Incorporating real-life clinical data into drug development

the GetReal consortium

The GetReal consortium aims to improve the efficiency of the medicine development process by better incorporating real-life clinical data into drug development and to enrich decision-making by regulatory authorities and HTA bodies. The overall objective of GetReal is to better understand how real-world data and analytical techniques can be used to improve the relevance of knowledge generated during development, e.g., through innovation in clinical trial design. This can contribute to the knowledge base, particularly to inform clinical decision making and improve the efficiency of the R&D process.

GetReal is a public-private partnership between key European stakeholders and leading research groups. Participants have been working on real life clinical data and related topics both individually as well as jointly in various settings for several years. The consortium also includes members familiar with the processes and realities of commercial drug development, and the changes to R&D models that are under discussion. Several European organizations who are GetReal participants will ensure complete European coverage and EU-wide dissemination and implementation. These include the EMA, the Dutch reimbursement body CVZ that is a member of the EUnetHTA network in which the various reimbursement bodies throughout Europe are bundling their expertise on Health Technology Assessment, and the International Alliance of Patients' Organizations (IAPO) that covers patient organizations all over the world GetReal creates impact by developing a set of tools, decision frameworks, methods and insights to include real clinical data in drug development: GetReal will deliver within the timeframe of three years an important set of tools, decision frameworks, methods and insights that are of immediate use to public and private stakeholders and which can be applied in decision making and strategy development.

 

Publications

Makady A, Stegenga H, Ciaglia A, Debray TPA, Lees M, Happich M, Ryll B, Abrams K, Thwaites R, Jonsson P, Goettsch W on behalf of GetReal Work Packages 1 & 4. Practical Implications of Using Real-World Evidence in Comparative Effectiveness Research: Learnings from IMI-GetReal. J Comp Eff Res 2017:6;485-490.

Efthimiou O, Mavridis D, Debray TP, Samara M, Belger M, Siontis GC, Leucht S, Salanti G, on behalf of GetReal Work Package 4. Combining randomized and non-randomized evidence in network meta-analysis. Stat Med 2017:36;1210-1226.

Panayidou K, Gsteiger S, Egger M, Kilcher G, Carreras M, Efthimiou O, Debray TP, Trelle S, Hummel N, on behalf of the GetReal methods review group. GetReal in mathematical modelling: a review of studies predicting drug effectiveness in the real world. Res Synth Methods 2016:7;264-77.

Debray TP, Schuit E, Efthimiou O, Reitsma JB, Ioannidis JP, Salanti G, Moons KG, on behalf of GetReal Workpackage 4. An overview of methods for network meta-analysis using individual participant data: when do benefits arise?. Stat Methods Med Res 2018:7;1351-64.

Efthimiou O, Debray TP, van Valkenhoef G, Trelle S, Panayidou K, Moons KG, Reitsma JB, Shang A, Salanti G, on behalf of the GetReal methods review group. GetReal in network meta-analysis: a review of the methodology. Res Synth Methods 2016:7;236-63.

Debray TP, Moons KG, van Valkenhoef G, Efthimiou O, Hummel N, Groenwold RH, Reitsma JB, on behalf of the GetReal methods review group. Get real in individual participant data (IPD) meta-analysis: a review of the methodology. Res Synth Methods 2015:6;293-309.

Makady A, Stegenga H, Ciaglia A, Debray T, Lees M, Ryll B, Abrams K, Thwaites R, Garner S, Jonsson P, Goettsch W. Practicalities Of Using Real-World Evidence (RWE) In Comparative Effectiveness Research (CER). Value in Health 2017:9;A692.

Hummel N, Debray TPA, Didden E-M, Efthimiou O, Egger M, Fletcher C, Moons KG, Reitsma JB, Ruffieux Y, Salanti G, van Valkenhoef G, on behalf of WP4. Methodological guidance, recommendations and illustrative case studies for (network) meta-analysis and modelling to predict real-world effectiveness using individual participant and/or aggregate data. 2017:0.

Innovative Medicines Initiative

Source of Funding

The Innovative Medicines Initiative (IMI) is Europe's largest public-private partnership aiming to improve the drug development process by supporting a more efficient discovery and development of better and safer medicines for patients.

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