Changing the Translational Research Landscape

Short abstract

Describes a review of the NIHR Biomedical Research Units scheme. This review was a perceptions audit of senior executives involved in the scheme, and explored what impact they felt the scheme is having on the translational research landscape.

Abstract

This article describes a review of the Biomedical Research Units (BRU) scheme, undertaken for the Department of Health. This review was a perceptions audit of senior executives involved in the scheme, and explored what impact they felt the scheme is having on the translational research landscape. More specifically, we investigated whether and how institutional relationships between NHS and academic partners, industry and other health research system players are changing because of the scheme; how the scheme is helping build critical mass in specific priority disease areas; and the effects of any changes on efforts to deliver the broader goals set out in Best Research for Best Health. The views presented are those of study informants only. The information obtained through our interviews suggests that the BRU scheme is significantly helping shape the health research system to pursue translational research and innovation, with the clear goal of realising patient benefit. The BRUs are already contributing to observable changes in institutional relationships between the NHS and academic partners: trusts and medical schools are collaborating more closely than in the past, have signed up to the same vision of translational research from bench to bedside, and are managing and governing targeted research resources more professionally and transparently than in the past. There is also a stronger emphasis on engaging industry and more strategic thinking about strengthening regional and national collaboration with other hospital trusts, PCTs, research organisations, networks and development agencies. The scheme is also transforming capacity building in the health research system. This includes (i) developing and modernising facilities and equipment for translation; (ii) building a critical mass of human resources through recruitment and training, as well as improving retention of existing expertise; and (iii) helping ensure a steady flow of funds needed to sustain research activity and accelerate movement through the innovation pipeline. A number of centres are also trying to recreate the BRU model in new disease areas, with their own resources.

Study Context and Findings: The Highlights

BRUs Have an Important Role to Play in the Emerging Health Research Landscape Following Best Research for Best Health

1. Biomedical Research Centres and Biomedical Research Units as flagships in initiatives of Best Research for Best Health: In January 2006, the Department of Health's Best Research for Best Health* strategy (BRfBH) set out to create a health research system in which the NHS supports outstanding individuals, working in world-class facilities, to conduct leading-edge research focused on the needs of patients and public. Two of the flagship initiatives of BRfBH were the establishment of Biomedical Research Centres (BRCs) and Biomedical Research Units (BRUs). These are both partnerships between an NHS trust and a university. They share a common goal to undertake translational research in priority areas of high disease burden and clinical need, and to provide a significant contribution towards realising the broader ambitions set out in BRfBH. While the BRCs are about “making the best even better," the BRUs aim to be “building on the best.”** The term “building” refers to the “developmental role” sought for BRUs—in developing new relationships, greater capacities and improved targeting, and an enhanced responsiveness in health research.

2. The specific goals of Biomedical Research Units: BRUs were established after BRCs. Through the BRU award, the NIHR aims specifically to assist the further development of NHS and university partnerships which are at the forefront of their field internationally (but relatively small and specialised in comparison to the larger BRCs), to achieve critical mass. The awards should enable the partnerships to further strengthen research capacity in a priority area so that they are capable of submitting a credible bid for BRC status in the future. The BRU scheme supports priority research areas which are under-represented in the BRC portfolios and in which the UK has recognised research strengths. They include cardiovascular disease; deafness and hearing problems; gastrointestinal (including liver) disease; musculoskeletal disease; nutrition, diet and lifestyle, and respiratory disease. Twelve BRUs were awarded in April 2008, a further three in July 2008, and the final award was made in April 2009.

3. Remit of the study: This article describes a review of the BRU scheme, undertaken for the Department of Health. This review was a perceptions audit of senior executives involved in the scheme, and explored what impact they felt the scheme is having on the translational research landscape. More specifically, we investigated whether and how institutional relationships between NHS and academic partners, industry and other health research system players are changing because of the scheme; how the scheme is helping build critical mass in specific priority disease areas; and the effects of any changes on efforts to deliver the broader goals set out in Best Research for Best Health. The views presented in this report are those of study informants only.

