Defining "data gathering is complete" for trials
-
As a follow up to question [223], if an ongoing study has a primary endpoint completion in November 2023, an interim data read out in January 2024 and is planned to fully complete in 2025, when do we have to stop discussing the trial? Is it in January at the read out as the study is not fully complete to 2025? Or is it at the primary endpoint completion?
-
As a follow up to question [223], if an ongoing study has a primary endpoint completion in November 2023, an interim data read out in January 2024 and is planned to fully complete in 2025, when do we have to stop discussing the trial? Is it in January at the read out as the study is not fully complete to 2025? Or is it at the primary endpoint completion?
Hello @jennifer_bco
In 223 response, there is a line that states: “The PAAB defines ongoing studies as studies which are still within the data gathering stage. It is important to note that once data gathering is complete, or an interim analysis is conducted, we no longer consider the study to be "ongoing" even if data has not been published or made public.”. The PAAB Code also defines ongoing studies in section 1.8. Based on the description above, it seems that as of November 2023 discussion of the ongoing study would no longer be acceptable.
-
Hello @jennifer_bco
In 223 response, there is a line that states: “The PAAB defines ongoing studies as studies which are still within the data gathering stage. It is important to note that once data gathering is complete, or an interim analysis is conducted, we no longer consider the study to be "ongoing" even if data has not been published or made public.”. The PAAB Code also defines ongoing studies in section 1.8. Based on the description above, it seems that as of November 2023 discussion of the ongoing study would no longer be acceptable.
@jennifer-carroll Can you point me to section 8 of the code as I could not find it on the website or when I downloaded the "flattened" version of the code.
-
@jennifer-carroll Can you point me to section 8 of the code as I could not find it on the website or when I downloaded the "flattened" version of the code.
@jennifer_bco apologies. That should have read 1.8 (I've now fixed it). You can also find it by searching "ongoing".
-
@jennifer_bco apologies. That should have read 1.8 (I've now fixed it). You can also find it by searching "ongoing".
