Policy responses and statements

Name of organisation:

Scottish Executive - Chief Scientist Office

Name of policy document:

New Health Research Strategy

Deadline for response:

29 April 2009

Background: The Research Strategy for Health and Healthcare was published in 2003 and is now being revised. The Chief Scientist Office consulted in July 2007 about changes of emphasis and priorities, and this consultation document has now been made available to reflect the feedback given in that process. The document invites opinion on how best to address these ambitions.

COMMENTS ON
SCOTTISH EXECUTIVE - CHIEF SCIENTIST OFFICE
NEW HEALTH RESEARCH STRATEGY

The Royal College of Physicians of Edinburgh welcomes the opportunity to comment on this strategy and has taken account of the views of a range of Fellows in Scotland who are experienced researchers. This response is structured around the questions in the consultation document.

1.1 Do you support this general approach towards emphasising translation of research into improved care? Are there other issues to which a higher priority should be assigned?

Yes. The CSO emphasis on early translation research through its ability to offer support for pilot work in advance of larger scale research investment from other funders is important. However, in the move towards prioritising translation research, Scotland must not lose its interest in important health (including public health) priorities eg CHD and stroke.

It is vitally important that the NHS promotes an evidence-based approach to the management of patients. Such an approach requires data on the effectiveness and safety of interventions to be generated quickly and effectively. The NHS is an ideal vehicle within which these data could be gathered, were the various elements of routine data collection more “joined up”. This vehicle would significantly enhance the evidence-base at an early stage where the cost-effectiveness and safety of new medicines and other interventions are particularly important. Whilst the College supports the approach to translational medicine, the infrastructure required to do this efficiently needs attention. Government statistical agencies set up to produce health statistics are ideally placed to take over a more central role in the provision of research vehicles. For example, the Medicines Healthcare Regulatory Authority runs a database called the General Practice Research Database in England. This database links together data from GP practices and from hospital episodes statistics into one single anonymised database suitable for research on the safety and efficacy of interventions. This model and record linkage models developed elsewhere could be implemented across the entire NHS for the good of all participants.

1.2 Do you support the focus on translational research and sustaining success?

Yes. Translating innovations into evidence-based healthcare is a key issue. Whilst bench to clinic translation is important, post-licensing use translation of new interventions is another key issue. Effectiveness and cost-effectiveness of interventions could and should be judged early and could become part of the ‘culture of research’ within the NHS accessing large sample sizes through patient care in Scotland. Such a systematic approach would also be extended to patient safety and would largely avoid difficulties with trying to judge the safety of interventions based on very sparse data. Thus, NICE and the Scottish Medicines Consortium would be able to make decisions on a much more evidence-based framework with good external validity.

2.1 Do you support these moves towards developing Scotland-wide collaborative structures?

The College is supportive of these proposals, particularly the division of significant research roles between the larger Health Boards, but has several comments:

• Significant stream-lining is required eg currently a Scotland-wide study is virtually impossible for a single principal investigator. Whilst ethically this might be possible, NHS R&D departments currently require the involvement of a ‘local’ principal investigator in all studies including those run beyond their area. Also, Health Board R&D approval systems would benefit from additional recruitment of experienced researchers to run these systems.
• The NHS research passport, whilst a good idea, is incredibly bureaucratic and would benefit from review; the current form for a research passport is 140 pages long!
• Whilst a national co-ordinating centre seems like a good idea, the College would like to see greater detail of how this will work in practice. Also, Scotland is too small for some types of study and our co-ordination should extend across the UK. It is important that researchers in Scotland are supported to understand the UK-wide structures and how systems in Scotland match or differ from those in England. Nomenclature should be the same where possible.

2.2 Is providing the aforementioned stability in the Support for Science allocations for 3 financial years a sensible approach?

The College agrees that the basis of NHS funding of science should be reviewed. Large amounts of money are allocated with little in the way of hard outcomes. Freeing up the infrastructure funding for reinvestment to support research has some merit, although the alternate use of this funding needs careful thought to secure maximum investment in research staff and minimal expenditure on support costs.

The College notes that no change will be implemented for 3 years. However, there are concerns that this delay will make the introduction of change more difficult and urges the CSO to consider making changes as soon as the results of the review are available.

The College is concerned about the concept of generic research nurses because, although attractive financially, there are difficulties in securing the necessary skills and training required for specific research projects. The lead time from appointment to competence is often measured in months. Thus, a generic research nurse is rarely able to pick up a study in another research area without significant training. Whilst career stability is really important for research staff, there is limited evidence that working on several studies simultaneously is effective. The best teams have clear leadership, clear objectives and clear priorities, and the ‘generic’ researcher concept muddies these clear objectives. We would be cautious about building more generic structures in terms of the Support for Science decision until there is clear evidence in favour of this model.

