Using regulatory data

In my recent post I expressed frustration with the direction of travel of rapid reviews and one thing I highlighted was the lack of work on using regulatory data.  This prompted two responses highlighting two separate papers:

The latter reports:

Regulatory reviews (e.g., U.S. Food and Drug Administration [FDA], European Medicines Agency) include data about trials of drugs, biologics, and medical devices submitted by manufacturers for marketing approval. They sometimes include data about trials not reported in journal articles. Studies comparing regulatory reviews with journal articles about antipsychotics and antidepressants found that some trials considered “negative” or “inconclusive” by regulators were reported as “positive” in journal articles. In the MUDS study, we found that regulatory reviews may not be a good source of information about harms for use in meta-analysis. The FDA Medical Review and Statistical Review of gabapentin for postherpetic neuralgia (available from Drugs@FDA) both reported pooled data about harms, but neither included the results for each individual trial. Additionally, regulatory reviews do not contain data about trials conducted after marketing approval. We recommend you check regulatory reviews when conducting a systematic review on a regulated product (e.g., drugs, biologics, and devices) to determine whether they contain trials not reported elsewhere.”

While the former is more of a guide (and of more practical use), reporting:

  • There is compelling evidence that published trial information is selectively reported and that results not showing favourable effects of the tested treatments often remain unpublished
  • Clinical trial information published by regulatory authorities such as the US Food and Drug Administration (FDA) may help to reduce such reporting biases
  • FDA approval documents are long and do not follow the typical structure of medical journal articles, which may discourage reviewers from using them for evidence syntheses
  • Our practical guidance on how to efficiently identify and use approval documents to find the relevant information may help promoting the use of this valuable data source for evidence syntheses


FDA (and EMA) reports have great potential – in some areas. The ideal moment is when a new product has been approved – as the evidence is likely to be up to date (as far as I know regulators don’t require constant, post-approval, updating from manufacturers).  The Brexpiprazole review was a case in point, it took 60-90 minutes – including the production of a meta-analysis.  After that, more typical updating techniques are likely required to keep the review up to date.

If we free emancipate ourself from review groupthink we’ve got a reasonable chance of doing rapid reviews reasonably rapidly. Now, that’s novel….


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