Q&A on general methodological and procedural issues for joint clinical assessments

The European Commission has published an updated version of its Questions and Answers on general methodological and procedural issues for joint clinical assessments. The Q&A includes responses to questions concerning:

• steps to be taken when available data does not permit an exact analysis of PICO (Population, Intervention, Comparator, Outcome) elements;

• the appropriate approach where the population included in a trial is wider than the population required in a PICO;

• the approach to adopt where no direct comparison is available for a specific PICO; and

• the consequences where a developer does not agree with a PICO included in the assessment scope.