On the 9th of September, the Chair of the EFA COPD Working Group, Michael Wilken, represented COPD patients’ views on the IMI GetReal COPD case study workshop held in Frankfurt, Germany.
Launched in October 2013, GetReal is a three-year project of the Innovative Medicines Initiative (IMI). IMI is an EU public-private consortium exploring 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. The foreseen benefits of this are manifold – not only will it help pharmaceutical companies take better decisions during drug development, it will aid healthcare decision makers when deciding how best to grant patients access to a new treatment.
EFA was invited by the International Alliance of Patient Organisations (IAPO) to highlight the COPD patients’ perspective. The work stream, of which the COPD workshop is a part, 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, and whether/how these can be accepted by difference stakeholders.
To find out more about IMI GetReal please visit the project website.