FDA (USA) Datasets on Clinical Trials

[todrobbins]

Here are a few resources which I’m sure some of you already know about:

• Premarket Approval (PMA) Clinical Trials Database
• New Pediatric Labeling Information Database
• “This list highlights key pediatric information from the studies submitted in response to pediatric legislative initiatives.”
• Post-Approval Studies

[rufuspollock]

@todrobbins really useful. Would you have any further info on each of these. E.g. description, size, openness.

[skram]

Also see clinicaltrials.gov (fact sheet: http://www.nlm.nih.gov/pubs/factsheets/clintrial.html) – they have a pretty good API.

There is also recent(ish) legislation to require studies to publish not only enrollment status but also results – see FDAAA 801 and the Final Rule - ClinicalTrials.gov