IAPO is a partner in GetReal, a three-year collaborative European Project by the Innovative Medicines Initiative (IMI), which aims to explore getting real-world evidence into the drug development process.
GetReal explores how real world research data can be used in the development of drugs, to increase effectiveness and enrich decision-making by regulatory authorities and health technology assessment (HTA) agencies. IAPO's role is to bring the perspective of patients and patients' organizations to this work, and facilitate the input of member organizations into the study. As a partner in this project, IAPO hopes to contribute to improving medicine development process so patients have access to the drugs that they need.
IAPO is involved in two parts (work packages) of the project. The first work package is developing a shared platform to consider alternative study designs in medicine development. A shared platform will help to check that different options for study designs meet the needs of everyone involved in the different stages of the development process right through to appropriate use in the clinical setting, while increasing the efficency and/or reducing the cost of the research and development process.
The second work package that IAPO is involved with is looking at the potential use of study design alternatives to randomised control trials, and investigating whether and how they can be used before a medicine is launched. This work is exploring how methodology and study designs currently used after a medicine has been launched, may be able to be used before licensing.