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Efficacy and Mechanism Evaluation
Specifically, the MRC-NIHR Efficacy and Mechanism Evaluation (EME) Programme wishes to fund a project which will accelerate the necessary learning and preparation to explore the feasibility of a phase 2 platform, and to establish the optimum approach for phase 2 platform architecture that tests multiple repurposed pharmaceutical interventions and/or non-pharmacological interventions and devices. The phase 2 platform will be UK-led and will aim to test multiple different therapies simultaneously and efficiently.
In preparation, the NIHR Innovation Observatory (NIHRIO) has undertaken a rapid horizon scan to identify repurposed medicines in clinical development for the treatment of ME/CFS, as well as related conditions such as long COVID and fibromyalgia. The horizon scan focused on medicines with a UK licence that are in phase 2 or 3 clinical trials, with trial registration dates from 2020 onwards.
The NIHRIO report is available to read.
We recognise that developing an application for a phase 2 platform represents a complex bid, which will require time and the navigation of specific challenges. The programme is therefore inviting applications for work which will accelerate the necessary learning and preparation to explore the feasibility of a repurposing platform. This will take the form of an Application Development Award (ADA). It is anticipated that teams may require up to £200,000 of ADA funding over a maximum of 18 months.
The ADA must deliver the following key outputs to determine the feasibility of establishing a platform, specifically:
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Efficacy and Mechanism Evaluation
Post-acute infection syndromes, including long COVID and myalgic encephalomyelitis/chronic fatigue syndrome
Research specification
We are keen to accelerate progress in the treatment and management of post-acute infection syndromes and associated conditions, including long COVID and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). This funding opportunity is a key component of the NIHR’s recognition of the need for further research-based evidence related to the diagnosis, management and treatment of post-acute infections and associated conditions.Specifically, the MRC-NIHR Efficacy and Mechanism Evaluation (EME) Programme wishes to fund a project which will accelerate the necessary learning and preparation to explore the feasibility of a phase 2 platform, and to establish the optimum approach for phase 2 platform architecture that tests multiple repurposed pharmaceutical interventions and/or non-pharmacological interventions and devices. The phase 2 platform will be UK-led and will aim to test multiple different therapies simultaneously and efficiently.
In preparation, the NIHR Innovation Observatory (NIHRIO) has undertaken a rapid horizon scan to identify repurposed medicines in clinical development for the treatment of ME/CFS, as well as related conditions such as long COVID and fibromyalgia. The horizon scan focused on medicines with a UK licence that are in phase 2 or 3 clinical trials, with trial registration dates from 2020 onwards.
The NIHRIO report is available to read.
We recognise that developing an application for a phase 2 platform represents a complex bid, which will require time and the navigation of specific challenges. The programme is therefore inviting applications for work which will accelerate the necessary learning and preparation to explore the feasibility of a repurposing platform. This will take the form of an Application Development Award (ADA). It is anticipated that teams may require up to £200,000 of ADA funding over a maximum of 18 months.
The ADA must deliver the following key outputs to determine the feasibility of establishing a platform, specifically:
- development of robust and reproducible methods for the prioritisation of compounds and identification of a minimum of 2 interventions for inclusion in the first phase of a future phase 2 platform trial
- identification and agreement of core clinically relevant outcome measures that reflect meaningful changes in quality of life/clinical outcomes in post-acute infection syndromes and associated conditions
- define and justify inclusion criteria and methodology to improve stratification for any future trials, specifically opportunities for inclusion of pre-consented participants from cohorts such as Decode-ME
- development of an efficient trial design for the proposed repurposing platform
- consideration of ways to ensure the sustainability and longevity of any future platform infrastructure
- understanding MHRA evidence requirements to support licence variations for therapies focused on symptom control
- a written summary of the project
Funding opportunity scope
Applications to this funding opportunity must aim to accelerate the development of an application for a phase 2 platform study to evaluate repurposed pharmaceutical interventions and/or non-pharmaceutical interventions including digital/devices, for the management and treatment of post-acute infections and associated conditions. This platform must be positioned as a phase 2 study, within the remit of the MRC-NIHR EME Programme. Importantly, applicants should note that for inclusion within the platform, interventions must demonstrate strong proof of concept in humans with post-acute infection syndromes and associated conditions, such that a clinical benefit might reasonably be expected in a trial.continued at link.
