Clinical research
The UK has a long established and successful record of clinical research, especially in the clinical trials of medicines.
In recent years there has been a cultural shift to enlarge the boundaries of clinical research on medicines and medical devices from the study of these entities under ideal clinical conditions to the assessment of their cost-effectiveness and their impact on quality of life (QoL).
At the same time, the clinical and social value of healthcare delivery in many areas of patient care has come under closer scrutiny with government, healthcare providers, and patients demanding evidence that a difference to standards of care and QoL is being made.
These changes in emphasis have required establishment of new specialties, scientific evaluation systems and clinical networks. Two other factors have had a major impact on clinical research in the UK.
The first is the view that the pharmaceutical industry takes of the ability of UK investigators to conduct and deliver on clinical trials of new medicinal products. This view is not altogether favourable: UK clinical investigators are judged to be well-informed and contributive, but to be unreliable, expensive and unlikely to deliver the required number of participants on time and to budget.
The responses to that criticism have been a concordat between government, industry, academia and the NHS and the establishment of the UK Clinical Research Collaboration (UKCRC).
This response, plus a wide-reaching new national strategy for clinical research set out in the Department of Health’s 'Best Research for Best Health: A New National Health Research Strategy', has resulted in new local and national research networks, new funding procedures and streamlining and standardising of research governance procedures.
The second driver affecting clinical trials of medicines and devices, has been the shift towards a European regulation system, incorporated into UK law as the Clinical Trials Directive.
This has resulted in a tightening of regulations for all aspects of trials, particularly the application procedures and the standards, and degree of, monitoring embodied in Good Clinical Practice (GCP) for research.
Clinical research thus stands at a crossroads. On the one hand, keeping up with the constant change and with the phasing out of familiar sources of funding is often difficult and frustrating for researchers.
On the other hand, the UKCRC and Department of Health initiatives, combined with the positive attitude of industry to collaboration, offer challenging opportunities for the future.
Further, with the unique geographical positioning of this part of the UK, particularly with respect to innovative pharmaceutical and biotechnology companies, local researchers are well placed to take advantage of these opportunities.
The University of Hertfordshire has therefore set up the Clinical Trials Support Network (CTSN) to provide a focus for advice, support, participation in, and management of, clinical research, especially clinical trials, across the counties of Hertfordshire, Bedfordshire and Essex.
The local primary care networks are part of the Primary Care Research Network – East of England. The Centre for Research in Primary and Community Care is taking the lead for this network on patient and public involvement in research.
Individual clinicians have links with some of the topic specific networks. The CTSN also works in liaison with the NIHR Research Design Service for the East of England (RDS-eoe).