GetReal: launch of EU-funded project to get real life data into drug development
Once a new drug has been developed, it must be reviewed by both the regulators and health technology assessment (HTA) bodies. The regulators draw on data, mostly from clinical trials, to determine if a drug is safe and works well enough to be authorised for use in patients. For their part, 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.
To do this, HTA organisations need data from real life settings, yet there is little guidance on how to generate real world data and integrate the data into drug development before launch. The challenge is to incorporate alternative data sources and study designs into the earlier stages of drug research and development.
A group of ISPM researchers (Matthias Egger, Sven Trelle, Sandro Gsteiger, Klea Panayidou and others) will lead one of four GetReal packages. The theme of this work package is the estimation of relative effectiveness of drug interventions in chronic diseases based on different sources of evidence and methods, and the generalizability and applicability of relative effectiveness estimates to different patient populations. The investigators will use network meta-analysis and mathematical modelling and apply them to concrete case studies in oncology, cardiology and neurology. ISPM will work with researchers based at the University of Ioannina, Utrecht, Groningen and Leicester, and with pharmaceutical companies. The GetReal consortium is led by Diederick Grobbee (Utrecht) and Chris Chinn (GlaxoSmithKline).
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