Q. How can I identify the studies used to support an FDA approval application?


I'll outline one possible approach.  It's possible that a pharamcist working in a drug information center might know of an easier approach.  I spend a lot of time dealing with drug-related information questions but certainly do not get the exposure to drug information questions that someone laboring in the 'trenches' of a drug information center would accumulate.

I would start at the National Library of Medicine's "Drug Information Portal" (http://druginfo.nlm.nih.gov/drugportal/). This search interface serves as a gateway to many of the governments drug-related databases.  Search for the generic name of the drug of interest.  For example, golimumab (see figure 1).

figure 1

A screenshot of the "Drug Information Portal" search interface.


There are two of the results that will be useful.  Click first on the "Drugs@FDA" result (see figure 2).

Figure 2

A screenshot of the "Drug Information Portal" search results page.  The results of a search for -- golimumab -- are shown.


When the result page appears, you may first have to find and click on the form of the drug of interest to you.  If there is just one form, the page for that form will appear immediately.  Click on the link to the "Approval History...." (see figure 3).

Figure 3

A screenshot showing a link to the golimumab "Approval History, Letters, Reviews, and Related Documents."

When the "Approval History..." page appears, I would recommend that you first open the "Summary Review" (see figure 4).

Figure 4

A screenshot showing the link to the golimumab "Summary Review"


In the summary review, it is usually possible to find a description of the studies submitted in support of the approval application.  These study descriptions are often accompanied by study identification numbers (see figure 5).

Figure 5

A section of the review document.


As you can see, three study identification numbers are of interest for golimumab's approval to treat rheumatoid arthritis: C0524T05, C0524T06, and C0524T11.  


If the FDA approval in question is recent it is likely that you can find more information about these trials and any publications they produced by using ClinicalTrials.gov.  You can get to ClinicalTrials.gov using the link on your "Drug Information Portal" results page, or you can just enter clinicaltrials.gov in your internet browser's address bar.

I would recommend running an advanced search to see what sort of studies using drug of interest in the condition of interest have been registered by the drug's manufacturer.  Centocor produces golimumab (see advanced search entries in  figure 6).

Figure 6

A screenshot of a "ClinicalTrials.gov" search for golimumab trials.


Among the results, you may want to start by looking at the studies with posted results (see figure 7).

Figure 7

A screenshot of the ClinicalTrials.gov search results.  The "has results" notations are highlighted.


At the bottom of either the "Full text view" or "Results" (see figure 8) pages you will find citation information for articles that have been associated with the study and other subject identifiers (see figure 9)


Figure 8

A screenshot for a trial's record in ClinicalTrials.gov shows the location of the "Study Results" tab.



Figure 9 (from bottom of results page)

A screenshot of the bottom of the results page from a ClinicalTrials.gov trial record.


You would have to review the information in the FDA's "Review Summary" concerning study C0524T05 and the information in the cited publication/s to decide whether the automatic indexing to a specific publication is correct.    I didn't find study C0524T06 in ClinicalTrials.gov by reviewing the information on studies with posted results; I had to search for C0524T06.   I then found the ClinicalTrials.gov record for the trial and the automatically mapped publication associated with the trial.


  • Last Updated Dec 24, 2016
  • Views 36
  • Answered By Cindy Schmidt

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