26
Accepted
Mandate DHSC, NIHR and MHRA to support phage researchers' clinical trial applications
Recommendation
The funding of clinical trials, especially later trials, has proved an obstacle for phages. We were pleased to hear that the National Institute for Health and Care Research would welcome applications from phage researchers and companies to access public funding to conduct clinical trials. We recommend that DHSC and the National Institute for Health and Care Research follow up on this amenability to receive applications from phage researchers for clinical trials by engaging with them and supporting them in their applications. Similarly, we recommend that the Medicines and Healthcare Products Regulatory Agency offers tailored support for phage applications for clinical trials.
Government Response Summary
The government states that the NIHR offers an existing Research Support Service for researchers, including those working on phages, and that MHRA's upcoming guidance will recommend sponsors engage with them for scientific advice, which MHRA already provides.
Paragraph Reference
110
Government Response
Accepted
Government Response
Accepted
HM Government
Accepted
In addition to the above commitment to engage with the UK KTN Phage Innovation Network and other stakeholders on phage research, the NIHR offers an NIHR Research Support Service for phage researchers. This provides free and confidential advice to develop funding applications within the remit of the NIHR, including clinical, applied health and social care research, and post-award advice to award holders. Access to support, advice and expertise is available for all researchers across England applying to NIHR research programmes or research training awards as well as to non-NIHR funders such as charities. When considering applications to NIHR for funding, researchers should review the 'remit pages'. The most suitable programme for phage research would depend on the research area, the scale of the study, and whether it will generate new evidence or build upon existing evidence. There is scope for significant further 'basic' phage research, which would be best supported by the UKRI councils. For clinical trials specifically, there are 2 large NIHR programmes offering funding: the Efficacy and Mechanism Evaluation (EME programme) and the Health Technology Assessment (HTA) programme. The EME programme funds studies into the efficacy of new approaches to disease prevention and treatment. It supports clinical trials and other studies that test how interventions may work in practice. This programme is co-funded with the MRC and is predominantly focused on evidence generation for areas where there is sufficient proof of concept data. A specialist team is available for specific queries about the process from researchers. The HTA programme funds research into the clinical- and cost-effectiveness of treatments and tests. HTA research compares new technology to the current standard interventions to see which works best, where there is already evidence to show a new technology is effective. Health technology covers any method used to promote health, prevent and treat disease and improve rehabilitation or long-term care. 'Technologies' in this context are not confined to new drugs or equipment, but include procedures, devices, tests, settings of care, screening programmes and any intervention used in the treatment, prevention or diagnosis of disease. They should be currently used in the NHS, or likely to be used if supported by the results of the research. Technologies being evaluated should have had some assessment of efficacy already. Researchers can receive support in advance of their application. The MHRA's draft guidance on the licensing requirements for phage therapeutic products will recommend that sponsors engage with MHRA at the earliest opportunity to obtain clarity regarding requirements for clinical trials, including Good Clinical Practice requirements. The MHRA will provide scientific advice but cannot design clinical trials on behalf of product developers. The VMD encourage all stakeholders looking to develop phage based VMPs and wishing to conduct UK clinical trials to contact the VMD for support and advice. The UK framework for veterinary clinical trials is currently fit for purpose and would allow the authorisation of trials involving phage based VMPs.
Source
Report
First Report - The antimicrobial potential of bacteriophages
03 Jan 2024
HC 328
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age
2.4 yrs
Report published
03 Jan 2024