NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Thanks FCB.


I agree with your analysis on the statistician side of the DMC. However, I do not believe the statistician is blinded from the discussions with other members of the board. Therefore, it seems the statistician is required to compartmentalize his two tasks. 1. Statistics. 2. Obtain enough information to vote. If he lets #2 creep into #1 then there is a problem. The statistician is also not likely blinded from "open session" sponsored meetings, where the sponsor can share important external data.

So my thinking is that the board likely already attended an "open session", and its just my guess, but I bet the sponsors made very clear the distinguishing factors between the Provenge and IMUC trials. If not, the physicians likely already studied the two prior cases in depth.

"many DMC meetings include an "open" session in which information in the open report is discussed. These non-confidential data may include, for example, status of recruitment, baseline characteristics, ineligibility rate, accuracy and timeliness of data submissions, and other administrative data. Sponsors may also use open sessions to provide external data to the DMC that may be relevant to the study being monitored."

Section 4.3.1.2 -- Guidance for Clinical Trial Sponsors - Establishment and Operation of Clinical Trial Data Monitoring Committees

Looking at the DMC guidelines and reviewing some DMC surveys, I think the physicians rely upon the statistical results as well as other trial studies.

In the end, I think the physicians are likely to read every old study they can get their hands on. (I also think they probably comb the website for information.) However, they should not, according to the guidelines, exchange information with other ongoing DMC's, unless there are overriding concerns for safety or something else very pressing.