Evidence Synthesis via Indirect Treatment Comparisons in the European Framework of Joint Clinical Assessment

The application of the Health Technology Assessment Regulation (HTAR) gives way to joint European work, such as the Joint Clinical Assessment (JCA). This requires the definition of a PICO (Population-Intervention-Comparator-Outcome) question representative of all the member states of the European Union. The key to answering the PICO will be the synthesis of evidence through direct comparisons when there are randomized clinical trials (RCTs) including the same comparators, and via indirect treatment comparisons (ITCs) when comparators differ across RCTs. The aim of this report is to provide a synthesized and clear methodological framework to guide those stakeholders involved in JCAs when interpreting the results of ITCs, including descriptions on: (1) assumptions associated with ITCs; (2) how to select the method for ITC; (3) strengths and limitations associated with the methods; and (4) basics for understanding the method for ITC. This methodological framework could help those health care institutions, patient associations, consumer organizations, health-related nongovernmental organizations, health technology developers, and healthcare professionals involved in JCAs to better understand ITCs and incorporate this evidence into decision-making.