Created on Tuesday, 12 Nov 2019. Posted in Funding
This month's update from HTA addresses who should be included in clinical trials in relation to multi-morbidity.
Multiple long-term conditions are not easy to research as the understanding of disease clustering whether genetic, early risk factors or attributes of age, poverty and geography is still at an early stage, but what we can do is be more vigilant as to who we include in clinical trials. Unless there are very good reasons to exclude people then researchers should strive to include those who are often in the past been excluded from trails such as those with multiple long-term conditions.
It’s recognised that being more inclusive might result in slightly larger sample sizes and data from efficacy studies might not be the best on which to base planned sample size calculations but we need to try and base our clinical trial plans on as much real world NHS data as possible.
Also including lots of different people in clinical trials risks diluting the ability to detect changes, as some groups are less likely to benefit from the intervention or they may have much poorer follow up data, but we must do what we can to achieve a reasonable balance.
HTA will be looking carefully at exclusion criteria in applications. Study populations should be a sensible balance between feasibility, cost and the ability to generalise to the wider NHS population.