Common design considerations when involving particular ethnic groups in trials

Learning from completed INCLUDE Ethnicity Frameworks

The INCLUDE Ethnicity Framework aims to help trial teams think specifically about which ethnic groups should be included in their trial for its results to be widely applicable, and what challenges there may be to making this possible. 

One of the potential challenges of using the INCLUDE Frameworks is the time taken to complete them.  Having completed over 25 Frameworks for different sorts of trials our STRIDE project looked across the completed Frameworks for challenges that are common regarding including particular ethnic groups when doing trials in a range of clinical areas.

We have nine summary documents, which are given below.  Each document considers a clinical area (e.g. cancer trials) and then lists challenges we have identified for the five ‘headline’ ethnic groups used in the UK by the Office of National Statistics: 

1. Asian/Asian British
2. Black/African/Caribbean/Black British
3. Mixed/Multiple ethnic groups
4. Other ethnic groups
5. White

Each summary document collates what we found in the INCLUDE Frameworks for each ethnic group for the clinical area.  Clearly these groups are very broad and that should be remembered when reading the documents.  

We think these documents can be a shortcut if time is very short: if you look at these documents you’ll get an idea of things you need to think about without having to do any new work. There may be things missed for your trial, but it’s likely that you’ll have a better idea of things you need to think about than you would have had you not been able do anything at all.

If you have any feedback on the summary documents, we be happy to hear from you at info@trialforge.org.

Many thanks to Bārbala Ostrovska for creating these summaries.