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When to use a DMC, and when not to ... (DMCs).
TORONTO -- Not all trials have the same risks and therefore, not all require the same monitoring parameters, experts told the AAPS meeting here. So, DMCs are probably not needed in all studies.
From an FDA standpoint, DMCs are still not mandatory except in trials where informed consent cannot be taken, or in emergency use of drugs and devices.
According to FDA and industry speakers at AAPS' DMC session here Nov. 14, Phase I and II studies would not be candidate trials for DMCs. Those trials in which there are common symptoms and the trial is itself a short-term study are also cases where DMCs would not be recommended. Patient safety is not at issue, at least …
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