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Advanced Fellowship: Building clinical trials experience

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Published: 04 April 2023

Version: 1.0 March 2023

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MRC-NIHR funding collaboration

Introduction

The MRC-NIHR Efficacy and Mechanism Evaluation (EME) Programme and the NIHR Fellowships Programme are keen to explore new ways to support the development of capacity and expertise in conducting clinical trials. It is recognised that NIHR Advanced Fellowships award funding for salary, but that the scale of the awards cannot always support the research costs of a large clinical study.

This is the third pilot of a call in collaboration with the NIHR Academy, providing those wishing to pursue a NIHR Advanced Fellowship the opportunity to apply for a fellowship that will also support project funding to deliver and gain experience of leading a clinical study with appropriate mentorship.

This pilot has evolved from that run previously, to now involve a single application and review process, to facilitate the ease of submission and review. It is anticipated that the EME Programme may undertake similar calls with other post-doctoral schemes in the future.

Call specification

The NIHR Fellowships Programme and the MRC-NIHR EME Programme invite applications to the above call. Proposals are to be led by an Applicant who wishes to undertake a research study within the EME programme remit, as part of an NIHR Advanced Fellowship award.

A single application comprising both the elements of the NIHR Advanced Fellowship and the proposed EME-supported research project is required for submission. This will undergo a singular-joint review process involving both research and fellowship expertise.

Applications are welcomed across all areas of health and social care. The proposed study should aim to evaluate an intervention, test or technology with the potential to improve health and care outcomes, such as maintaining health, treating disease or improving recovery. It may use any robust study design that is considered most appropriate to achieve the study objectives.

This joint call is advertised in-line with a round of the NIHR Advanced Fellowship scheme; applicants to this specific call should apply only via this opportunity and should not submit the same application to either the Advanced Fellowship scheme or EME separately. The deadline for applications is 14 September 2023.

Applicants are strongly advised to attend webinars and the associated sessions run by the EME and Advanced Fellowship programme teams.

The review process for applications submitted to the MRC-NIHR EME – Advanced Fellowship Call: Building clinical trials experience will involve review by a joint EME-Advanced Fellowship committee who will make a funding recommendation for the entire application.

Eligibility

Applicants to this call must meet the eligibility criteria for both the EME Programme and the Advanced Fellowship scheme, and applicants are strongly advised to consult the call guidance notes.

To be eligible, lead applicants must hold a relevant PhD or MD, or have submitted their thesis for examination at the time of application and must have been awarded their PhD or MD by the time they attend interview. Lead applicants must not already hold a Chair at the point of application.

Applicants from institutions based in the Devolved Administrations should contact the EME secretariat before completing an application, to clarify eligibility and the application process.

Background

The EME Programme funds ambitious studies evaluating interventions that have the potential to make a step-change in the promotion of health, treatment of disease and improvement of rehabilitation or long-term care.

Applications are sought for research into the efficacy and mechanism of interventions that are based in or used by the National Health Service (NHS) and its partners. This includes:

  • Efficacy studies - these aim to evaluate the efficacy of a wide range of interventions, where there is some human ‘proof-of-concept’, i.e. a signal that the technology may work
  • Combined Efficacy and Mechanistic studies, which both evaluate an intervention and test hypotheses around its mechanism of action within the same study

Efficacy studies

The EME Programme supports translational research evaluating a wide range of novel or repurposed interventions and technologies. These may include but are not limited to diagnostic or prognostic tests and decision-making tools, drugs or biological compounds, behavioural therapies, medical devices, and public health initiatives delivered within the NHS.

EME primarily supports clinical trials, and other robustly designed studies that test the efficacy of interventions. The interventions should have the potential to improve patient care or benefit the public. The Programme will only support studies where there is sufficient evidence that the intervention might work in man, i.e. that there is 'proof of concept’. Where appropriate, the Programme encourages hypothesis-testing mechanistic studies integrated within the main efficacy study, but this is not a requirement.

Innovative study designs involving stratification, the use of routinely collected digital data or novel methodologies are strongly encouraged.

The Programme will accept applications for studies that use clinical or well-validated surrogate outcomes. It will also consider studies that validate potential surrogate outcomes against a primary clinical outcome, within the main clinical trial.

Applications may set out programmes of work which contain distinct stages. It is expected that the early stages of the study will, if successful, lead onto a full evaluative clinical study or trial, which is in the remit of the EME Programme. This study must also be included and clearly specified within the application. Clinical trials embedded within the programme of work must be large enough to detect a meaningful effect.

Applications to this call may also include initial stages such as:

  • the limited steps needed to progress the development of an intervention to a stage suitable for use in an accredited clinical service
  • prospective clinical work or retrospective research utilising existing big data or clinical samples to inform the main study
  • pilot or feasibility studies

As a rough guide, it is expected that these early stages will be complete within the first 18 months of the project and must not contribute more than 25% to the total cost or duration of the project.

Applicants will need to make a strong case for the future importance of the intervention through providing a measurable positive impact on health, innovation or future wealth creation and for the ultimate benefit of individual patients or the wider NHS. Applicants should read the details of the EME remit.

Mechanistic studies

Mechanistic studies may form part of an application to EME to conduct an efficacy study. Mechanistic proposals will be accepted across a wide range of interventions; this includes:

  • behavioural
  • pharmaceutical
  • psychological
  • surgical
  • public health

The research should be hypothesis-testing, relevant to the intervention and outcomes proposed by the original study and add significantly to the scientific understanding of the mechanisms of action of the intervention. Funding will not be available for hypothesis-generating studies.

These studies should explore the mechanisms of action of the intervention, the causes of differing responses, or promote an understanding of any potential adverse effects and how these could be reduced; they could also contribute to understanding of the disease. Discovery of new biomarkers is not within the remit of the EME Programme.

Applicants will need to make a strong case for how a better understanding of the mechanisms of action will potentially contribute to the future use or development of the intervention, future wealth creation and for the ultimate benefit of individual patients’ or the wider NHS.