Research in the NHS

Ian Maidment, Senior Pharmacist, Kent & Medway Partnership Trust. June 2008

 

Research in the NHS is changing rapidly, with the introduction of new structures and funding streams. This section aims to provide background for pharmacy staff on these changes and potential opportunities.
This page has been produced by Ian Maidment, and we would welcome comments on the section including constructive criticism via email at ian.maidment@nhs.net
 
National Institute Health Research (NIHR)
www.nihr.ac.uk/Default.aspx
The NIHR was established following the review “Best Research for Best Health”. It is a virtual body and provides the support and infrastructure for all types of research including clinical trials involving an investigation medicinal product (IMP).

UK Clinical Research Network (UKCRN)
www.ukcrn.org.uk/index.html
The UK Clinical Research Network was formed to support clinical research and facilitate well-designed clinical trials and other studies across the UK. It contains the disease specific networks, the primary care research network and the Comprehensive Local Research Network (CLRN).

Disease Specific Networks

Within England 6 disease specific networks have been established; the most relevant for the UKPPG are the Mental Health Research Network (MHRN;www.mhrn.info/index.html)and Dementias & Neurodegenerative Diseases Research Network (DENDRON; www.dendron.org.uk). Similar networks have been formed in Northern Ireland, Scotland and Wales (www.ukcrn.org.uk/index/networks/uk_wide.html).

Studies are adopted by the network centre, and fed out to regional Hubs, who recruit patients to studies and have the infrastructure support studies. Each network has about 8 hubs and covers about 50-60% of the UK population, although links are currently being developed with areas not covered by a hub.

The network head offices obtain support from Advisory groups such as the MHRN pharmacy group. Professor David Taylor is pharmacy lead for the whole of the MHRN, sits on the central executive representing pharmacy issues and is linked with the 8 pharmacy hub leads. It is hoped that a formally recognized Pharmacy Research team will be established within the MHRN, which will carry out funded research.

Comprehensive Local Research Networks (CLRN)
www.ukcrn.org.uk/index/networks/comprehensive.html
The CLRN cover all disease areas; there are 25 in the UK, currently only covering England. The average annual budget of a CLRN is £2 million and the overall role of the CLRN is too establish and fund research infrastructure to support UKCRN portfolio studies including those from other networks. Each CLRN contains a full-time manager, research governance staff, clinical research officers, administrative staff and a 0.5 WTE clinical director. Day to day operation is supported by an Executive Group, led a clinical director with representation from primary, secondary and tertiary care, and mental health. There is also a Network Board, which provides over-sight of the CLRN activity and includes representation from all the NHS organisations, and relevant higher education institutions. 
Pharmacy has been identified has one of the major areas with limited capacity to support studies involving a Clinical Trial Investigation Medicinal Product (CTIMP). The CLRN are therefore working closely with Chief Pharmacists to target investment; mental health trusts need to ensure that they are involved in this process.
The CLRN was only formed in 2007 and in the future, to assist recruitment to clinical trials, there is likely to be closer linkage between CLRN and other networks, particularly as the CLRN cover the whole of the country.

Prescribing Observatory in Mental Health
www.rcpsych.ac.uk/researchandtrainingunit/centreforqualityimprovement/prescribingobservatory.aspx
The national Prescribing Observatory for Mental Health (POMH-UK) was formed in 2005 and aims to help specialist mental health services improve prescribing practice. Currently, over 40 mental health Trusts have participated in POMH quality improvement programmes, which involve a clinical audit cycle against evidence-based standards and bespoke change interventions. The programme also includes the provision of benchmarked data to allow prescribing practice to be compared with other Trusts.

Clinical trials
Two major standardised UK systems have recently been developed a model Clinical Trial Agreement (mCTA) and a costing system. First, the standard mCTA has been developed by the Association of British Pharmaceutical Industry (ABPI) and the Department of Health (DoH). These legally binding contracts have been developed to be legally secure and protective in terms of indemnity. They should therefore be used unmodified for any clinical trial since modification may affect legal liability.
Two types of Model Clinical Trial Agreements (mCTA) have been developed -
a. Biparty – between a host Trust and sponsor (usually pharmaceutical company).
b. Triparty – between a host Trust, sponsor (usually pharmaceutical company) and CRO (Clinical Research Organisation)
Both model agreements may be viewed from the following link -www.dh.gov.uk/en/Researchanddevelopment/A-Z/DH_4002073
Second, a UK wide system for calculating the costs including any pharmacy costs associated with clinical trials has recently been produced –
www.ukcrn.org.uk/index/industry/costing 

Grant Opportunities
As part of the re-structuring various NIHR funding opportunities have been developed.
Efficacy & Mechanism Evaluation (EME) programme www.nihr.ac.uk/programmes_research_programmes_eme.aspx
This programme aims to support 'science driven' studies usually RCTs.

NIHR Fellowships
www.nccrcd.nhs.uk/nihrfellow  
This scheme aims to support clinicians with a track record in research and “buy-out” the clinicians’ salary.

 

Research & Development Support Units (RDSUs)
www.national-rdsu.org.uk/
Capacity, support and mentoring issues all require consideration in developing grant applications. NIHR grant streams are very competitive (approximately 10-20% success rate) and to develop a single application is relatively time-consuming e.g. 3 hours a week for up to 3-6 months. To assist clinicians with the process a network of RDSUs, linked with academia has been developed.

Pharmacy White Paper
The recent pharmacy white paper has a large section on research. It makes a number of recommendations. One priority is that the evidence-base in relation to clinical pharmacy must be improved, and further to this the Chief Pharmaceutical Officer (CPhO) will link with the NIHR to identify research priorities. However, one major problem identified is the current lack of research capacity.

Research passport
www.nihr.ac.uk/systems_research_passports.aspx
The Research Passport system aims to simplify administrative procedures when issuing honorary research contracts to researchers with no contractual arrangements with the NHS, and who carry out research in the NHS that affects patient care. It also aims to reduce excessive paperwork including unnecessary criminal record bureau (CRB) checks.

 

 

Last updated 8.7.08

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