2.3 Should pilot work – designed to lead to externally funded studies – currently supported through NHS programmes be funded in future through the Support for Science arrangements?

In general, this seems a sensible approach.

2.4 More generally should CSO aim for a wider rationalisation of the NHS funding streams at the end of the transition period comprising 2 main funding streams – Support for Science and NHS Infrastructure support?

The College supports the transition of these schemes into real and identifiable funds to be used for research. The need for discrete themes is less clear, and it would be helpful for the fund managers to have authority to vire between them and for scoring systems to ensure that basic science and clinical research are assessed equally rigorously. It may also be helpful to consider the likely cost-effectiveness of proposed new interventions and therefore the future costs to NHSScotland when allocating research funding.

2.5 Is the principle of R&D Management being made more accountable for its performance accepted? Is there scope for a wider rationalisation of Health Board R&D Management arrangements? If so, what might such a model look like?

The College supports the proposals to make R&D Management much more accountable and recommends a cost-effectiveness review of the smaller units across Scotland. It is unclear why Scotland needs so many independent NHS R&D departments, although there are some benefits of a local presence supporting local investigators. Accountability is a hallmark of good research, and accountability of research managers must surely follow. However, it is also important to ensure that while/if smaller units continue, they not starved of funds by larger, more central research units.

NHS R&D has been responsible for much of the increased bureaucracy and subsequent delays and frustrations in research programmes. A multi-centre study can take 18 months to achieve R&D approval across Scotland, and a single point of contact for national approval may deliver a more sensible approach. This would undoubtedly have efficiencies of scale, avoid regional variations in decision-making, and would be much-welcomed by researchers.

3.1 Does this distinction remain the most useful basis to share work between 2 committees?

The distinction between medical and therapeutic research and health services research has become blurred with time. The College would encourage the consideration of a single research committee with realistic levels of funding targeted at the clinical end of translational medicine. Whilst the development of biomarkers and genetic therapies are of academic interest, they are often many years away from producing any benefit. Research aimed at assessing the benefits and risks of current treatments, assessing the benefits of improved organisation of care and assessing the benefits and risks of novel treatments currently licensed are where most of the next generation of health gains are to be made. There are other established funding bodies to support ‘blue-sky’ research and basic laboratory work and the CSO should target its efforts towards clinically-orientated, patient-orientated research outputs.

Whilst the College would support a portfolio of small and large projects being funded, we think that, realistically, most of the benefit to the NHS will come from larger research projects. Good Clinical Practice and other regulatory requirements have made the costs of large clinical trials increasingly expensive. These costs could be moderated if Scotland developed centralised facilities for audit and monitoring of studies, pharmacovigilance and for providing eCRFs and data management.

3.2 Imaging will be a particularly important tool – are there specific needs for imaging projects that could be better supported by BTRC?

Whilst it is popular to say that imaging will be very important, there is limited clear evidence and CSO should consider carefully before investing their limited funds further in equipment/facilities to support research. It may be possible to use existing scanners etc more effectively for both patient care and research. Also, by providing research facilities with an emphasis on specific technology, the CSO risks a “command and control” rather than “response mode” approach to research, which may limit the variation in research topics as has happened in England as a result of restrictive calls from the NIHR.

3.3 Is there more that CSO should do to maximise Scottish success?

Clinical research centres across Scotland do not run at full occupancy, and there may be an opportunity to offer spare capacity to commercial partners.

Clinical research is held back by the reluctance of many patients to participate in clinical trials. The consultation document states that one of the objectives is to make research part of the NHS culture, and there may be benefit in a specific initiative to engage the public interest in research.

Finding ways to encourage greater participation by general practitioners in research projects would also be helpful.

3.4 Should CSO do more to support testing of healthcare technologies in the NHS? If so what form should this take?

Validation of healthcare technology should in principle be little different from other healthcare interventions. However, healthcare technologies often involve steep learning curves before they can be used to best effect. Indeed, the learning curve often results in modifications to the technologies and makes them more usable. The testing of healthcare technologies involves significant training and evaluation. One issue that might improve this process is to give the assessment of new technologies a higher priority in the Scottish Health Research Strategy, or to formally join up with the NIHR HTA scheme, as such assessments often require large numbers and significant funds.

4.1 What more can CSO do to develop joint initiatives in public health research?

Scotland has many advantages for public health research that should be exploited; an appropriately sized population, some of the capability, advanced health datasets and (regretfully) larger numbers of “health events”. The CSO should play an important role as a catalyst to generate an effective research programme. For these reasons, the funding of the MRC Unit in Glasgow should continue, particularly given its current focus on maternal and early years health. The Health Services Research Unit in Aberdeen has significant support for its capability building and could be asked to support research into patient feedback and addressing health inequalities.

