Nicky Perry MICR
Keywords
Comprehensive Local Research Network (CLRN), Feasibility analysis, NIHR portfolio adoption, Research nurse competencies, Study costing template
The ICR Research Nurse Special Interest Group (SIG) held their
second forum on June 18th at the ICR office. Sixty research nurses
attended. The agenda for the day was set following the training needs
analysis conducted via questionnaire, which was sent out last year. The
result of this survey highlighted that nurses wanted to know more about
study management, especially how to cost a clinical study.
Overview of CLRNs
The day started with Caroline Gunnell, Chair of the Research Nurse SIG and Co-Director, Essex & Hertfordshire Comprehensive Local Research Network (CLRN). Caroline provided an overview of the Comprehensive Networks, and where the role of the research nurse fits in.
The Comprehensive Clinical Research Network in the UK was set up to provide the NHS infrastructure for supporting clinical research via its 25 CLRNs, with the aim of streamlining the research management function and to reduce bureaucracy. From April 2009, it became the main route for NHS service support for clinical research covering all areas of healthcare and all disciplines. The role of the CLRNs is to deliver research management and governance services efficiently and safely, and to support local speciality groups. The aim of this is to recruit local populations to high quality research opportunities delivered by well-trained and competent staff in all areas of health care. Various new initiatives have been implemented including the coordinated system for gaining NHS permission (CSP), a regulatory and governance advice service, Research Passports, which allow staff to work across NHS sites and a new Integrated Research System (IRAS) to enable submission to ethics, R&D and MHRA to happen in parallel.
Caroline highlighted some of the issues faced by nurses working in clinical research in the past, such as working alone on studies, often with job uncertainty and/or on short-term contracts, with little career structure, professional development or funding to attend training courses.
The aim of the CLRNs is to deliver a flexible research workforce, with nurses not working in isolation but with clear and available support and professional development, including leadership skills. Other developments include links with the Royal College of Nursing (RCN) and meetings with the Chief Nursing Officer for England to raise the profile of clinical research nursing. There are now clinical research nurse competencies and, following on from the Modernising Nursing Careers report, seven Higher Education Institutions (HEIs) are now offering MRes courses. Caroline finished by stating “research nurses are the backbone of the success of the new NHS R&D strategy, the CLRN is there to support this army as long as it is seen to be recruiting the participants to the portfolio studies”.
Research nurse competencies
The second presentation of the day was by Dr Les Gelling, who is a Senior Fellow at Anglia Ruskin University and a member of the Research Nurse SIG. Les was part of the working group who were instrumental in developing the research nurse competencies, which were developed because of the growing number of research nurses working in professional isolation. Often, research nurses are not provided with any formal training; the role is not based on any previously published competencies and they often work outside normal ‘boundaries’ (eg, informed consent). The document went for consultation in June 2008 and published in December 2008.
Les provided the group with an overview of the layout and content of the competency document. For the purposes of the document, a competence is defined as “the ability to demonstrate the application of knowledge, understanding, practical and thinking skills to achieve effective performance in a profession or occupational role. This involved problem solving and being sufficiently flexible to meet changing demands”. The purpose of the competencies is to enable an individual to:
- Understand more clearly what is expected of them
- Identify personal development needs
- To provide evidence of achievements to support development and progression
In preparing the competencies, the working group was keen to provide a framework that was sufficiently flexible to be of use to the many nurses involved in clinical research. It is important to remember that these competencies may need to be adapted for local use. In particular, it might be possible to tailor the ‘performance’ criteria, which describes how the required competence can be demonstrated and the ‘contextual’ factors, which include specific reference to information pertinent to the area of practice within which the competency will be used to meet local needs.
The competencies can be accessed via the ICR RN SIG webpage (www.icr-global.org/community/special-interest-groups/research-nurse-special-interest-group).
Study feasibility
The next presentation was on undertaking a feasibility assessment for a clinical trial. Nicky Perry, Research Manager for HIV/GUM in Brighton and a member of the Research Nurse SIG gave an overview on feasibility assessments: what their aims are and why they are important. The talk then looked at what issues potential sponsors want to focus on, such as:
- What previous clinical trial experience the site may have
- Examples of previous recruitment targets and if they were met
- Are there other competing studies and what is the size of the specific cohort so will the site be able to recruit enough subjects in a timely manner
- What recruitment strategies might be used
- Whether the recruitment timelines are reasonable and can be met
- Whether the site has the facilities, staffing and resources available to conduct the study.
The talk then highlighted some of the issues that sites should consider before taking on new studies, including
- Ensuring suitable patient population
- Recruitment strategies
- Staffing and facility requirements
- Budgets
Finally, some top tips were given on making sure you have enough time to conduct a thorough feasibility assessment. These boiled down to consulting with other colleagues and being realistic!
Costing a clinical trial
The following two presentations focused on how to budget for a clinical trial. Anne Davies, a Clinical Research Consultant, provided an overview of the CRN template for costing a clinical trial. The template can be downloaded from www.ukcrn.org.uk/index/industry/costing.html. The Industry Costing Template has been developed on behalf of the National Institute of Health Research (NIHR) and addresses a specific recommendation made in the Cooksey Report, which highlighted the need for a transparent and consistent national costing system.
The Industry Costing Template has been implemented to speed up the initiation of industry contract trials by reducing the time required for site-by-site negotiations. It is based on the principles articulated in the NHS Finance Manual and is intended to provide transparency, greater consistency and predictability on costing for companies.
Delegates were then given a protocol and asked to put together a draft budget and then the costing template was used to demonstrate how to put together a budget for a potential new sponsor.
Study adoption process
The final two talks of the day focused on the ‘adoption’ process of studies onto the UK CRN portfolio. Vee Mapunde who is Industry Manager at West Yorkshire CLRN and Sue Mackay, Research Team Manager at CDSS Ltd and a RN SIG member spoke. Vee described the process for getting non-commercial studies adopted and which type of studies are eligible for adoption, which is based on who the funder is, and can be split into high, medium and low priority areas. Sue then gave the industry perspective. The benefits of studies being adopted include:
- Additional support from the UKCLRN
- Access to resources and staff for smaller units wanting to get involved in clinical research
- Additional funding for sites
The aim, as described earlier in the day, is to ensure studies are scientifically robust and recruitment is efficient and patients have access to studies.
Positive feedback
There was plenty of discussion and sharing of experiences during the day and it was great to see so many research nurses come together for networking and learning!
Feedback from the day was overall very positive and included:
- “Enjoyed workshop, validated a lot of the thoughts and feeling about working as a research nurse. Enjoyed being able to network and learn from other nurses.”
- “The forum was very informative and the knowledge gained will help in my new role as a CRN.”
- “Good range of subjects and viewpoints from expert presenters.”
We also received some useful feedback for future forums – so watch this space!
Nicky Perry MICR is Research Manager HIV/GUM at the Elton John Centre, Brighton and Sussex University Hospitals NHS Trust and Chair of the ICR Research Nurse Special Interest Group.
