Anne Plunckey

Gaps in the register

2016-11-14

Something I came across while cross-referencing EudraCT entries with approval timelines. Three entries that were present when I checked last quarter are no longer in the register. Not concluded, not terminated. Withdrawn, which removes the summary record.

This is diffrent from a trial ending. A concluded trial stays in the register with its results. A withdrawn trial is removed as if it was never there. The protocol number remains allocated but the public-facing record is gone.

I have been keeping my own copies of the summaries so I can confirm they existed. The three entries were under different sponsors and different therapeutic areas. The withdrawal dates, so far as I can determine them, fall within the same week.

  1. A sponsor can withdraw a trial registration.
  2. An authority can request withdrawal.
  3. In practice it is not always clear which happend.

Probably nothing. But it is the kind of thing I would want to know about if I were monitoring those products.