Sponsor Access to Interim Data11 Feb 2022 09:17
Whilst we wait for the results I went back over the FDA guidance with regard to Sponsors and clinical trial Interim analysis. There is a specific section within the guidance on Sponsor Access to interim Data which particularly relates around access for planning purposes (page 31).
We know that the interim analysis occurred around July/August and Ashfeild Engage were in the picture by end of September. It appears to me there has been great planning in the type of roles required for a US and EU launch that have subsequently been advertised by Ashfeild. Combine this with the new website and some hints around new manufacturers and it seems there has been a meticulous build up which didn't just start after the mid December unblinding.
I wonder if they talked with the FDA and took a little peak at the half way mark!
From the FDA guidance ........ "Often, sponsors wish to have access to unblinded interim data for the purpose of planning product development, e.g., designing/initiating further trials or making decisions regarding production facilities. This interest is understandable, but such access is problematic for reasons already discussed. In general, sponsors are advised to avoid seeking information about unblinded interim data because of the significant possibility that they may wind up impairing trial management or even making the trial results uninterpretable by doing so. Further, plans or decisions based on statistically imprecise interim data may often be suboptimal. Where the sponsor nonetheless has a compelling need to review such information, certain approaches may lessen, although they do not eliminate, risks to the trial"..... there is then a long list of measures to put in place if looking at the interim data.
Also...... "We recommend that sponsors contact FDA before initiating communication with the DMC regarding access to interim data from a trial likely to be an important part of a regulatory submission. While FDA permission is not required, a discussion regarding the potential risks and implications of that action and of methods to limit the risks may contribute to informed decision making."
https://www.fda.gov/media/75398/download
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