The final stages of the projects IDeAl, InSPiRe and asterix conclude with the joint workshop Seventh Framework Programme (FP7) small-population research methods projects and regulatory application hosted by the European Medicines Agency in London. During the workshop, the three projects will have the opportunity to intertwine their research in various in-depth workshops, unify their great thinkers, and reach beyond what has been accomplished so far. The hands-on discussions will provide international representatives of patient organisations, pharmaceutical industry, academic statisticians and clinical trial methodologists, clinical researchers, pharmaceutical industry and regulators with the latest recommendations for small population group trials. As a special highlight, the meeting will be broadcasted on the EMA website and, thus, reach stakeholders from all over the world.
Ralf-Dieter Hilgers is representing IDeAl, and disseminating the IDeAl results at the MMA-EURORDIS-COMP-IMI Conference in Malta this week. As an invited speaker, he seized the chance to present “Innovative statistical design methodologies for clinical trials in small populations focussing on rare diseases“. This conference, organized during the Maltese Presidency aims at discussing the development of medicinal products for rare diseases. It brings together the European Organisation for Rare Diseases (EURORDIS), EU Health Ministers, experts from the Committee of Orphan Medicinal Products (COMP) and the members of the Innovative Medicines Initiative (IMI), and provides an IDeAl forum for disseminating our results to the regulators of the day.
Three projects, Asterix, IDeAl and InSPiRe, have been funded by the EU within the Seventh Framework Programme to develop new methodology on design and analysis of small population clinical trials since 2013. A joint dissemination workshop will be held at the European Medicines Agency on 29 & 30 March 2017.
The aim of the workshop is to translate and promote novel methodologies of all three EU FP7 funded projects into tangible recommendations. This research should advance clinical research and the development of new treatments in small populations, such as in rare diseases, children or targeted therapies for personalized medicine. The results and recommendations for applications will be discussed with international representatives of patient organisations, academic statisticians, clinical trial methodologists, clinical researchers, pharmaceutical industry, HTAs and regulators.
Please note that the meeting shall be broadcasted online via the EMA webpage (tbc).
It would be great to welcome you at the meeting!
Under the slogan “With research, possibilities are limitless”, todays Rare Disease Day 2017 is focussusing on the theme research. As the Orphanet Journal of Rare Diseases states it, continual research is necessary in order to unlock the mysteries often presented by rare diseases. The IDeAl consortium is proud to support this process with the latest advances in statistical methodology. We are on an IDeAl way!
The IDeAl Annual Meeting from on the 7th and 8th of November 2016 was a great success. In addition to discussing administrative issues concerning the progress and the prolongation of the project, the reaserchers had plenty of time to discuss their ideas for the final phases of IDeAl with their external advisors from patient organizations, academia, and regulatory offices. The discussions will shape their research in the following months. An additional highlight was Stephen Senn’s dinner speech on the challenges of interdisciplinary collaboration.