In terms of developing joint initiatives in public health, Scotland should seek to collaborate not only nationally but internationally, at least within Europe. This will secure adequate sample sizes which can be difficult for Scotland alone even for relatively common disorders. Facilitating research would be an important attractor to Scotland of good researchers and foster further collaboration.

Finding ways to ensure that research structures, acronyms etc in this area of research relate to those in England will limit confusion among Scottish researchers and may help encourage investigators in Scotland to access NIHR resources.

4.2 Should CSO develop a Scottish initiative to support research for healthcare improvement? If so, what should be its focus?

A CSO initiative to support healthcare improvement research would be a valuable initiative, particularly if targeted at redesign or re-organisation of care, for which grant funding can be difficult. An important candidate for research would be better sharing of clinical databases between general practitioners and secondary care clinicians. Patients express astonishment that such systems are not already in place, and providing better exchange of clinical information would create an effective platform for healthcare improvement.

Experience from England suggests that their focus on disease oriented priorities has not been demonstrably effective, and this suggests Scotland should take a broader view.

4.3 Should programme grants be retained? If so, do the existing eligibility criteria remain appropriate?

The College has received mixed views on this issue. On one hand, this allows the research team to take forward several areas of related research and creates some stability but on the other hand, large amounts of resource are channelled towards one area of research to the detriment of others. There is a view that some programme could be better directed towards response mode grants that support projects likely to lead to the award of major grant funding from other external bodies. However, some programme funding (possibly for 5 rather than 3 years but with clear direction) could be awarded preferentially to those programmes likely to change practice materially and/or programmes that include research networks across Scotland. Where possible, these should be pan-Scotland programmes involving networks from at least the four major clinical centres. Programme grants for basic science should receive less favourable funding.

4.4 Should CSO change the current ceilings for response mode grants, potentially at the expense of the number of available awards?

As mentioned earlier, large projects require significant funding; indeed, it is extremely hard to do a multi-centre study involving a significant number of patients for less than £0.5m. Having said this, if infrastructure developments reduced the costs of multi-centre randomised trials significantly by providing core facilities and making it easier to recruit patients, then the situation might change. In the meantime, there will be very little “significant” research happening in Scotland until the ceiling for awards rises very significantly. It would still be important to maintain some portfolios of research to allow small pilot projects and other research can take place, but it is that the larger projects that will be of greatest benefit of Scotland.

4.5 What should CSO do to increase dissemination of research findings and foster uptake of research evidence into practice?

The translation of evidence into practice is in itself a process that lends itself to a research project to determine the best method of undertaking research. A more joined-up NHS might react better to changes in evidence and the CSO’s role might be to foster research into how to join up better the NHS. However, success in the uptake of research evidence will be influenced by the decisions taken on the balance of early and later translation research in the overall programme.

5.1 Beyond the three recommendations of the Data Linkage Workstream Group, what other steps are needed to ensure a streamlined, safe and robust system of providing access to linked health records for research?

A rather bizarre anomaly exists in that researchers anywhere in the UK can purchase an anonymised English database of healthcare resources that are already record linked and use this resource without any ethical approval or Caldicott Guardian approval! Indeed, the only constraint is that studies submitted for publication must be approved by a scientific advisory board. This database is the general practice research database (GPRD owned by the MHRA) and its size is roughly equivalent to that of the population of Scotland. Record-linkage has been the lynch-pin of Scottish research for many years, yet we have increasing bureaucratic and difficult process for accessing healthcare data in Scotland and record-linkage is nothing like Scotland-wide. The Scottish Health Informatics Programme needs to be supported to move forward with greater pace.

ISD, operating as a ‘bureau service’, should be able to record-link all data from general practice computers, from dispense prescribing data, from ISD SMR databases, from social care resources, from laboratory data etc into one record-linked resource which could then be anonymised and provided to researchers in Scotland on the same basis as GPRD. Such an investment would be relatively inexpensive, in that the data largely exists and all that needs to happen is for them to be record linked and anonymised. CSO should pay for this.

The GPRD system provides a system of validating data by going back to the database with queries about data. These can then be de-anonymised and resolved and then re-anonymised for the investigator.

The other issue is one of seeking the widespread consent of patients in Scotland for their patient-specific data to be used for research and it is unquestionable whether a significant majority would indeed consent. The two approaches to providing large, record-linked datasets are either to provide completely anonymised data to researchers or to provide researchers with data for which consent has been obtained (or indeed both). The maintenance of such databases could be provided by the NHS in the form of ISD. These databases could be made widely available to all researchers in Scotland. The availability of this resource will attract researchers to use it not only in the UK but from around the world.

5.2 Is the model outlined above, an appropriate one for developing data linkage infrastructure and capacity in Scotland? What else is needed?

