The serious adverse event (SAE) narratives section of a CSR is the most detailed description of serious adverse events one gets in clinical study reports.  They usually consist of a free-text description of the case, and in our experience generally run anywhere from a few sentences to page or so.

Should these be redacted before becoming publicly available?  The right answer is probably “it depends”.  But we’ve found that there are some starkly different approaches out there.

Consider GlaxoSmithKline.  GSK redacts SAE narratives in their entirety from CSRs it posts to its clinical study register.  Take study NCT00294047.  Here’s PDF p.112 of the publicly posted CSR:

Now consider FDA.  It releases SAE narratives—in this case, deaths–with almost zero redactions.  For example, see this report (FDA medical officer review of  omadycycline PDF p.312), where the only element redacted is the patient’s ID number:

What do you think?  Who’s got the right approach here?