More oopsies in the world of court-ordered released data
This latest data quest literally took me all day. I dove back into the continuing saga of the Pfizer documents slooooooowwwwwwly being released. I must say, releasing the data in such an obtuse way, month-by-month, makes it very difficult to assess. A stroke of inane genius. The structure, or lack thereof, the data, and even the file types, also makes analysis extremely difficult.
So, let us return together to the Pfizer documents released by the Public Health and Medical Professionals for Transparency found here.
The reader will note that there are a few listed Case Report Forms (CRFs) for specific sites where the clinical trials were taking place. Sites such as 1081, 1096 and 1128 as listed below.
Now, most of you know that Pfizer is under court order to release their safety and efficacy documents to the public. So far, we, the public, have received a pittance, and what we have received is akin to Enigma. Even Alan Turing would be perplexed. But not really.
What we have been given so far are 10 pages containing a list of 238 documents of varying type and content. Let us now focus only on the files that pertain to sites and the number of ‘Subject No:’s (Subject numbers) per site as organized/revealed here in the ‘interim-mth6-randomization-sensitive’ document which provides a list of randomization numbers for the participants. I will use the words ‘Subjects’ and ‘IDs’ interchangeably.
I don’t want to beat around the bush here. There are hundreds of Subject numbers missing if we assume that every participant actually has a CRF written for them. It is my understanding that every trial participant must have a CRF (ICH GCP1 2). I compiled the data and made a comprehensive table to put the totals in one place to show what is missing. There are a total of 9 sites revealed so far (as of May 2, 2022) of 158, by my count from here. Of these sites, in the column labeled Total_No_IDs, are the numbers of Subjects (same as IDs) meant to be accounted for, for a particular site according to this document. As you can see in the column labeled No_IDs_Released, the number of Subjects is much less than what it should be. The percentages of Subjects actually accounted for are all under 6.6%! In the case of the Ventavia Research Group for site 1085, a mere 1.4% of Subjects are accounted for. Since Pfizer is under court order to release complete lists, what on earth is going on here? Are these the complete lists? If these are the complete lists of Subjects, then where did the data relating to the hundreds of other Subjects/participants go?
I literally felt a bit stomach sick going through this today. The number of inconsistencies is so beyond alarming and this is just the tip of the iceberg. And we all know what happened to poor Titanic. I love that movie.
P.S. Does anyone actually know if every single participant even gets assigned a CRF?
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