It's still being bandied about that Amarex is analyzing the data for the interim and also that Cytodyn will get absolutely no information unless the trial is stopped for efficacy. Wrong on both counts.
https://www.fda.gov/media/75398/download
Now we come to what will it take for the DSMC to stop the trial and recommend submittal to the FDA.
https://www.drugabuse.gov/research/clinical-r...monitoring
Quote:Another important issue relating to the role of the statistician arises when the statisticianis employed by the sponsor. Elsewhere in this guidance, we have described the concerns associated with sponsors being aware of the interim comparative data. For purposes of quality assurance, sponsors often wish to maintain control of the data and have their own statisticians perform the analyses, including the unblinded analyses for the DMC. Typically and appropriately, such statisticians are instructed not to disclose interim data to others within the sponsoring organization. Questions can always arise, however, as to whether the statisticians are adequately separated from others within the sponsoring organization involved in managing the trial.
For these reasons, the integrity of the trial may be best protected when the statisticians preparing unblinded data for the DMC are external to the sponsor and uninvolved in discussions regarding potential changes in trial design while the trial is ongoing. This is an especially important consideration for critical studies intended to provide definitive evidence of effectiveness. Balanced against this concern, however, is the need for the statisticians reporting to the DMC to be very familiar with details of the study and have ample opportunity to assess the interim data. The primary trial statistician, whether or not employed by the sponsor, is usually best situated to play this role. We recognize that an external statistician contracted by the sponsor to perform interim analysis may not be
entirely free from the types of pressures and concerns that may affect a statistician employed by the sponsor.
Quote: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
https://www.fda.gov/media/75398/download
Now we come to what will it take for the DSMC to stop the trial and recommend submittal to the FDA.
Quote:For studies that are conducted in a blinded manner, the presentation of data relating specifically to outcome measures should be presented to the DSMB in the manner and timing described in the DSMP for that study. Studies that include interim analysis of efficacy data should provide the proposed number of interim analyses to be made, the specific comparisons to be made at each such analysis, the stopping rules on the basis of efficacy findings, including both standards for the determination of 'overwhelming efficacy' and an 'inevitable failed trial', and the methods of statistical correction to be used to control the final overall Type 1 error.
The presence of early unanticipated therapeutic results, side effects or adverse consequences and independently make recommendations to continue, to amend or to terminate a clinical trial based on the interim analysis for efficacy (e.g., terminate a clinical trial because it would be unethical to continue the non-treatment/ treatment as usual arm).
https://www.drugabuse.gov/research/clinical-r...monitoring
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