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Translational Workshop Report

20-21st February 2007. Latimer House, Bucks.

Executive Summary

In recent years, promoting and strengthening translational research has been a key priority for MRC. Following several specific initiatives, MRC agreed to step back, consider its progress in this area and discuss what more it should do to support the translational research process. Although focussed on MRC, following the publication of the Cooksey review of UK health research funding in December 2006 and its focus on translation, it was hoped that the Workshop’s recommendations could also inform discussions of the Office for Strategic Co-ordination of Health Research and the Translational Medicine Board.

MRC’s description of translational research was developed by its Clinical Research Advisory Group as:

“the process of the bidirectional transfer of knowledge between basic work (in the laboratory and elsewhere) with that of the person, in health or disease.”

Approximately 50 members of MRC’s community including industry and representatives from the Health Departments came together in February 2007 to discuss these issues. Delegates discussed the translational research process, MRC’s role and what more MRC could do. The main issues to emerge were the need for:

  • Cultural change within the research community and recognition that translating research findings and communicating findings to research users was part of a researcher’s role. Structures and funding mechanisms needed to be put in place to encourage and reward researchers to move into and become active in these areas.
  • Guidance on the process of translation and an accompanying vocabulary to describe more precisely translational activities. Process maps could be used to educate and assist researchers in identifying the next steps in progressing research findings and also provide metrics against which MRC could evaluate its process.
  • A separate funding stream to build capacity and provide project support for early translational research (e.g. experimental medicine; biomarkers; proof-of-concept studies). Where possible, these new initiatives should be undertaken through partnerships with industry.
  • MRC’s should continue to build on its high quality basic research portfolio but a much greater focus must be placed on the management of the findings from MRC funded research. Resources needed to be provided for the proactive brokering of partnerships between researchers and research users and for catalysing bottlenecks in the process in order to facilitate translation.

Introduction

Accelerating the translation of biomedical research is a key priority for the Medical Research Council (MRC) and over recent years MRC has funded a number of initiatives to support and strengthen this area as well as encouraging translational research through the intramural programme and investigator-led grant support.

MRC’s description of translational research was developed by the MRC Clinical Research Advisory Group, which developed MRC’s strategy in clinical, translational and public health research in recent years. MRC describes translational research as

“the process of the bidirectional transfer of knowledge between basic work (in the laboratory and elsewhere) with that of the person, in health or disease.”

Mid-way through 2006 and following a number of specific initiatives, MRC decided to step back, review its progress and consider what more it needed to do to support the translational research process. In addition to considering its support of research projects, MRC also wished to consider its support of knowledge transfer.

The purpose of the Workshop was to consider MRC’s role in translation and what more it could do to support translational research proposals and knowledge transfer activities, however following the publication of the Cooksey review in December 2006, it was hoped that the recommendations from the Workshop would also inform discussions within the newly established Office for the Strategic Co-ordination of Health Research (OSCHR) and its Translational Medicine Board.

Issues for consideration at the Workshop

The programme for the Workshop is provided in Annex 1 and the list of Workshop attendees in Annex 2. The delegates included Council members, MRC Research Board members and MRC stakeholders and partners from industry and the Health Departments. During discussion sessions, delegates were asked to address the following issues:

1. What are the processes involved in translation (and the relative role of translational research and knowledge transfer)?

2. What are the MRC portfolio’s strengths/weaknesses with regards these processes and why?

3. What should MRC do to further support and assess translational research and knowledge transfer activities with respect to:

a) new initiatives to better support and strengthen gaps/weaknesses in these areas

b) modification of existing mechanisms (support available, assessment criteria, peer-review process)

4. What metrics might be used to monitor MRC’s achievements in this area?

These discussion sessions were supplemented by presentations from Professor Colin Blakemore, Chief Executive of MRC on its translational research initiatives (Annex 3), from Dr Ernest Hawk of the US National Cancer Institute on its ongoing review of its support for translational research (Annex 4) and from Dr Ian Graham of the Canadian Institutes of Health Research on its strategies and initiatives in knowledge transfer (Annex 5).

