FDA recently updated its archive of Good Clinical Practice queries from the public. The spreadsheet includes the questions, responses, date received, category, and keywords. There is a lot of interesting content here, but we wanted to take a high-level look at the trends in topics raised by questioners.
Unfortunately, most questions in 2017 and 2018 were classified as “General GCP,” which is not useful in discerning trends. Excluding that category, the most popular GCP questions to FDA concern informed consent, followed by IRB matters, electronic systems (a category charmingly referred to as “Computer Questions” in 2017 and 2018), 1572, Training, Adverse Events, and clinicaltrials.gov. Here’s the full list:
The biggest movers in terms of emerging topics were IRB (a big jump in questions from 2020 to 2021); clinicaltrials.gov (ditto); subject recruitment/withdrawal; and (of course) COVID.
Topics that appear to be losing steam are Form FDA 1572, training, and adverse events.
In our next post, we’ll do a linguistic analysis on how FDA answers questions.