Real-life data in drug development
The Innovative Medicines Initiative (IMI) is a public–private partnership between the EU and the pharmaceutical industry that aims to speed up the development of better and safer medicines for patients. Launched in 2008, IMI is the largest life sciences partnership of its kind. It has a budget of over €3 billion for 2014–24, approximately half of which is provided by the pharmaceutical industry. IMI supports over 50 projects, some focused on specific conditions and others, such as GetReal, on broader challenges in drug development.
GetReal is a consortium bringing together pharmaceutical manufacturers, academic groups, research agencies, a patients’ organisation (IAPO), small and medium-sized enterprises (SMEs), and regulatory and health technology assessment agencies.
GetReal aims to show how robust new methods of real-world evidence (RWE) collection and synthesis could be adopted earlier in pharmaceutical research and development (R&D) and the healthcare decision-making process. The consortium is:
- bringing together healthcare decision makers, academics, pharmaceutical companies, clinicians and other societal stakeholders
- assessing existing processes, methodologies and key research issues
- proposing innovative trial designs and assessing the value of information
- proposing and testing innovative analytical and predictive modelling approaches
- assessing operational challenges, and proposing and testing the impact of solutions
- creating new tools to support decision-making, and to use in evaluating development programmes and assessing the value of new medicines
- sharing and discussing project outputs with healthcare decision makers, academics, pharmaceutical companies, clinicians and other societal stakeholders
- developing training for researchers, healthcare decision makers and societal stakeholders in the public and private sector to increase knowledge about effectiveness.
GetReal is organised into four main work packages (see image below). Work packages 2-4 (WP2, WP3, WP4) focus on understanding and testing aspects of the use or generation of RWE to support medicine development. Work package 1 (WP1) focuses on the views of stakeholders about the methods and study designs reviewed in GetReal. Decision-making stakeholders are regulatory authorities (marketing authorisation), health technology assessment agencies (reimbursement) and pharmaceutical company R&D (funding of trials and evidence generation). Other stakeholders include patient organisations and clinicians, whose insights inform the decision makers’ perspectives.
Image. Organisation of GetReal Work packages