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Guidance on the managed recovery of the UK clinical research portfolio

 

Contents

Purpose

The purpose of this paper is to guide the managed recovery of UK clinical research to enable restoration of a balanced portfolio.

The key aims of this framework are to:

  • explain why a managed recovery approach is required
  • set out the operational plan to achieve a managed recovery of the UK clinical research portfolio
  • provide guidance and criteria to assist in the application of this plan

Introduction

The impact of the pandemic on non-COVID research has been significant. Commercial sponsors are seeking increased certainty about when research delivery and the care services upon which they rely will be able to restart and deliver levels of activity needed to contribute to global studies. Non-commercial funders are facing similar challenges and increased costs as studies are delayed and amended. NHS sites are also seeking to recover research activity and generate the income needed to maintain our expert research delivery workforce into the future, while also supporting their staff as they recover and rebuild.

In order to support a sustainable UK-wide recovery, and in response to feedback from partners and stakeholders, a managed approach to the recovery of the UK clinical research portfolio is being implemented. The approach has been developed through the UK Clinical Research Recovery, Resilience and Growth (RRG) Programme with input from a broad range of stakeholders including funders, sponsors, NHS R&D, and patient and public representatives, as summarised under Governance below.

This guidance intends to provide a broad set of principles to manage the recovery of a balanced research portfolio over the next 6-12 months. It recognises the need to recover both individual sites’ capacity for research and collective capacity at regional and national level. It recognises the challenges being faced by NHS R&D and research delivery teams, who have made a critical contribution to the national and global effort to tackle COVID-19, and seeks to support them in managing the evolving situation on the ground and their own wellbeing. It also recognises that the delivery of care and research has been irreversibly changed during the pandemic, with new care pathways in particular necessitating new approaches.

This guidance calls for a coordinated effort across all partners to support the recovery of the portfolio in the national interest. It is only by enabling the whole system to recover that we will restore confidence to place studies in the UK and the capacity to deliver them. This time-limited managed recovery aims to speed up that process and build on the partnerships and collective action which enabled our collective success over the last year.

Background

There are over 6,000 studies on the NIHR Clinical Research Network portfolio, comprised of interventional and observational, single and multi-site, commercial and non-commercial studies across a broad range of clinical specialties. It is our intention that this rich and balanced portfolio is restored.

In order to achieve this, the managed recovery approach seeks to coordinate and sequence delivery of a sub-set of multi-centre studies while enabling sites to manage the delivery of their wider local portfolio, in particular single centre studies. Studies which are already open and recruiting successfully should not be paused as a result of this process.

Studies will be sequenced based on a combination of funders’ assessment of the relative urgency of their portfolio and assessment of site, regional and national capacity and capability to deliver them. Studies of national importance to each of the Devolved Administrations will also be included in the process.

By providing details of the most urgent studies for recovery, our intention is that this focuses available resources – particularly those funded through NIHR CRN and its Devolved Administration equivalents – where it can have the greatest impact.

We anticipate this managed recovery will continue for a limited time period of around 6 to 12 months. Sequencing of the first tranche of studies will be completed by June 2021, with further rounds occurring until the system has fully recovered. Lists of sequenced studies will be shared with stakeholders and partners as they become available.

This paper provides high level guidance on the criteria for the sequencing of studies and the roles and responsibilities of all partners in this process and does not intend to be prescriptive to every situation or study. It is our intention that this guidance will be reviewed and updated on an ongoing basis as the situation fluctuates due to the pandemic and recovery of research and care services.

The partnerships and collaboration which enabled our success during the pandemic will again be vital as we recover from it. To enable this, the managed recovery approach will be coordinated and led by NIHR CRN and overseen by the UK Clinical Research RRG Programme Board with ongoing support and feedback provided through the RRG Advisory Group. Stakeholders should communicate any questions or concerns through there representative bodies sitting on any of the above Boards or Groups. Further details are provided in Appendix A.

COVID-19 research

The transition of Urgent Public Health studies onto the wider NIHR CRN portfolio has begun. By the end of May 2021, COVID-19 studies will be treated as a speciality alongside others as part of a diverse portfolio. This specialty will be overseen by CUE-TIP, the COVID-19 Understanding and Elimination - Trials Implementation Panel, which will draw on the priorities identified by the Vaccines, Therapeutics and Antivirals Taskforces, oversee the delivery of the COVID portfolio, and be an escalation point for any challenges these studies encounter. Delivery of COVID-19 studies, including follow-up of participants in vaccines and platform trials, will be managed as part of the overall portfolio of research.

Scope of managed recovery

The primary focus of this approach will be interventional, multi-site clinical research studies that are both urgent and should benefit from the support of NIHR CRN and its Devolved Administration equivalents to enable them to fully recruit and/or close in the next year. We appreciate that particular specialties and funders may need a different approach and we are open to a more flexible approach where appropriate.

Studies which are already open and recruiting successfully should not be paused in anticipation of, or as a result of, this process. Other studies which fall outside of the primary focus should continue to be managed as usual by local sites. Where sites still have capacity for some studies that do not compete for resources or support, proportionate and pragmatic local decision-making can continue to enable such research to be supported. Special consideration may be considered locally for research supporting early career researchers who have limited time to complete their funded clinical research.

Initially, new studies will be considered only if the case for urgency is compelling amongst the list of sequenced studies. If a new study is sufficiently urgent to warrant selection, this should be raised with the NIHR CRN for consideration.

