NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Dr. Linda Liau was specifically referring to the FDA’s requirement to provide patient-level data if a Sponsor uses real world data (RWD) in their clinical trial analysis, as their external control arm (ECA).

Dr. Linda Liau specifically said:

patients on study would have to be matched with a patient from a database, and as we pursued the databases that were out there, which is kind of surprising to us, there is not enough data to match these individual patients

Let me slowly explain to you what Dr. Linda Liau said and what it meant:

(1) NWBio and Dr. Linda Liau originally considered using real world data (RWD) to build their ECA and perform their analysis of the DCVax-L Phase III trial results.

(2) NWBio and Dr. Linda Liau looked at several available RWD databases from several RWD providers, which consisted of information gathered from diverse sources like electronic health records (EHRs), claims data, patient registries, etc.

(3) The FDA guidance requires that any RWD used to build an ECA, and used to review and analyze clinical trial results, must have patient-level data.

(4) Upon examining these available RWD databases, NWBio and Dr. Linda Liau discovered that patient-level data was not available in these RWD databases.

(5) As a result, NWBio and Dr. Linda Liau decided not to use any RWD to build their ECA and to analyze the DCVax-L Phase III trial results, instead they decided to use pooled control group data from external concurrent and contemporaneous randomized controlled trials (RCTs) to develop their external control arm (ECA).

What NWBio and Dr. Linda Liau did was a stroke of genius, and it averted and avoided the FDA’s requirement of needing to have patient-level data, because they did not use any RWD or RWE databases in the DCVax-L Phase III trial.