum comprising the Primary Care Research Network, the NW London Comprehensive Clinical Research Network, and Topic Specific Research Networks, such as the DRN, has been established.

Examples of innovation at a local level have been encouraged and many of the LRNs have pioneered new out-reach methods to reach primary care colleagues who may be interested in participating in research but who have been, until now, unable to participate. A new GP liaison officer has been appointed who has been working with other staff to raise the profile of diabetes research within practices and to develop a ‘matrix’ of all GPs expressing interest in the network and their preferred participation level of giving referrals only, being a co-investigator or participating as a principal investigator.

2.3. What can the Diabetes Research Network offer to primary care? 

The Diabetes Research Network offers general practices and primary care professionals the opportunity for them and their patients to participate in high quality research studies. For practices and professionals, this can add to their job satisfaction. Practices can also benefit practically; for example much of the data they need to meet the requirements of the Quality and Outcomes Framework in the new general practitioner contract or for the new Vascular Risk Assessment programme could be obtained by research staff collecting similar data for projects. This means that practices can meet contractual requirements with less effort on their part. There are also some financial benefits – albeit modest – for taking part in research projects.

Patients can benefit from taking part in research studies [9]. The monitoring that they receive in research studies is usually more intensive than that in routine clinical practice, and they may also benefit from access to innovative diagnostic tests and the latest treatments for diabetes. Interventions may be pharmacological but may also encompass behavioural change or increased nurse support. And since patients in studies will be in regular contact with research nurses and clinicians, they are likely to learn more about their condition and its management.

3.1. Clinical Studies Group 

In order to ensure that the portfolio maintains a full spectrum of research, the network has established a wide-ranging Clinical Studies Advisory Group research group which generates research ideas addressing important questions pertinent to the NHS (in both primary and secondary care) and which can attract funding.

In April 2008, the Clinical Studies Advisory Group published its research priorities document which outlines the areas that the group feel are important to highlight and to encourage innovative and original proposals in diabetes research. The identified areas include many proposals highly relevant to general practice diabetes care and management including: screening, obesity and service delivery.

Building on the successful model created by the Cancer Research Network, the Diabetes Research Network has also launched a series of invitations to assemble writing groups. Their role is to provide a creative drive by working with the Clinical Studies Advisory Group to address gaps in the current portfolio.

Each of the groups awarded has been expected to turn their research ideas into suitable funded studies. Formed with between 5 and 20 geographically disparate researchers, some at a senior level, the groups have had input from multiple academic disciplines and institutions, and they have encouraged the engagement of service users and carers. Those awarded thus far include a range of topics—pregnancy, retinopathy, telemedicine and education.