Secondary Endpoints

When are they released?

There is a lot of discussion on when secondary endpoints in clinical trials are released.

Many people believe they should be released when the primary endpoints are released. But this is rarely the case.

While specific regulatory guidance could not be found, there are examples of how companies have released their secondary endpoints.

In summary secondary endpoints are often not released the same time as primary endpoints.

Take Albireo (ALBO) as an example. They announced the results from their P3 trial on Sept 8, 2020.

This PR only announces topline results (yellow highlight). And the company says they will provide complete results in the future (green highlight).

Then on Nov 13, 2020 (2 months later) the company announced the following PR outlining the secondary's and providing some metrics.

While they did give some specific data in this PR, they last highlight indicates they will outline all results at the AASLC conference.

While this is just one company, this seems to be the norm as far as releasing topline data immediately and releasing secondary endpoints down the road.