Using similar endpoints in clinical RSV studies (both clinical trials and observational studies) is crucial for the comparability of the efficacy or effectiveness of different products. Furthermore, the use of standardized endpoints helps determine the comparative cost-effectiveness of interventions in the society. We have reviewed endpoints used in previous clinical studies in the field of RSV and influenza and the strengths and limitations of each endpoint. This document is intended as a starting point for discussions between public health and private stakeholders and will feed into later PROMISE outputs, including study protocols. Future work (backed by a full systematic review of endpoints used in literature and stakeholder consultation) could classify endpoints further e.g., based on specificity and clinical relevance as well as pragmaticism and cost-efficiency of studying them.
The Innovative Medicines Initiative is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). It is working to improve health by speeding up the development of the next generation of medicines, particularly in areas where there is an unmet medical or social need. It works by facilitating collaboration between the key players involved in health research, including universities, research centres, the pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators. IMI is the world’s biggest public-private partnership (PPP) in the life sciences.
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