The approval agency EMA does not collect individual patient data as a standard
So are these troves of data just out there unused by the manufacturers? In any case, medical journals do not receive the IPD as a criterion for the studies they publish, says Beate Wieseler of IQWiG.
This leaves the regulatory authorities who approve new drugs such as vaccines. The Food and Drug Administration (FDA) is the last word in the United States. “The FDA requires that you provide that individual patient data. That data is then also used by the FDA to do its own analyses,” Weissler says.
In the European Union, the European Medicines Agency (EMA) is responsible. There, vaccine manufacturers applied for and gained approval for their products. Unlike the FDA, the EMA does not require IPD as a standard in the approval process, the authority responds to the #Faktenfuchs request. When asked why this is not the case, EMA refers to an EU directive that regulates the approval of medical products. It is not required to provide such data.
Experts believe that one of the reasons for this may be too much work. EMA lacks the staff to analyze this data itself by default. “One must definitely say that this is also a resource-intensive procedure that is not currently available in EMA,” says Beate Wieseler. Wiesler believes it would make sense if the EMA was provided with enough staff and equipment to deliver this standard.
However, EMA can request patient data at any time
However, the EMA can request and view individual patient data for studies at any time during the approval process, the authority writes upon request. #Faktenfuchs asked six vaccine manufacturers about it. AstraZeneca only answers this question: “AstraZeneca has submitted the datasets to EMA as part of its marketing authorization requirements.”
In addition, the EMA writes, a pilot project is currently underway at the agency: the goal is to see if “raw data” analysis improves the approval process and other monitoring steps.
Another important argument in the publication of IPD, which is not only related to EMA, is the data protection of study participants. More on that later in the text.