Rationale
The MRC-NIHR Efficacy and Mechanism Evaluation (EME) Programme is inviting applications for large, collaborative and ambitious precision medicine platform studies. The study must aim to efficiently evaluate the efficacy of multiple targeted interventions, in a defined condition or area.
Applications with international collaboration will be particularly welcome where this will benefit the study, for example by enabling recruitment in rare disease or phenotypes.
In 2022, the EME Programme launched an Application Acceleration funding opportunity to support the development of applications in this area. The applications developed through these awards should be submitted to this call. This call is also open to applications for other platform studies, for which development work has been completed and the team is ready to apply with a Stage 1 application for the full study.
Through this call, the Programme hopes to fund multiple platforms. Collectively, these projects should also aim to enhance learning around the potential efficiencies, challenges and conduct of platform designs.
Call scope
Applications to this call must describe a precision medicine platform study seeking to evaluate a number of predetermined technologies. Each technology must have sufficient clinical, human proof of concept, such that the proposed trial arms are each within remit for the EME Programme.
Although the platform must set out to evaluate predetermined interventions, applicants should describe an adaptive protocol, able to discontinue study arms as appropriate and incorporate additional interventions as candidates are identified. For adaptive designs, a clear process and Independent Scientific Advisory Group for the identification and prioritisation of candidate interventions should be described.
The proposed study must be multi-centre and collaborative; bids involving a single institution are not likely to be considered competitive.
Applications with international collaboration are particularly welcome where this will benefit the study, for example by enabling recruitment in rare disease or phenotypes. Applicants including an international element should note the following:
- the application must be multi-centre and UK-led.
- the EME Programme is typically not able to provide funding for international recruitment. Applicants will be required to demonstrate that consideration has been given to the funding of any recruitment outside of the UK, where appropriate.
- the benefit of international recruitment will require justification, including whether this is in a similar health and healthcare context, generalisable to the UK.
- for more information, please read our International Funding guidance.
Additionally, consideration must be given to a strategy that allows collaborators to join and exit the platform as appropriate and a publications plan that enables recognition of collaborators’ contribution.
Consideration should be given to experience and capacity building amongst early career researchers.
Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity.
Duration and costs
The EME Programme is keen to receive ambitious applications to this call. We note that due to the size and complexity of platform trials, proposed projects are likely to be more costly than typical EME awards. There is no set upper limit for the duration or cost of applications, however value for money will be a key consideration
Applications must detail project costs and duration according to the initial interventions proposed. However, as applications for adaptive studies are welcomed under this call, it is anticipated that commissioning may comprise two stages:
- part 1 – MRC-NIHR EME Programme call to commission the infrastructure of a platform trial, including initial interventions.
- part 2 – Additional funding to support per-intervention costing, to continue to populate the platform. Requests for additional funding to incorporate additional interventions will be considered by the MRC-NIHR EME Programme and DHSC. Amended payment schedules will then be agreed for any further funding.
Applicants are encouraged to consider the sustainability of the platform beyond the initially funded work, where relevant.
Process for assessment of applications
Applications to this call will follow a two-stage application process. The deadline for Stage 1 applications will be 4 May 2023. The deadline for shortlisted Stage 2 applications will be 7 September 2023.