The European Union’s Innovative Medicines Initiative (IMI) has officially launched its multi-stakeholder, €16.3 million GETREAL project, which is looking at new ways to integrate data from real-life settings into drug development.

The project brings together all of the key stakeholders in drug development and access industry, academia, regulatory agencies, health-technology assessment (HTA) bodies, healthcare budget-holders and patient groups to share perspectives and insights on how effectiveness and relative effectiveness might best be assessed in the HTA decision-making process.

This should pave the way for incorporating innovative study designs into the earlier stages of drug research and development, so that both regulators and HTA bodies “get the data they need”, IMI says.

Relative effectiveness

As it points out, HTA organisations assess a drug’s ‘relative effectiveness’, which IMI defines as “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, these organisations need data from real life-settings to inform their assessments. Yet there is little guidance on how to generate real-world data and integrate the data into drug development before launch, IMI notes.

This is a serious issue, as insufficient evidence to support relative effectiveness may delay or restrict patient access to new treatments, it adds.

Integrating data from real-life settings, such as clinical practice, into drug development will help both healthcare decision-makers in determining how best to grant patients access to new treatments, and pharmaceutical companies in making better choices during drug development, IMI explains.

Safe harbour

Collaboration between the diverse groups with a stake in drug development and access “can be sensitive”, acknowledged IMI executive director Michel Goldman.

By bringing these groups together in “the safe harbour offered by IMI”, he said, 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”.

The GETREAL stakeholders will work together to analyse existing HTA processes and methodologies, as well as generating a decision-making framework to help pharmaceutical companies formulate drug-development strategies.

A significant part of the project will be organising training activities for researchers, healthcare decision-makers and other stakeholders on relative-effectiveness concepts and how they can be applied.

Funding split

The GETREAL project is supported by funding of €8 million from the IMI, €6 million in kind from member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA), and €2.3 million from other sources.

The project coordinator is Chris Chinn, vice-president and head of Health Investment Evidence, European Access to Medicines, at GlaxoSmithKline.