Clinical Trial End Date

I have a question for some of the clinical trial guys. Randy has been on the EMBARK trial since October of 2016. Right now he's on Lupron and either Enzalutamide or a placebo. Since it's a double-blind study, we don't know for sure. There has been zero progression while he has been on this trial. Per the NIH website, the trial was scheduled to end in 2020. We've asked our clinical trial coordinator how much longer we can expect the trial to continue, and she just doesn't know. We do know that there are only 2 folks still in the trial at Emory, and the other guy is no longer on any meds. Does anyone know how the end date is determined for clinical trials? Are they likely to just end it some Monday afternoon when we come in for our visit? Is it usual for trials to continue past their published end date?

Thanks, Donna.

Wow! Close to five years! Well, the great news is no progression. Congratulations!

PS, so they actually have placebos for the four big Enzalutamide pills I swallow every day?

The page does have April 23, 2021 as the date the page was last updated, but we don't know what changes were made. The end dates are a logical assumption.

When a study with an experimental (non-approved) medication ends, the sponsor usually lets those getting the medication continue on it (still free) if they are deriving benefit. In some ongoing studies, those who progress are withdrawn and often unblinded. The study may have a crossover arm that these patients can join if they wish to try the study medication.

In this case, since the medication in the experimental arm is commercially available, I don't know what the sponsor will do. They can certainly afford to continue to supply it free (especially since they make it). I think the odds good that they will, and possibly both drugs.

Djin