Within GetReal, early stakeholder engagement was identified as a key success factor in relation to designing pragmatic trials or other study designs for the generation of Real World Evidence early in the drug development.
Currently no guidance exists to assist study teams on who to approach for what question and at what time point. This document is based on experience from the Salford Lung Study and from the different stakeholders within GetReal. It aims to give an overview who the most relevant stakeholders are, when to possibly engage with them and what questions need to be answered.
Please note that this list can only be generic as stakeholder involvement is strongly depended on the respective study and country. Therefore, this list does not claim to be complete or applicable for all trials but it can give an initial overview to develop a study specific stakeholder engagement plan.