Key important initiatives

There are a number of initiatives in addition to GetReal which are directly considering the use of real-world evidence (RWE) to provide information on relative effectiveness of interventions, or which are undertaking activities that are related to this aim, such as in adaptive pathways or adaptive licensing.

Table 1. Initiatives, programmes, units, or published strategies on real-world data.

EMA Adaptive pathways to patients An adaptive pathway pilot was run between March 2014 and August 2016 and is exploring the concept further in the context of parallel scientific advice with HTA bodies.
IMI ADAPT SMART An IMI project enabling a platform for coordinating Medicines Adaptive Pathways to Patients (MAPPs) activities which looks to ‘foster access to beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span in a sustainable fashion’.
IMI Big data for better outcomes (BD4BO) programme The Big Data for Better Outcomes programme aim is to act as a catalyst, supporting the evolution of European healthcare systems to becoming more outcomes-focused and sustainable by capitalising on the opportunities of using big and deep data sources to generate evidence to inform policy debates.

Information on disease-specific projects can be found here:

Core Outcome Measures in Effectiveness Trials (COMET) COMET works to develop and apply agreed standardised sets of outcomes that should be measured and reported in all clinical trials on a specific condition. They have developed a database of all studies relevant to the development of core outcome sets for use in clinical trials.
IMI Electronic Health Record systems for Clinical Research (EHR4CR) This was a 5 year project that completed in 2015 aiming to provide adaptable, reusable and scalable solutions (tools and services) for reusing data from electronic health record (EHR) systems for clinical research.
European Network of HTAs (EUnetHTA) – Joint action 3 (2016-2020) Joint Action 3 aims to implement a sustainable model for scientific and scientific cooperation on HTA in Europe. Work package 5 will consider the generation of evidence along the life cycle and develop tools that support collection and use of high quality data.
IMI European Medical Information Framework (EMIF) The EMIF was launched in January 2013 as a 5-year project which will develop a common technical and governance solutions and improve access and use of health data. ‘A common Information Framework (EMIF-Platform) will link up and facilitate access to diverse medical and research data sources.’
U.S. Food and Drug Administration (FDA) The FDA has a number of related initiatives:  Patient-Focused Drug Development Initiative, the Patient Representative Program, and the Patient Preferences Initiative.
International Society for Pharmacoeconomics and Outcomes Research (ISPOR) taskforce on real-world data This working group published a taskforce report in 2007 and are working to create an new and updated taskforce report.
NEW Drug Development ParadIGmS (NEWDIGS) A network of 31 institutions led by Massachusetts Institute of Technology (MIT) aimed at enhancing the capacity of the global biomedical innovation system to reliably and sustainably deliver new, better, affordable therapeutics to the right patients faster. NEWDIGS members recently co-authored a study setting out ways of enabling patients to access innovative medicines faster (Baird et al 2014). MIT also hosts other departments with an interest in Adaptive Licensing including the Center for Biomedical Innovation and the Department of Political Science and Engineering Systems Division with relevant studies being published across these. See also the Janus Initiative here.
Patient-Centered Outcomes Research Institute (PCORI) PCORI is a non-profit, nongovernmental organisation with a mandate to improve the quality and relevance of evidence available to support informed health decisions. PCORnet is a national patient-centred clinical research network ‘to make health research more efficient and powerful, and less expensive, by collaboratively harnessing the power of large amounts of health data’; this network includes both clinical research and patient-powered research networks.

In addition to the initiatives listed above, there are additional initiatives listed on individual pages within this site (for example, on specific RWD sources).