Formulations Workstream
Inappropriate formulations can cause significant delays and complications in clinical trials and lead to poor reliability and validity of the outcomes. Scrutiny of formulation related issues, ideally at protocol development and feasibility assessment stages, is essential in achieving efficient trial set-up. MCRN recognised that formulations and appropriate trials supplies and presentation (active drug and matching placebo) are critical to the authorisation and success of studies and has appointed 3 full-time formulation research fellows, closely affiliated to different LRNs and CSGs, including the latter devoted to Pharmacy & Pharmacology.
How can the Formulation Research Fellows assist investigators?
They scrutinise the protocols very early on to identify potential pharmaceutical and formulation challenges in clinical trial design, ranging from:
- Dosing accuracy
- Safety of excipients
- Administration volumes, accuracy and reproducibility
- Appropriateness of formulation for the age range
- Shelf life and in-use stability, Storage requirements
- Compatibility with food/vehicles
- Estimates of timelines & costs
- Sourcing of IMPs (active/placebo) and trial packaging
- Licensing requirements surrounding product preparation or compounding
They also advise on investigations to be performed if appropriate; in some instances, they have the capacity to carry out such experiments, if funding is available.
Led by Professor Tony Nunn, the MCRN formulation workstream encompasses broader strategic activities such as the identification of research priorities, the development of a viable, cost-effective research agenda and rational programmes that envelop all aspects of formulation issues associated with children’s medicines.