ResearchAE.com (Social Health Insights)
In June, subscribers to our newsletter read this rather enthusiastic announcement:
While you're strolling the pharmacy aisles, or talking to your doctor about a prescription, wouldn't it be helpful to know about the adverse events associated with a drug, the demographics of people who experienced them, and what they were taking the drug for?
Now you can.
Now you can.
I’m still enthusiastic. ResearchAE.com makes it easy to search and analyze millions of drug and medical device adverse events, food and medical device recalls, and more. As an example, from the more than 8 million AE records available in openFDA (FDA’s open data API initiative), in a matter of seconds I was able to find all AEs associated with hospital stays for women my age who took cyclobenzaprine last year for muscle spasms. There was one. That’s quite an improvement over the weeks it could take to get the same information via a Freedom of Information Act request.
Data Dashboard (FDA)
- How many inspections were conducted in Italy in the past 5 years?
- What proportion of CDER inspections resulted in voluntary and official action indications in 2012?
- How many warning letters were sent by CDRH in last year?
- How many Class I food recalls were there in 2010?
The FDA Data Dashboard can be used to quickly answer any of these questions. High-level data about inspections, warning letters, seizures, injunctions, and recalls are displayed graphically, with options to filter results by year and center. The user can then drill down to view lower levels of detail in tabular form and sort the data by column of interest. Finally, the charts and tables can be exported if further independent analysis is required.
Trends, Charts, and Maps in ClinicalTrials.gov (NIH)
While not nearly as interactive as the previous sites, this page deserves an honorable mention. It provides some interesting data summaries about clinical trials at a glance. Visitors can view charts and diagrams that show the total number of registered studies by type and year, and the number of registered studies with posted results. The map feature that shows global study locations is the sole interactive piece. It’s easy to use and once you’ve drilled down to the country level, a subsequent mouse click will kick off a clinicaltrials.gov query for all studies registered there.
It is possible to download raw XML-formatted data directly from ClincalTrials.gov. With that, a developer could build any additional trend analysis required. Since I personally haven’t written a line of code since the Clinton administration, I’ll stick to clicking the interactive map.
Just before the new year, FDA announced the availability of a consolidated, searchable database of all guidance documents issued by the agency. Previously, lists of guidance documents were strewn across the FDA website and were inconsistently organized across centers. I’ve always found these lists nearly impossible to navigate (though I admit my fellow Polaris colleagues have fared better). You’d be hearing my celebratory “woot woot” from here if it weren’t for a few tweets I read recently that identified a number of guidance documents missing from the database. There’s speculation that FDA may still be populating it, so I remain hopeful about the database’s usefulness, and will check back periodically to see how it’s progressing.