4. Caveats of the study: It is important to understand that this review was conducted at an early stage of BRU existence: in most cases the BRUs are just over one year old.*** The BRUs are intended to be responsive and to evolve in the light of developing opportunities and therefore this report offers only a “snap-shot” in time. This means it is too early to assess downstream outputs from BRU activity, such as research papers, new diagnostics, treatments or changes in health policy. In addition, we interviewed the most senior executives of BRUs and so it represents a snapshot from a particular (albeit very well-informed) viewpoint. A more detailed perceptions audit would benefit from investigating the views and experiences of other participants in the initiatives, including academic researchers and clinicians engaged in research projects, and NHS managers. We are also aware that interview-based evidence collection can be subject to deliberate or unintended biases resulting from the position and experiences of the interviewees. However, we consistently tried to get evidence and examples from interviewees, to support interviewees' views and claims. The fact that there was a broad consistency in the accounts different stakeholders produced (i.e. university and trust representatives) gives us further confidence that on balance interviewees gave dispassionate and complete accounts of where BRUs stand, and how they have evolved since they were set up. Lastly, whereas our review gathered interviewee perceptions on the changes the scheme is bringing about, we did not have a counterfactual. Therefore, although we could explore the value of the BRU scheme, we could not assess the value added, in comparison to translational research efforts being pursued by trusts and academic organisations without BRU status. In summary, the broadly very favourable account of the developing role of BRUs which we were given, and report here, should not in itself be taken as compelling proof that the BRUs are delivering all that is hoped of them in relation to boosting patient health and national wealth. These caveats should be borne in mind when drawing conclusions from this study.

5. BRU impacts—key findings: The information obtained through our interviews**** suggests that the BRU scheme is significantly helping shape the health research system to pursue translational research and innovation, with the clear goal of realising patient benefit. The BRUs are already contributing to observable changes in institutional relationships between the NHS and academic partners: trusts and medical schools are collaborating more closely than in the past, have signed up to the same vision of translational research from bench to bedside, and are managing and governing targeted research resources more professionally and transparently than in the past. There is also a stronger emphasis on engaging industry and more strategic thinking about strengthening regional and national collaboration with other hospital trusts, PCTs, research organisations, networks and development agencies. The scheme is also transforming capacity building in the health research system. This includes (i) developing and modernising facilities and equipment for translation; (ii) building a critical mass of human resources through recruitment and training, as well as improving retention of existing expertise; and (iii) helping ensure a steady flow of funds needed to sustain research activity and accelerate movement through the innovation pipeline. A number of centres are also trying to recreate the BRU model in new disease areas, with their own resources.

6. Similarities and differences between the evolution of BRUs and BRCs—a high-level reflection: Many of the impacts and key messages we identified through this review of BRUs, also apply to the BRC scheme. However, the emphasis is somewhat different and related to the distinction between “building on the best” and “making the best even better.” For example, staff in many BRU locations have never had access to translational research funding of this nature or scale in the past, and for them the experience has been transformative. BRU directors are also very enthusiastic about having their own translational research patches to grow, and this enthusiasm has spilt over into capacity building efforts, and their keenness and commitment to engage with industry and other partners (including PCTs).

We elaborate on these key impacts, based on the perceptions expressed by those we interviewed, and present examples that were given in support of their views in the following sections.

Reflecting on Specific Areas of Impact

Brus Are Contributing to Positive Changes in Institutional Relationships Between the NHS, Academia, Industry and Other Stakeholders in the Health Research System

1. NHS–academia relationships: The BRU scheme has placed the spotlight on translational research for patient benefit. Respondents noted that NHS and academic partners are collaborating more closely than in the past, to undertake research aimed at improving patient health and the general well-being of the public. The attitudes and mind-sets of NHS and academic staff towards mutual collaboration are changing, and there is both more interest in collaboration and more opportunities to jointly take research forward. New organisational structures, divisions and functions have been established to facilitate translational research and ensure the transparency and accountability in the management and governance of BRU funds. NHS and academic stakeholders are also improving their ICT infrastructure to facilitate more effective communications. These changes are all a reflection of a more business-like approach to research and commitment to ensuring clear lines of responsibility and accountability for the initiatives. It is widely felt that there is a lot more professionalism in managing research as an integral and important business activity of the trust, and within academia–trust partnerships. The allocation of research resources is better targeted and matched to clinical needs than in the past. The process of applying for BRUs played an instrumental role in the establishment of better coordinated and more strategic approaches to translational research collaboration than existed in the past. (Overall, collaboration was seen to be historically less strategic and significantly more ad-hoc than it is today.)

