Professor Peter McCulloch, Past Chair of the IDEAL Collaboration, explains the need for the IDEAL Framework.
The IDEAL Collaboration has produced recommendations for study design and reporting in order to improve evidence on surgical and interventional therapy innovation. It has endorsed a number of suggestions for specific study designs and reporting standards which are recommended at different stages in the Framework. These suggestions are underpinned by a series of general principles for design and reporting, which are based on the different questions to be addressed and the challenges faced at each stage in the process.
Deals with the evaluation of a medical device prior to first-in-human Stage 1 studies
Deals with proof of concept, involving first use in humans.
Evaluation records the iterative improvement of the intervention until it reaches a stable form. What was changed, when, why and with what impact on outcomes?
A common understanding of the procedure is reached among operators in a multi-centre study, and the obstacles to a definitive comparative trial are addressed.
Typically a randomized controlled trial (RCT).
Surveillance to identify rare and late outcomes as well as a possible broadening of ‘accepted’ indications.
