Covid-19 vaccines and treatments: we must have raw data, now
I’m a software consultant for Pharma companies and have worked on projects that used the same kind of study design as the Pfizer COVID vaccine (Kaplan-Meier).“Raw data” is submitted to the FDA in the CDISC format. This format contains a lot of pretty sensitive medical information, including which diseases a patient has, their medical history, what drugs they take, etc. This is supposed to be anonymized, but if the public were to be able to get this info, I strongly believe there is enough information to re-identify patients. And it’s not as simple as just removing the sensitive medical data because the primary or secondary analyses may be dependent on them.