2. Engaging the private sector: Our interviews showed that collaboration with industry is also higher up on the agenda of trusts and medical schools than in the past, and there is already some evidence of positive responses to the BRU initiatives from the private sector, and signs of new collaborations emerging. The NIHR expects BRUs to collaborate with industry to deliver health innovations, and central government is also promoting the importance of public–private sector relationships in biomedical and health R&D, for contributing to UK's economic competitiveness. In addition, challenges to retaining industry in the UK (due to issues such as the costs and bureaucracy associated with clinical research, difficulties in recruiting patients into trials, and increased competition for private sector presence from emerging markets such as China and Eastern Europe) have led academic organisations and trusts to become more strategic about what they can do to establish a research, operational and regulatory infrastructure that can add value to industry for the long term (not in the least in terms of the quality and reliability of services offered).

3. Regional and national linkage and exchange: BRUs are also adopting a more strategic approach to engaging other regional and national organisations in efforts to move research from bench to bedside. This includes academic institutions, hospital trusts, PCTs, clinical research networks and other NIHR initiatives such as BRCs and Collaborations for Leadership in Applied Health Research and Care (CLAHRCs). In some cases, disciplines outside medical schools are also being included in BRU activities. Many hope this will enable more interdisciplinary and innovative approaches to addressing translational research challenges. Lastly, actions to increase patient and public involvement in translational research are central to all BRU strategies, and community outreach activities are gradually becoming more comprehensive.

BRUs Are Supporting Capacity Building in Health Research

1. A holistic approach to capacity building: One of the most significant impacts of the BRU scheme is seen in how it is transforming capacity building in the translational research landscape, through contributions to (i) improving the physical infrastructure required for moving research from bench to bedside, (ii) building up a critical mass of leading researchers capable of advancing translational research agendas over the long term, and (iii) ensuring a steady flow of funds needed to sustain research activity and accelerate movement through the innovation pipeline.

2. Physical infrastructure: A very significant contribution of the scheme has been the support it has provided for securing facilities and equipment. For example, BRU funding is enabling the establishment of clinical research labs, the development of imaging capacity, patient databases, bio-repositories and tissue-retrieval banks. New physical space and equipment dedicated to translational research is bringing biomedical and clinical researchers much closer together than in the past, and facilitating more intensive communications that are expected to accelerate research translation.

3. Building critical mass: The status the BRU award provides, along with improved physical infrastructure, is increasing the attractiveness of BRU environments for people interested in translational research, and is helping recruit better expertise, both nationally and from overseas, than might have been possible without the scheme. Although many interviewees felt that it was too early to provide concrete evidence of the impacts of the scheme on staff retention, in two cases we were told that it is now easier to persuade people to stay at BRU locations because of the new and exciting prospects the units offer in terms of their career development. BRU funding is also being used to provide clinicians with designated research time in their job plans. We were also told that research experience and interest now weighs more heavily in decisions to hire NHS consultants.

4. Training: NIHR funding for BRUs is also enabling the training of future translational research leaders, and is making a particularly important contribution towards opening new opportunities for NHS clinicians to be trained in and/or engage in research activity, in a more structured manner than in the past. The training opportunities created via the scheme are complemented with support from other institutions nationally (e.g. research councils and charities). Some interviewees also felt that the take up of research training opportunities by clinicians is increasing, because the BRU has had a significant influence of elevating interest in translational research.