One of the strengths of Scotland is that it is possible to explore nationwide studies and create a major database. This is increasingly becoming true of England and many other countries in Northern Europe. When the country is in effect a database, randomisation of persons, or practices within the healthcare system, provides a route to carry out efficient, low-cost studies with excellent external validity.

In order to carry out such studies, an efficient way of contacting patients needs to be developed. At present, consent to ask for consent is a difficult issue and usually involves asking primary care doctors to contact patients on behalf of researchers. Scotland needs a much more efficient way of seeking consent. Perhaps a central resource that records consent for consent would be one way forward.

The competing authority of a number of regulatory bodies concerned with data linkage has created confusion and sometimes contradictory approaches in Scotland. Creating a statutory role for the Privacy Advisory Committee of NSS (PIAG in England and Wales) would benefit observational research.

Scotland needs to improve the accuracy of ICD-10 and OPCS coding for inpatient and outpatient data.

5.3 Is the vision for a world class system of record linkage set out above a realisable one? Have we identified the key resource and governance issues that need to be resolved? If not, what other issues do we need to address?

See also the response to 5.1. Completely anonymous data need minimal governance and requiring no ethical approval for its fair processing to produce research findings that would benefit the NHS enormously. Whilst it is understood that data cannot be completely anonymous, acceptable anonymisation, and an undertaking by researchers that they will not try to decode individual patients, would provide the model that is required. A scientific advisory board constituted similarly to that of the GPRD would be all that was required before studies were published. Thus, any investigator in Scotland could have access to the database, the scientific rigor being that a scientific advisory board would quality control anything prior to it being published.

5.4 Have we identified the key tissue samples to be collected? How should access to such Scotland-wide resource be managed? Are there other issues that we need to address?

The Mayo Clinic in Rochester has routinely collected biological samples and data from its patients since its inception. Patients treated at the Mayo give consent for this to be done and Denmark has similarly created a nation-wide collection of biological samples, with clear and explicit access arrangements. Why is it not possible to replicate this approach in Scotland?

6.1 Research translation will be a key quality to judge when making personal ‘capacity building’ awards. Views on how this should be encouraged and achieved are invited

The College recommends that the CSO should focus on short-term translation (eg within a time horizon of 5 years) and leave long term to other bodies. Quality judgements may require input from scientific advisers from beyond the UK to deliver fair assessments, avoiding conflicts of interest. Wherever possible, committee meetings should be replaced by an objective scoring system and virtual decision taking.

6.2 What forms of postgraduate research funding provide the most beneficial basis to establish a research career?

The College recommends early recruitment to foster careers in research, and certainly before consultant appointment. Changes in medical training have shifted the emphasis away from research and it is no longer seen as an important prerequisite to getting a teaching hospital position. A significant disincentive to undertaking research is that major projects now take much longer than 2 years, with the result that researchers could be taken ‘out of clinical work’ for a considerable period of time. This conflicts with lifestyle choices for many young doctors, for whom short term career moves with no certainty about career progression is difficult. Pre-doctoral posts need not be tied to a particular centre or specialty, and post-doctoral posts need to ensure the balance between clinical and research components is appropriate to deliver research results. If we want researchers, we have to provide them with careers, stability and also reward success in some tangible way. Clearly, a research track that continues into the senior role would provide such a career path.

6.3 How might CSO best support the Action Plan for Healthcare Science in Scotland?

CSO needs to explore options for recognising additional research experience with tangible rewards when doctors are appointed to substantive posts. This would address the time/seniority disincentive for young doctors keen to participate in research.

6.4 The clinical professions are at very different stages in terms of research career path, how can academic training paths best be integrated into professional careers? Are there other approaches that might be more effective?

Modernising Medical Careers has discouraged many of the portfolio types of career that previously existed and now promotes a fast track to CCT. The research community would benefit from some flexibility to allow more consultants to participate in clinical research. Creating a generic curriculum, perhaps focusing on translation as has been tried in NIH in the USA, may be a cost-effective way of encouraging research by all clinical staff.

6.5 Are there areas of need that are unique to or uniquely challenging in Scotland?

One challenge in Scotland is its geographical diversity. For practical purposes, research is carried out in the main conurbations with limited opportunities in the more remote areas. The development of the IT infrastructure throughout Scotland should make Scotland-wide research more feasible and specific initiatives to create “virtual” research networks across Scotland would engage clinicians across Scotland. A research group with members in the different universities or hospitals would more equitably distribute funding across Scotland and might pool resources more effectively.

Scotland should develop its own research strategy, but it is important to set this in the context of research priorities, structures and funding mechanisms across the UK and beyond. Introducing greater complexity through new and separate mechanisms and procedures would not be welcome by the research community and could deter new entrants.

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939

[29 April 21 2009]