Summary of approach

At a high level, the approach is as follows:

  1. Funders and Devolved Administrations identify their most urgent studies
  2. NIHR CRN, working in partnership with NHS R&D and Devolved Administrations, assess site, regional and national (UK) delivery capability
  3. As studies are assessed, lists of deliverable studies are ratified and confirmed
  4. Any significant deliverability challenges communicated back to the Funder/DA
  5. As and when the first series of studies is recovering towards normal recruitment, further rounds of study listings will be completed
  6. NIHR CRN National Specialty Leads will cross-check specialty portfolios and identify further studies to ensure a balanced portfolio

Criteria for sequencing of studies

Commercial and non-commercial funders are being invited to submit a list of studies to be first in the sequence for recovery. In the first tranche, funders with the greatest number of studies on the NIHR CRN portfolio have been included, and this will be widened in further rounds. The Devolved Administrations have also conducted a review of their portfolios to identify any studies of national importance.

To guide funders’ decisions, the following criteria should be applied to identify the first tranche of studies:

  • already open or in set-up
  • multiple number of sites involved
  • urgent, as the research questions are key to the NHS and wider health evidence and policy or the study provides access to potentially life preserving or life-extending treatment not otherwise available to the patient
  • due to close within the next 12 months or studies with a key delivery timeline in the near future
  • track record of reasonable delivery but judged to benefit from focused support

As noted above, we are open to a more flexible approach and dialogue to assess suitability of studies which fall outside of these criteria where appropriate. However, the intention is to focus on recovery of this key sub-set of the portfolio in the first instance.

Commercial funders

NIHR CRN, on behalf of the UK, have begun discussions with industry partners to identify their top 5 studies and will work with them to manage the recovery of those studies over the coming months.

In the first tranche, funders with the greatest number of studies on the NIHR CRN portfolio have been included, and this will be widened in further rounds.

Non-commercial funders

Working in partnership with the Association of Medical Research Charities (AMRC), NIHR and UK Research and innovation (UKRI), funders have been invited to list a proportion of their portfolio, based on its size, to determine the first tranche of non-commercial studies:

Overall number of multicentre studiesProportion to select
50-100 studies 20%
10-49 studies 15%
0-9 studies 1 study

In the first tranche, funders with the greatest number of studies on the NIHR CRN portfolio have been included, and this will be widened in further rounds.

Assessment of deliverability

NIHR CRN will work in partnership with NHS R&D and the Devolved Administrations to assess deliverability of the studies listed by funders at site, regional and national (UK) level. The detailed process will be iterated as it is implemented, responding to operational needs as they arise. Further information on the process can be accessed through local NHS R&D departments and Local Clinical Research Networks (LCRNs).

Governance

The managed recovery process has been developed and will be delivered through the UK Clinical Research RRG Programme. NIHR CRN is leading implementation on behalf of the UK and has established a UK-wide Operational Group to manage the process.

The operational group reports into the RRG Programme Board, which in turn reports to the RRG Oversight Group. Membership of the Boards and Groups involved in this process are provided in Appendix A.

Stakeholders and partners are encouraged to communicate any questions or concerns through their representative bodies and to participate in engagement and feedback opportunities to help us ensure the process is fit for purpose both in its implementation and as the practical realities evolve.

Appendix A: RRG Programme Governance groups

Managed Recovery Operational Group

The Operational Group is comprised of the operational leads within the NIHR Clinical Research Network and Devolved Administrations, and representatives from NHS R&D (UKRD).

RRG Programme Board

Purpose: Provide oversight and coordination across organisations of the implementation of the RRG strategy and associated plans, comprising key national activities across the UK.

Membership: The Board is Chaired by the Department of Health and Social Care (DHSC) Director of Science Research and Evidence. The Board includes senior responsible owners of the actions which comprise the RRG strategy and associated plans in England, including NHS England and NHS Improvement, the Office for Life Sciences, NIHR, Health Research Authority, Medicines and Healthcare Products Regulatory Agency, NHSx, NHS Digital, representatives of the Devolved Administrations responsible for aligned programmes of work, co-chairs of the RRG Advisory Group and representation from the med-tech and diagnostics industry.

RRG Advisory Group

Purpose: Provide advice, support and guidance to the Programme Board.

Membership: The Group is co-chaired by the Association of the British Pharmaceutical Industry (ABPI) and Association of Medical Research Charities (AMRC). The Group includes representatives from:

  • industry, including the Life Science Council’s Clinical Research Working Group (CRWG) and life sciences trade association members
  • AMRC member charities
  • patient and public representatives
  • UK Research and Development (UKRD)
  • NHS R&D Forum
  • University Hospitals Association
  • representatives of the research delivery workforce across NHS settings
  • Royal College of Physicians
  • UKCRC CTU Network
  • Medical Research Council
  • NIHR Programmes, BioMedical Research Centres, Clinical Research Facilities and Local Clinical Research Networks
  • NHS England and Improvement Regions

Where these organisations are not UK-wide, members also include their equivalents in the Devolved Administrations.

RRG Oversight Group

Purpose: Oversee the programme, taking decisions on strategic priorities and ensuring strategic coordination across programme partners.

Membership: The Group is be chaired by the DHSC Minister for Innovation. The Group includes CEOs/Directors of RRG Programme partners, senior representatives from industry, research charities, the NHS and Academia, patient and public representatives, and the RRG Programme Board Chair and Programme Lead.