So today's meeting could potentially be one of the
Post# of 155128
(Total Views: 890)
Posted On: 08/03/2020 6:52:17 PM
So today's meeting could potentially be one of the preliminary meetings.
Another thing I found in the DMC guidelines is that the DMC reports their findings directly to the sponsor, which of course in this case would be Cytodyn, as shown on page 24:
A fundamental responsibility of a DMC is to make recommendations to the sponsor (and/or, as noted in the Introduction, a steering committee or other group delegated by the sponsor to make decisions about the trial) concerning the continuation of the study. Most frequently, a DMC’s recommendation after an interim review is for the study to continue as designed. Other recommendations that might be made include study termination, study continuation with major or minor modifications, or temporary suspension of enrollment and/or study intervention until some uncertainty is resolved.
Because a DMC’s actions potentially impact the safety of trial participants, it is important that a DMC express its recommendations very clearly to the sponsor. Both a written recommendation and oral communication, with opportunity for questions and discussion, can be valuable. Recommendations for modifications are best accompanied by the minimum amount of data required for the sponsor to make a reasoned decision about the recommendation, and the rationale for such recommendations should be as clear and precise as possible. Sponsors may wish to develop internal procedures to limit the interim data released by a DMC after a recommendation until a decision is made regarding acceptance or rejection of the recommendation, to facilitate maintaining confidentiality of the interim results should the trial continue. We recommend that a DMC document its recommendations, and the rationale for such recommendations, in a form that can be reviewed by the sponsor and then circulated, if and as appropriate, to IRBs, FDA, and/or other interested parties. Sections 5 and 7.2.1 address implications for reporting to FDA of DMC recommendations for major study changes such as early study termination.
So if today's meeting is not preliminary, and the DMC does recommend an efficacy stop, that recommendation would go straight to Pourhassan.
No way he could keep quiet about that LOL!
I doubt Pourhassan could keep quiet about a DMC recommendation to continue the trial
Another thing I found in the DMC guidelines is that the DMC reports their findings directly to the sponsor, which of course in this case would be Cytodyn, as shown on page 24:
A fundamental responsibility of a DMC is to make recommendations to the sponsor (and/or, as noted in the Introduction, a steering committee or other group delegated by the sponsor to make decisions about the trial) concerning the continuation of the study. Most frequently, a DMC’s recommendation after an interim review is for the study to continue as designed. Other recommendations that might be made include study termination, study continuation with major or minor modifications, or temporary suspension of enrollment and/or study intervention until some uncertainty is resolved.
Because a DMC’s actions potentially impact the safety of trial participants, it is important that a DMC express its recommendations very clearly to the sponsor. Both a written recommendation and oral communication, with opportunity for questions and discussion, can be valuable. Recommendations for modifications are best accompanied by the minimum amount of data required for the sponsor to make a reasoned decision about the recommendation, and the rationale for such recommendations should be as clear and precise as possible. Sponsors may wish to develop internal procedures to limit the interim data released by a DMC after a recommendation until a decision is made regarding acceptance or rejection of the recommendation, to facilitate maintaining confidentiality of the interim results should the trial continue. We recommend that a DMC document its recommendations, and the rationale for such recommendations, in a form that can be reviewed by the sponsor and then circulated, if and as appropriate, to IRBs, FDA, and/or other interested parties. Sections 5 and 7.2.1 address implications for reporting to FDA of DMC recommendations for major study changes such as early study termination.
So if today's meeting is not preliminary, and the DMC does recommend an efficacy stop, that recommendation would go straight to Pourhassan.
No way he could keep quiet about that LOL!
I doubt Pourhassan could keep quiet about a DMC recommendation to continue the trial
(1)
(0)