5. Leveraging additional funding: Many BRUs have also highlighted the positive effects of the initiative on obtaining funding from external sources (e.g. charities and industry). The scheme has also influenced trusts and universities to commit additional funds in support of BRU aims. In some cases, trusts are pursuing the development of BRU-like arrangements in new research areas which they wish to strengthen, supporting these from their own resources and with additional contributions from university partners.

BRUs Are Part of Improved Resource Targeting, Management and Governance in the Health Research System

1. The BRU scheme has helped in transforming the way research resources are managed and governed in the NHS: It is widely felt by those we spoke to that there is a lot more professionalism in managing research as an integral and important business activity of the trust, and within academia–trust partnerships. The allocation of research resources is better targeted and better matched to clinical needs than in the past. New structures such as joint research offices shared by academic and NHS partners and translational research steering committees are facilitating the pursuit of common agendas between universities and the NHS, and are ensuring greater transparency and probity in the allocation and monitoring of spending, and in the monitoring of progress and performance. Joint R&D offices are also providing administrative support to improve the efficiency and reduce the bureaucracy that accompanies translational research. BRU leaders feel that it is essential that individuals with administrative responsibilities are appropriately trained in business and administration processes, rather than being placed into such positions from a pure academic or clinical background.

BRUs Are Still Learning and Adapting in the Face of a Changing Environment

1. Learning and experimentation: As is the case with most complex new initiatives, BRUs have been a learning experience for those involved. Integral to the learning process has been an effort to identify and implement the financial, administrative and regulatory arrangements for BRUs that are best fit for purpose. Trust and university stakeholders have devoted significant time and effort to find efficient ways of managing the flow of funds between partner organisations, establishing common science commercialisation principles, and finding creative ways to minimise the bureaucracy associated with research regulatory processes.

2. Networks and platforms for interactive and collective learning: The process of setting up BRUs has led NHS and university stakeholders to identify some areas where improved communication systems and infrastructures could help further increase the efficiency and long-term impact of the initiatives. Suggestions to establish an online forum to enable a more effective support network between BRUs throughout the country, as well as between BRUs and BRCs, were made. This would provide a platform for more frequent discussions, exchange of information and the sharing of best practice.

3. Interactions with the NIHR: Frequent engagement and transparent dialogue between the NIHR and those it funds was thought to be important for making optimal use of the resources and opportunities available in the health research system. There was widespread enthusiasm and support for the way the NIHR has supported and engaged with BRUs. Many trust chief executives, deans and directors emphasised the accessibility and open dialogue they have experienced with the NIHR. One area where further interaction would be beneficial revolves around achieving an improved clarity on different NIHR initiatives and their relationships, as well as funding streams and eligibility criteria. Although BRU leaders are aware that information on each of the new efforts is available in the public domain, many feel that it would be helpful if it could be presented in a somewhat more user-friendly and amalgamated format (such as a handbook or set of guidelines). Continued dialogue will also be important with respect to BRU renewal round criteria and specifications for the next round of BRC bids.

4. The wider underpinnings of successful BRUs: BRUs operate within a wider context that influences the supply of resources for research and the demand for research to inform policy and practice. Attending to their stability and sustainability, and mitigating some of their uncertainties, will also support the success of the BRUs. Interviewees identified a number of such broader policy-related issues regarding the future of the UK health research system and the evolution of their units. These included ensuring that the UK health research system is attractive to industry; planning for economic and political uncertainties; ensuring the most appropriate balance between concentration of resources and diversity; nurturing and strengthening opportunities for nurses and allied health professionals to be included in the health research system; and implementing and nurturing a fit for purpose performance evaluation framework.

5. Lastly, BRUs are part of an ongoing and larger effort, which includes other flagship NIHR initiatives such as BRCs and CLAHRCs, as well as other government initiatives such as Academic Health Science Centres (AHSCs), to create a sustainable, effective heath research system in which research is driven by the needs of patients and the public. The enthusiasm and commitment of leading figures within BRUs is evident from this report. There is a widespread agreement among interviewees that BRUs can make a positive contribution to the health research system in the UK and that they are already changing institutional relationships between the NHS, academia and industry. They are building capacity and are part of efforts to improve resource targeting and governance in health research.