Ensuring a trial has an independent data monitoring committee (DMC) is crucial to the safety and oversight of clinical trials. But a question this week was whether there is ever a scenario where a DMC might legitimately be deemed not to be essential 1/8 #MethodologyMonday #110 - ThreadSky

marionkcampbell.bsky.social • 26 days ago

Ensuring a trial has an independent data monitoring committee (DMC) is crucial to the safety and oversight of clinical trials. But a question this week was whether there is ever a scenario where a DMC might legitimately be deemed not to be essential 1/8
#MethodologyMonday #110

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marionkcampbell.bsky.social•26 days ago

The role of an independent DMC is to review accumulating data in a trial for evidence of any emerging safety issues or whether there is sufficient evidence that a trial should stop early for benefit or harm (or indeed futility) 2/8

marionkcampbell.bsky.social•26 days ago

A DMC’s role is primarily in the recruitment phase of a trial in order to protect any future potential participants from being unnecessarily enrolled in the study (if sufficient evidence has been reached) or from exposure to potential harm (should a harm signal be identified) 3/8

marionkcampbell.bsky.social•26 days ago

The independent DMC role is thus very important and the expectation rightly is that a DMC is routinely required for all trials 4/8

marionkcampbell.bsky.social•26 days ago

However, there are a few scenarios where, exceptionally, it has been accepted in the literature that it may not be feasible/essential for a DMC to be set up. These were described in the DAMOCLES project which reviewed all aspects of DMCs 5/8
https://www.journalslibrary.nihr.ac.uk/hta/HTA9070

marionkcampbell.bsky.social•26 days ago

These exceptional reasons included eg short trial duration where events for
patients would all accrue before the DMC could provide input, where there are only v minor hazards from the treatments eg administrative studies & trials aimed at demonstrating a biologic principle 6/8

marionkcampbell.bsky.social•26 days ago

However, as Sydes et al note, should an independent DMC deemed not to be essential, the rationale for this must be fully justified in the protocol and agreed before the start of the trial. 7/8
https://journals.sagepub.com/doi/epdf/10.1191/1740774504cn004rr

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