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. Author manuscript; available in PMC: 2015 Jan 1.
Published in final edited form as: J Biopharm Stat. 2014;24(5):968–975. doi: 10.1080/10543406.2014.925719

Table #1.

A Dozen of the Common Myths that can Adversely Impact DMC Independence

  • DMC procedures must rigidly follow the DMC Charter

  • DMCs use ‘stopping rules’ rather than ‘monitoring guidelines’

  • The number and timing of DMC meetings are fixed in advance

  • The content of DMC Open and Closed Reports is rigidly pre-specified

  • The DMC chair and others in leadership roles needn’t be experienced in the DMC process

  • DMC meetings always should begin with an Open Session

  • The sponsor or contract research organization should lead the DMC Open Session

  • DMC members are consultants for the trial’s sponsor

  • DMC members should indemnify the trial’s sponsor and contract research organizations

  • Special efforts are not required before each meeting to ensure currentness of DMC reports

  • DMCs should review ‘blinded’ data on efficacy and safety measures

  • DMCs take formal ‘votes’ when developing their recommendations