The Innovative Medicines Initiative (IMI) has launched a new project called GETREAL that will investigate new ways to integrate data from real-life settings, such as clinics, into drug development in Europe. This will assist healthcare decision makers in choosing how best to grant patients access to a new treatment and help pharmaceutical companies make better decisions during drug development.

Once a new drug has been developed, it must be reviewed by both the marketing authorization and health technology assessment (HTA) bodies. For marketing authorization, regulators draw on data, mostly from clinical trials, to determine if a drug is safe and works well enough to be authorized for patient use. For their part, HTA organizations assess the drug’s “relative effectiveness,” which is the extent to which a treatment does more good than harm when compared to one or more alternative treatments when provided under normal healthcare circumstances.

Ideally, HTA organizations need data from real life settings, yet there is little guidance on how to generate real world data and integrate this into drug development before launch. This is a serious issue in drug development—even if a drug is approved as safe and efficacious by the regulators, insufficient evidence supporting relative effectiveness at the time of launch may delay, or restrict patient access to new treatments. The challenge, therefore, is to incorporate innovative study designs into the earlier stages of drug research and development, to ensure both regulators and HTA bodies get the data they need. This is where the GETREAL project comes in.

The project brings together for the first time all key stakeholders (industry, academia, regulatory agencies, health technology assessment bodies, healthcare budget holders and patient groups) to share their perspectives and insights on how effectiveness/relative effectiveness can best be assessed in HTA decision-making processes, and so will pave the way for advancing the development of new approaches for incorporating real life data into drug development.

Michel Goldman, IMI executive director, said, “Collaboration between these diverse groups can be sensitive. By bringing them together in the safe harbor offered by IMI, GETREAL is in a unique position to reach a greater consensus on these issues to improve the efficiency of R&D and the decision-making processes.”

Working together, these diverse partners will analyze existing processes and methodologies for HTA. GETREAL also will generate a decision-making framework to help pharmaceutical companies design drug development strategies. A significant part of the project is devoted to organizing training activities for researchers, healthcare decision makers and other stakeholders on relative effectiveness concepts and how they can be applied.