COVID-19 vaccines: individual patient data should be submitted to the European Medicines Agency

BMJ

24 February 2022 - An interesting letter to the Editor of the BMJ from the Head of Drug Assessment at the IQWiG.

By reiterating the call from 2009 for raw clinical study data, Doshi and colleagues point out that, despite more than a decade of discussion, we are still struggling to adequately inform decision making in our health care systems.

There has undoubtedly been progress. But the achievements so far mainly apply to aggregate data, not to anonymised individual patient data (IPD). In its 2013 transparency initiative, the European Medicines Agency planned for access to IPD, but we are still waiting for progress on this.

Read BMJ article

Michael Wonder

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Michael Wonder