What are the best approaches to ensure inclusion and participation of under-represented or vulnerable groups in randomised trials?
Under-represented or vulnerable groups might include, for example, children or people with rare diseases. This uncertainty is not about doing trials in these populations, exclusively, but about including participants from these groups where they are eligible as part of a ‘wider’ target population (e.g. the general public).
- “It is easy to try to keep trial costs down by only targeting those who are easiest to recruit. There should be a reviewer at the stage of NIHR applications who explicitly has to provide feedback on the extent to which a study contributes to understanding (or not) the wider application of the proposed study.”