Protocol Development

The Protocol for a Clinical Study describes the background, rationale, objectives, design, methodology, statistical considerations and organization of a clinical research study. The Clinical Study Protocol ensures safety of trial participants and the integrity of the clinical data. 

The Trials Accelerator can assist with Protocol Development through consultation to understand the product or intervention under investigation, by providing templates and connecting academic and commercial partners with subject matter experts and appropriate bodies where relevant.  

The Trial Design Advisory Service can help refine the research question, funnelling novel research questions that address unmet clinical needs. Incorporating innovative methodology to improve the planning, implementation and reporting of studies. Choosing appropriate outcomes and controls for the population, assisting with sample size calculations to ensure the study is appropriately powered, and minimising bias through allocation concealment where possible and randomisation where appropriate.