Based on the explanation below, even if this recom

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Based on the explanation below, even if this recommendation is granted, I believe a separate request for emergency approval still must be submitted to the FDA which, of course, could be still denied though I'm not sure how often that scenario occurs.

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The sponsor (CYTODYN) and/or trial steering committee generally appoint members of a DMC. Factors to consider in the selection of individuals to serve on a DMC typically include relevant expertise, experience in clinical trials and in serving on other DMCs, and absence of serious conflicts of interest as discussed below. The objectives and design of the trial and the scope of the responsibilities given to the DMC determine the types of expertise needed for a particular DMC.

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Most DMCs are composed of clinicians with expertise in relevant clinical specialties and at least one biostatistician knowledgeable about statistical methods for clinical trials and sequential analysis of trial data. For trials with unusually high risks or with broad public health implications, the DMC may include a medical ethicist knowledgeable about the design, conduct, and interpretation of clinical trials. Prior DMC experience is important when considering the committee as a whole; it is highly desirable that at least some members have prior DMC service. Prior DMC experience is particularly important for the statistical DMC member if there is only one statistician serving on the DMC. Some trials may require participation of other types of scientists. Toxicologists, epidemiologists, and clinical pharmacologists, for example, could be included in particular cases when such expertise appears important for informed interpretation of interim results.

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Generally, such a DMC member would not also be a participant in the trial, since awareness of the accumulating data could affect compliance or other aspects of trial participation. Rather, the member could be someone with the disease or condition under study or a close relative of such an individual, for example.

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Conflicts of interest deserve special consideration in choosing individuals to serve on a DMC. The most obvious conflict is financial interest that could be substantially affected by the outcome of the trial.

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The sponsor (CYTODYN )often appoints the DMC chair, but may seek advice from trial investigators or trial steering committee members. Prior DMC experience is more important for the chair than for other DMC members, as members will look to the chair for leadership on administrative as well as scientific issues. Sponsors will typically want to select a chair who is capable of facilitating discussion, integrating differing points of view, and moving toward consensus on recommendations to be provided to the sponsors. Sponsors may also want to be assured that a potential chair is willing to make a firm commitment to participate for the duration of the trial (or for the term of the appointment, for chairs of DMCs monitoring multiple trials).

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