New IMI Project to Incorporate Real Life Data into Drug Development

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

Once a new drug has been developed, it must be reviewed by both the marketing authorisation and health technology assessment (HTA) bodies. HTA organisations 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 organisations 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 - insufficient evidence supporting relative effectiveness 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.

IMI Executive Director Michel Goldman said: "Collaboration between these diverse groups can be sensitive. By bringing them together in the safe harbour 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 analyse existing processes and methodologies for HTA. GETREAL will also generate a decision-making framework to help pharmaceutical companies design drug development strategies. A significant part of the project is devoted to organising training activities for researchers, healthcare decision makers and other stakeholders on relative effectiveness concepts and how they can be applied.

About IMI
The Innovative Medicines Initiative (IMI) is the world's largest public-private partnership in health. IMI is improving the environment for pharmaceutical innovation in Europe by engaging and supporting networks of industrial and academic experts in collaborative research projects. The European Union contributes €1 billion to the IMI research programme, and this is matched by in kind contributions worth at least another €1 billion from the member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA).

The Innovative Medicines Initiative currently supports 46 projects, many of which are already producing impressive results. The projects are all working to address the biggest challenges in drug development, with the goal of accelerating the development of safer and more effective treatments for patients.

Most Popular Now

Philips Foundation 2024 Annual Report: E…

Marking its tenth anniversary, Philips Foundation released its 2024 Annual Report, highlighting a year in which the Philips Foundation helped provide access to quality healthcare for 46.5 million people around...

Giving Doctors an AI-Powered Head Start …

Detection of melanoma and a range of other skin diseases will be faster and more accurate with a new artificial intelligence (AI) powered tool that analyses multiple imaging types simultaneously...

Scientists Argue for More FDA Oversight …

An agile, transparent, and ethics-driven oversight system is needed for the U.S. Food and Drug Administration (FDA) to balance innovation with patient safety when it comes to artificial intelligence-driven medical...

AI Agents for Oncology

Clinical decision-making in oncology is challenging and requires the analysis of various data types - from medical imaging and genetic information to patient records and treatment guidelines. To effectively support...

Start-ups in the Spotlight at MEDICA 202…

17 - 20 November 2025, Düsseldorf, Germany. MEDICA, the leading international trade fair and platform for healthcare innovations, will once again confirm its position as the world's number one hotspot for...

Using Data and AI to Create Better Healt…

Academic medical centers could transform patient care by adopting principles from learning health systems principles, according to researchers from Weill Cornell Medicine and the University of California, San Diego. In...

AI Medical Receptionist Modernizing Doct…

A virtual medical receptionist named "Cassie," developed through research at Texas A&M University, is transforming the way patients interact with health care providers. Cassie is a digital-human assistant created by Humanate...

AI Detects Hidden Heart Disease Using Ex…

Mass General Brigham researchers have developed a new AI tool in collaboration with the United States Department of Veterans Affairs (VA) to probe through previously collected CT scans and identify...

AI Tool Set to Transform Characterisatio…

A multinational team of researchers, co-led by the Garvan Institute of Medical Research, has developed and tested a new AI tool to better characterise the diversity of individual cells within...

Human-AI Collectives Make the Most Accur…

Diagnostic errors are among the most serious problems in everyday medical practice. AI systems - especially large language models (LLMs) like ChatGPT-4, Gemini, or Claude 3 - offer new ways...

MHP-Net: A Revolutionary AI Model for Ac…

Liver cancer is the sixth most common cancer globally and a leading cause of cancer-related deaths. Accurate segmentation of liver tumors is a crucial step for the management of the...

Northern Ireland Completes Nationwide Ro…

Go-lives at Western and Southern health and social care trusts mean every pathology service is using the same laboratory information management system; improving efficiency and quality. An ambitious technology project to...