AI
Monday, August 18, 2025 9:25:35 AM
I thought I would help settle this argument once and for all. I wrote the following email to the MHRA back in May:
I have read your most recent draft guideline regarding the use of external control arms based on Real World Data (RWD) and have just noticed this week that you are holding a consultation into this subject is now underway to support regulatory decisions. I have two questions that I would like answered for better clarification and understanding please:
1. If the sponsor of a new biologic uses the pooled overall survival (OS) results of external control arms (ECAs) from several other contemporaneous randomised controlled trials (RCTs) as the control group for its clinical trial (where care has been taken to use RCTs with similar exclusion and inclusion criteria), would the use of this ECA be considered RWD or Real World Evidence (RWE) or something else?
2. Under the MHRAs existing regulatory framework, can an MAA (which is already under review and is based on the Phase 3 trial data that includes the sort of trial outlined in 1 above) be approved, or would it need to wait until the final guideline on the use of of external control arms based on RWD is published?
And I have just had a reply:
Simply leaving this here for others to hash out, but it seems pretty clear to me!
I have read your most recent draft guideline regarding the use of external control arms based on Real World Data (RWD) and have just noticed this week that you are holding a consultation into this subject is now underway to support regulatory decisions. I have two questions that I would like answered for better clarification and understanding please:
1. If the sponsor of a new biologic uses the pooled overall survival (OS) results of external control arms (ECAs) from several other contemporaneous randomised controlled trials (RCTs) as the control group for its clinical trial (where care has been taken to use RCTs with similar exclusion and inclusion criteria), would the use of this ECA be considered RWD or Real World Evidence (RWE) or something else?
2. Under the MHRAs existing regulatory framework, can an MAA (which is already under review and is based on the Phase 3 trial data that includes the sort of trial outlined in 1 above) be approved, or would it need to wait until the final guideline on the use of of external control arms based on RWD is published?
And I have just had a reply:
Simply leaving this here for others to hash out, but it seems pretty clear to me!
