Impact of indication changes on scoping for European Union Joint Clinical Assessment: scale of the problem and how to address it.

Objectives: The European Union Joint Clinical Assessment (JCA) process aligns with the regulatory process to promote faster patient access. The PICO (population, intervention, comparator, and outcome) scoping for the JCA must occur before the regulatory process concludes. The risk of indication change during this period is one of the concerns for the success of the JCA process.

Discrete choice experiment to investigate preferences for incentives to promote antimicrobial research and development.

Objectives: Without intervention, experts predict that antimicrobial resistance will rank among leading drivers of mortality by 2050. New drugs are desperately needed, but given the lengthy development timelines for antimicrobial research and development (R&D), existing economic incentives fail to support a robust pipeline of new products. This study aims to elicit the preferences of stakeholders for adequate antimicrobial R&D incentive programs.