NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Not really dennisdave. You and I are both correct when we say this:

1. NWBio used an External Control Arm (ECA), when they did the analysis of the DCVax-L Phase III clinical trial results.

2. The regulatory authorities, including the MHRA and the FDA, do not and will not have a problem or issue with the ECA that NWBio used.

But, you are flat wrong when you say that NWBio used Real World Data (RWD) or Real World Evidence (RWE).

You are also wrong when you say that NWBio used a historical ECA. Instead, NWBio used pooled control group data from other peer-reviewed and published contemperaneous (not historical) randomized controlled trials (RCTs).

The MHRA specifically and clearly says that RWD and RWE does not include data from clinical trials. Clinical trials are not real world. The MHRA says RWD can only be health related data “outside of a clinical study setting”.

You don’t have to take my word for it, you can go directly to the MHRA’s own guidance to learn what their definition of RWD and RWE is:

https://www.gov.uk/government/publications/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions

There are vast amounts of data being collected on patients, for example, in electronic health records (EHR), and disease and patient registries. Such data are commonly called RWD, reflecting that they are collected while patients go about their regular lives, as opposed to being specifically collected in a clinical study. When such data are analysed, the information produced may be referred to as real-world evidence (RWE).
For the purposes of this series of guidelines, RWD are defined as data relating to patient health status or delivery of health care collected outside of a clinical study. Sources of RWD include electronic healthcare records (EHR) defined as structured, digital collections of patient level medical data, primary and secondary care records, disease registries, and administrative data on births and deaths. Other sources of RWD include patient reported outcomes (PRO) data and data which are collected outside of a clinical study setting such as through wearable devices, specialised/secure websites, or tablets.
The MHRA is producing a series of guidelines to provide general points to consider for sponsors planning to conduct clinical research using RWD to support regulatory decision making.