Summary of the main issues emerging from the Workshop

General issues - the National Picture

To strengthen the national translational research portfolio, there needs to be a cultural change amongst researchers plus new and stable forms of funding to encourage researchers to move their research along the translational pathway over the longer-term.

Translational research requires interdisciplinary skills and expertise. The current academic research environment does not encourage collaborations across disciplines both within the biomedical sciences and across to the engineering and physical sciences.

Research capacity in translational research and the disciplines/skills that underpin it (e.g. physiology, pharmacology and toxicology) needs to be increased and strengthened.

The career structure for translational scientists, particularly those who were clinically qualified, needs to recognise the outcome-focus of translational research and should not prejudice against not publishing in high quality journals.

Any significant additional investments in this area should build upon existing investments in infrastructure (e.g. the Wellcome Trust Clinical Research Facilities, NIHR Biomedical Research Centres, MRC Units/ Institutes etc).

The research environment in academia does not encourage knowledge transfer. This type of activity is not supported generally by major research funders and is not recognised in the RAE process.

1. What are the processes involved in translation (and the relative role of translational research and knowledge transfer)?

The terms, translation and translational research are poorly defined and often used to describe a broad range of very different research studies (e.g. biomarkers; experimental medicine, early phase II trials etc, uptake into policy and practice). The research community and research funders need to be more precise in their description of these activities.

Translational medicine was the term suggested to describe the process from basic research findings to clinical studies in humans. It was suggested that translational medicine was principally a unidirectional rather than a bidirectional process.

Delegates welcomed the NCI Pathways to Clinical Goals which outlined the translational research process. It was suggested that such route maps, as well as the development of an accompanying vocabulary to better describe the process of translation, would be useful in both encouraging grant applicants to consider the customers of their research and providing guidance for researchers on how to take research findings to the next step in the translational process.

Like translational research, there needs to be clarification of the definition of knowledge translation as it can be used to describe a variety of activities such as applied health research, dissemination, knowledge exchange, knowledge management and implementation translational research.

Translational research needs managing. Currently the skills and expertise required to facilitate translation and manage its progress are limited in the UK academic environment. The expertise available needs to be capitalised on and developed in for the future.

Research funders need to monitor more closely their investments in translational medicine in order to enable rapid recycling of funds if these often costly projects do not reach agreed objectives or milestones.

2. What are the MRC portfolio’s strengths/weaknesses with regards these processes and why?

Delegates agreed that the MRC brand was associated with excellent high quality basic research and that this should continue to be its focus.

MRC did have a successful history in translating biomedical research and there were many examples both from the intramural and extramural programme.

MRC should continue to build on its initiatives in early translational research i.e. between exploratory research and phase II studies.

Delegates considered that this did not require a significant change in the pattern of MRC funding but rather better co-ordination and exploitation of its existing activities.

MRC should build on the expertise and resources provided to the intramural programme through MRCT by extending this support to the extramural programme.

The current MRC scoring system was one-dimensional and focussed on quality and importance/innovation. This biased the peer-review process in favour of blue-skies/basic research compared to translational research where the focus was on potential payback.

3. What should MRC do to further support and assess translational research and knowledge transfer activities

With respect to:

a) new initiatives to better support and strengthen gaps/weaknesses in these areas

b) modification of existing mechanisms (support available, assessment criteria, peer-review process)

  • MRC should raise the profile of its commitment to translational research to facilitate the cultural change required in the research community to progress research findings towards clinical benefit. The NCI Pathways to Clinical Goals were viewed as useful tools to educate the research community about the translational process.
  • MRC should identify where its efforts are best placed with regards translational research and knowledge transfer activities.

Aspects of translational research, particularly early phase studies as well as phase III effectiveness trials are relatively expensive and resource intensive (e.g. CR UK has >60 staff to maintain 30 projects funded through its New Agents Committee). MRC should consider where its investment is best placed, what level of investment is appropriate and achievable, and where the potential payback is greatest e.g. in specific parts of the translational process, in connecting existing translational activities or by focussing on specific health priorities.

MRC should also look to broker new partnerships with industry to support its translational research agenda particularly in areas of mutual interest.

It was suggested that MRC focus on establishing and facilitating better connections between the existing components of the translational process that were already in place nationally.

