Early phase study design

Led by: Professor Jane Blazeby, Dr Sian Cousins, Dr Natalie Blencowe

The IDEAL framework was developed for evaluation of surgical innovation from first-in-human to Phase IV studies. However, IDEAL has not been widely adopted and surgical innovation continues without transparent and structured evaluation or oversight. Based on our new work in this field, and our surgical and methodological expertise and leadership we will:

  • Establish practical and transparent definitions for stages of innovative surgical interventions.
  • Develop methods that can be used to classify the stage of innovation of novel surgical interventions and establish whether and when an intervention is ready for safe transition between these stages.
  • Test and refine the methods for classifying stages of surgical innovation in case studies, in partnership with NHS and academic surgeon innovators;

Work with key stakeholders, including through conferences and stakeholder workshops, to disseminate and ensure adoption of the finalised methods by studies evaluating surgical innovation.