Replies to post #627826 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Why is it that none of the FUD spreaders will respond to this post that cites the real experts? I’m talking about Ex, Learning Curve, Poorman, Legend, etc…..

Have posted many times.

1) External Control Arms in Oncology: Current Use and Future Directions

Including external controls for primary evidence of efficacy requires careful pre-specification of study design elements.

LITERATURE OR SUMMARY LEVEL DATA
. Not appropriate for direct comparison as external control to establish safety or effectiveness

Careful planning in the design phase before study initiation along with the implementation of a detailed protocol can ensure comparability of patient populations and data, such that the planned statistical analyses that adjust for residual biases can be reasonably relied on for better estimation of treatment effect in isolation.

2) Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products

Specific design elements to prespecify in the protocol (i.e., before conducting an externally controlled trial) include suitable study data sources,baseline eligibility (inclusion and exclusion) criteria,appropriate exposure definitions and windows, well-defined and clinically meaningful endpoints, cogent analytic plans, and approaches to minimize missing data and sources of bias

A specific design consideration for externally controlled trials involves prespecifying plans regarding how to measure and analyze data on important confounding factors and sources of bias

Plenty more concerns raised in those 2 sources (and others) straight from the FDA.