3a) New initiatives

Early Translational research (or translational medicine) needs a separate funding mechanism because it is not always competitive on either outcomes or cost when compared to basic or clinical research.

There was no consensus on the model for this new funding route; it could comprise of separate funding Committees for discrete parts of the translational process (e.g. as at CRUK); general follow-on funding to MRC grantees (e.g. as at BBSRC) or through calls for proposals (e.g. as with MRC experimental medicine and biomarker initiatives). With regards the latter, delegates emphasized the importance of a regular and sustained funding stream in order to develop critical mass and a high quality research portfolio in specific areas.

It was agreed that any new process needed to include a more iterative discussions with applicants.

  • New initiatives to build research capacity in translational research. e.g. the next generation of clinical leaders, more interdisciplinary researchers or those that span the academic/industry and academic/clinical interfaces.
  • Translational research fellowships might need to be extended beyond 3-year awards to enable students to train in some aspects of translational medicine e.g. early phase trials.
  • • Better support of interdisciplinary research; perhaps through new training schemes (above) or addressing specific gaps or projects with dedicated funding (e.g. ESPRC sandpit scheme)
  • • Greater oversight/management of the MRC research portfolio is required to better exploit exciting discoveries into new healthcare products.

Although there were some issues around the issue of IP ownership, extending the support and expertise provided by MRCT to the extramural programme would be very attractive to University researchers.

Communication was key to the translation process. There needed to be better information and dialogue between basic and translational researchers

MRC should be proactive in brokering and catalysing bottlenecks in the translational process in order to facilitate translation. This could be between academic groupings within medicine and across to the engineering or physical sciences, industry and/or NIHR. It was suggested that this role could be located centrally as Head Office had the overview of the whole portfolio and wider strategic connections in order to broker such collaborations.

The professional societies could also be encouraged to play a greater role in knowledge translation.

MRC should raise the profile of knowledge transfer. This would support the cultural change required in the research community that tailoring the communication of research findings to stakeholders was part of the research process and their role in it.

MRC should strengthen its knowledge transfer activities in order to proactively manage its research portfolio and catalyse bottlenecks in the translation process.

How this might be achieved was discussed and several models were proposed. Facilitating knowledge transfer could either be a function within MRC Head Office or by embedding knowledge brokers in research centres. The latter could continue to be done in-house (MRC research translators), using external expertise (from venture capital, industry); or an Expert group of eminent translational researchers to assist/trouble shoot promising discoveries from MRC research.

3b) Modification of existing mechanisms

Applicants should consider and be assessed on the translational potential of their proposals. Although the difficulty in recognising the “winners” was noted, there was agreement that this endeavour should be pursued and applicants to MRC should be asked to address, at the time of funding, how they planned to translate their research findings.

To assess this, MRC Research Board membership and/or the peer-review process might need to be supplemented and include “customers of MRC research”

Although on the whole, translational research requires a separate funding mechanism, this type of research was often included alongside basic/exploratory research in MRC Research Grant applications and this should be encouraged.

Where required, MRC should supplement its Board memberships with additional expertise e.g. either from interdisciplinary researchers, industry or other stakeholders.

MRC should review and assess the outcomes of the research it funds (as done by ESRC and NCI) not just individual grant applications at the time of funding.

4. What metrics might be used to monitor MRC’s achievements in this area?

Delegates agreed that they did not have sufficient time to consider this issue in detail. It was suggested that MRC establish a Working Group to study this area and develop metrics of both outcomes and surrogate measures for down-stream outcomes. The NCI Pathways to Clinical Goals could be used to define the translational process and also to identify progress.

Case studies of successful and non successful translation would be useful to identify metrics.

Annexes

This report, with full Annexes is available from the MRC website

  • Annex 1 Workshop programme
  • Annex 2 Workshop participant list
  • Annex 3 Professor Colin Blakemore (MRC) presentation - Translational research – MRC initiatives and priorities
  • Annex 4 Dr Ernest Hawk (NCI) presentation - Harnessing Discovery for Patient & Public Benefit – NCI’s Approach to Fuel Translational Progress Annex 5 Dr Ian Graham (CIHR) presentation - Knowledge Translation at CIHR

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