CSO Health Research Strategy

CHAPTER 2 - PARTNERSHIP WITH SCOTTISH PATIENTS AND THE PUBLIC

2.1 The Scottish public are at the heart of clinical research, both as healthy volunteers participating in early stage studies and as patients benefiting from improved diagnosis or treatments. Without patients enrolling to take part in clinical research, very little of the research in the NHS would be possible. The insights and views of patients, carers and relatives are also immensely useful in ensuring the successful delivery of well-designed, scientifically valid research that has relevance to the people of Scotland.

CSO Public Involvement Group

2.2 Since 2001 CSO has involved the Public in both Grant Funding and Policy areas through the CSO Public Involvement Group. We acknowledge that the Public Involvement Group plays a key role in representing the public's interest in CSO's work, providing a vital lay view of policy and research proposals.

2.3 Over the last 6 months we have carried out a fundamental review of public involvement activities both within CSO and the NRS research Network structures. While there was much excellent work being undertaken by the CSO Group under the leadership of its Chair Joan Munro, we recognize jointly that there are opportunities to enhance the work of that group in providing advice and support to CSO. Key areas to be taken forward include:

• The group will be renamed the CSO Public Engagement Group (PEG).
• There will be broader representation in the work of CSO, including lay participation at CSO policy and strategic committees
• There will also be greater lay involvement in the planning and review process of CSO investments such as funded units, Bio-repositories and the focus of CSO grants
• The role of lay representation in raising public awareness in the understanding of clinical research will be developed further

2.4 Our NRS Networks also heavily involve the public at steering group level as well as directly with research. However there is more that can be done in developing best practice in these areas and we propose bringing these groups together to build a greater sense of common enterprise. CSO will continue to encourage the component parts of NRS to directly engage with patients and patient groups, and further develop ways in which members of the public can be empowered to become actively involved in clinical research.

2.5 CSO will require the newly restructured NRS Research Networks to show evidence of involvement with the public in their work, and to embed patient and public involvement in their management processes.

Scottish Health Research Register

2.6 CSO is also funding an initiative for members of the public who wish to express an interest in being contacted about participating in research. Following registration on the Scottish Health Research Register (SHARE), details of participants will be maintained on a database of those who are willing to be approached about taking part in research studies. Through electronic linkage of health information, SHARE will be able to identify potential recruits for studies far more efficiently than at present. Initially funded through a CSO small grant, SHARE has now been brought within the NRS Infrastructure budget to ensure sustainability and facilitate larger scale recruitment . There are already over 25,000 people on the SHARE register, but the long term goal is to create a far larger register for use in relevant studies.

2.7 Although SHARE provides an opportunity for many to indicate a general willingness to be approached to take part in research, routes for facilitating involvement for patients who want to take part in specific studies are relatively underdeveloped. Patients may wish to contact investigators directly if they become aware that a study is enrolling patients with a specific diagnosis. However given the very specific scientific design of most trials, entry to studies cannot be guaranteed, and there is currently no process to manage such requests appropriately. For this reason CSO is also committed to explore the creation of a Scottish Clinical Trial Register.

2.8 Although medical researchers often find it difficult to identify suitable patients for clinical trials, it is often equally hard for patients interested in taking part in trials to find clear, accessible information about studies. Current lists of active studies do not generally provide lay summaries of what projects involve, and current mechanisms to signal an interest are not always direct or well-maintained.

2.9 CSO will develop a secure website allowing NHS patients across Scotland to identify clinical trials which are actively seeking participants. Patients will be able to review a list of available studies, and express their interest online. Patients will be able to express an interest in studies open anywhere in Scotland which may require them to travel. Any studies that are only recruiting locally will be identified as such on the Register. When applying through the website, a patient will give consent that they can be assessed for entry into trials by comparing their medical records against the eligibility criteria for the relevant study. A response will be provided to the patient within a short period of time. If the patient meets the study general eligibility criteria, their details will be passed to the study investigator for a more detailed assessment and consideration. The Register will work closely with SHARE, and patients who have not been found eligible for their preferred study will be given the opportunity to register for SHARE, which will provide an additional mechanism for them to identify studies of interest to t hem. A pilot Trial Register will be developed initially.

Question 8: Would a trial register be of benefit to patients seeking trials? Would it be an effective way to partner patients with researchers? Is there a danger that expectations of taking part could be unfairly raised?

NRS Recruitment Service

2.10 NHS clinical data is routinely used to inform planning decisions. Care of some chronic conditions, such as diabetes, has been transformed by the availability of electronic systems to track the progress of the disease. Clinical registries have also been invaluable in gathering data to inform the development of clinical practice, services and research.

2.11 Aggregate data derived from NHS health records allows planning and feasibility assessments of the potential success of research projects to be made. However, individual patient data is not currently used to inform patients about research projects that would be of personal relevance to them.

2.12 We recognise there is a sensitivity over who has access to patient clinical data. Projects such as SHARE therefore require potential participants to register their general agreement for their electronic records to be checked. This, however, limits the identification of patients who may have access to new treatments available through clinical trials to those who have previously registered an interest. As a consequence, patients undergoing treatment in the NHS are not routinely informed of research taking place that could be relevant to them.

2.13 We believe offering patients participation in clinical studies should be a key aim of the NHS as an integrated part of patient care. Assisting GPs and hospital consultants in identifying patients who might be invited to participate in a research study relevant to their condition is therefore a service we believe worthy of consideration. We believe NHS staff using NHS patient records solely to advise GPs and hospital consultants of trials that may be of interest to their patients strikes an acceptable balance of security and service to patients.

Question 9: Would using electronic NHS patient records to alert GPs to research studies for which their patients may be eligible be a service the NHS should offer? If so, would a process where NHS records are only accessed by identified NHS staff working in secure facilities, and only passing potential participant names to their GPs or hospital consultants for consideration, be a suitable way to proceed?