Innovative Trial Designs Conference

This session will highlight innovations in clinical trial design where information is borrowed or shared in the primary trial analyses. Examples will include sharing of information from within a trial, e.g. Basket Trials, or borrowing of information external to the trial. The use of information borrowing in trial design requires thoughtful consideration not only regarding which information that is shared or borrowed and the amount of borrowing, but also the statistical adjustments that need to be considered to ensure trial results are scientifically valid and accepted by the scientific community and regulatory authorities. Case studies with information borrowing or sharing, both internal and external to a trial, will be presented.