GREG

Real-world data and evidence (RWD/RWE) have immense potential to contribute to the development and evaluation of medicines, medical devices, and drug-device combinations. Guidance on how this could work exists, but is high level, not evidence-based, and implementing it in practice is far from easy.

The aim of GREG is to turn this situation around by generating guidance and tools to advance the use of RWE in the development and evaluation of medicines, medical devices and drug-device combinations, and to support regulatory and health technology assessment (HTA) decision-making.

The consortium comprises leaders from key European RWE initiatives including academics, regulators, HTA agencies, and industry leaders from the medicines, medical device and drug-device sectors.

The team will start by compiling libraries of use cases where RWE was used, successfully or unsuccessfully, in different settings (e.g. regulatory decision-making, HTA…) at different stages of the development life cycle. They will also gather information on what different stakeholders need when it comes to RWE.

All of this will feed into studies that will generate the evidence needed to draft guidance and recommendations, to be co-created with stakeholders and subsequently tested in additional pilot studies.

This process will allow the project to deliver much-needed resources on the use of RWE, including evidence-based guidance documents and tools; training on their use; and structured templates for regulatory and HTA submissions. Ultimately, these will help those developing medicines, devices and drug-device combinations to prepare more robust and consistent RWE evidence to regulators and HTA agencies. In turn, the GREG outputs will also allow regulators and HTA bodies to assess these submissions more easily and consistently.

Once implemented, the GREG project’s results should therefore help to speed up the development and evaluation of medicines, devices and drug-device combinations, and patients’ access to them.