Replies to post #464485 on Anavex Life Sciences Corp (AVXL)

[Hoskuld]

There are two typical ways to handle OL data: 1) see it as it rolls in or 2) not see it until the very end. The former way is fraught. These two paragraphs from an FDA presentation say it succinctly:

It is critical to prevent access to accumulating subject-level and
group-level study data that includes information on treatment
assignment (either with the treatments identified or with codes such as
“A” and “B”) outside of an external independent DMC and a supporting
independent statistician(s) who prepares interim reports.

Knowledge of comparative summary-level interim outcome results by
subjects, investigators, the sponsor, or the public can negatively impact
trial conduct (e.g., recruitment, adherence, and retention) and impair
ultimate interpretation of results.