GetReal was presented at the Statisticians in the Pharmaceutical Industry (PSI) 2014 annual conference in London, UK (11-14 May) in a session dedicated to IMI. The session began with Graham Somers (GSK) describing the aims and objectives of IMI, explaining some of the IMI projects and providing an insight of the strategic agenda that will form IMI2. Deborah Ashby (Imperial College London) presented the PROTECT project where she underlined the recommendations and best practices for benefit-risk assessments, including illustrating the various methodologies that have been reviewed and presenting the website containing many useful sources of information. Chrissie Fletcher (Amgen) introduced the GetReal project where she presented the aims and objectives of GetReal and walked through the activities each working party are undertaking. As the audience were statisticians who work in the pharmaceutical industry, it was emphasized what the importance of the GetReal project is to the statistical community, which in the future will influence:
- Health Technology Assessment (HTA) strategy;
- The evidence generation program required to meet the needs of regulators and HTA decision makers;
- How effectiveness studies will be designed and conducted and
- How evidence will be synthesised and modelled to predict relative effectiveness assessments using all available data sources.
Furthermore, Dr. Fletcher emphasized statisticians will play a key role in the area of relative effectiveness, working closely with their clinical, regulatory and HTA specialists to provide the analytical insights to drug development programs and ensure the needs of regulators and HTA decision makers are being appropriately considered.