Trial Design and Delivery

The over-arching strategy of the Trial Design and Delivery theme, led by Professor Philip Newsome, is to focus on early phase clinical trials across the NIHR Biomedical Research Centre with a focus on biological inflammatory pathways. Close working with the research themes will allow for identification and prioritisation of relevant biological pathways in patients with inflammatory conditions. Consistent with this we will prioritise adoption of biological response markers into clinical trial design providing important mechanistic insights into the pathogenesis of inflammatory conditions. This will position us to offer pathway-specific as well as disease-specific early phase trials of anti-inflammatory cellular and re-purposed pharmacological therapies across our areas of clinical interest, offering added value to investigators and SMEs.

SHORT-TERM AIMS:

  • Develop protocols for evaluating immune pathway perturbations in chronic inflammatory diseases as monitor effect of therapies
  • To establish clinical grade protocols for the manufacture of mesenchymal stromal cells and establish new cell therapy programmes in inflammatory bowel disease and arthritis
  • Refine methodology for delivering trials of faecal microbiome transplantation building on the established programme in Birmingham
  • Share best practice and standard operating procedures for study design and data safety collection across the BRC for early phase experimental medicine studies

MEDIUM-TERM AIMS:

  • Start proof of concept clinical trials targeting novel immune pathways across the BRC
  • Complete cell therapy trials in inflammatory bowel disease and arthritis
  • Adopt the principles of the Trials Acceleration Programme across the BRC to expedite all aspects of trial set-up and recruitment.

LONG-TERM AIMS:

  • Establish a new taxonomy alongside new effective protocols for immune pathway manipulation in chronic inflammatory diseases
  • Coordinate multicentre cell therapy trials using mesenchymal stromal cells
  • Train a cadre of outstanding translational scientists, clinicians & nurses to deliver early phase trials in inflammation.

FURTHER INFORMATION