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Table 8 Recommendations for a minimal set of parameters to be reported and included in trial registries regarding DMC activities, Interim Analysis and Early Stopping *

From: A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials

Data Monitoring Committees and Interim Analysis*
Terminology
   Use of the standard nomenclature "Data Monitoring Committee"
Composition of the DMC
   Members' name, affiliation and training
   Independence status from research team and sponsor
Tasks of the DMC
   Whether the DMC reviewed and accepted the protocol before the start of the trial
   Main roles (e.g. monitoring of safety and/or efficacy), and explicit definition of which outcomes where analyzed#
   Any additional roles (e.g. monitoring recruitment, quality assurance)
   To which outcome(s) was the DMC blinded or unblinded
Interim Analysis and Statistical Monitoring Methods
   Whether the protocol included a predefined statistical monitoring plan
   Number of planned interim analyses
   Timing of planned interim analyses and parameter defining timing (i.e. participants or person-time recruitment, number of endpoints, ad hoc time interval)
   Type of analysis planned (i.e. efficacy, harm, futility, and/or sample size adjustment), specific statistical methods used (with references and uniform terminology), description of boundaries (i.e. their symmetry, p-value/confidence interval, and adjustment, if applicable), and outcome(s) to which they were applied (i.e. primary/secondary, any subgroup analysis)
   Any formal predefined stopping rules, to which outcome(s) did they apply, and whether they included statistical boundaries and/or other considerations
   Whether the statistical monitoring plan was completed as planned; if not, which changes were performed, and their rationale
   Adjustment for multiple analysis in final results (i.e. reported p-values and/or confidence intervals)
Recommendations to the sponsor/steering committee
   DMC recommendation regarding continuation or termination of the trial (with or without adjustments in protocol)
   Rationale (i.e. statistical boundaries and/or other considerations)
   Whether the sponsor followed the DMC's recommendations
Early terminated trials
   Motive(s) for termination (e.g. efficacy, harm, futility, recruitment)
   All previously stated items, particularly rationale for early termination (including predefined statistical monitoring plan, type of analysis, predefined stopping rules, and DMC recommendation), and adjustment for multiple analysis and early termination in final results
   Timing of early termination i.e which of the interim analyses led to trial termination, and on which parameter the timing of this interim analysis was based (e.g. number of participants enrolled, predefined number of endpoints)
   Planned and final sample size
   Total number of events after which the trial was terminated, including definition of these events
   Discussion of implications of early termination (i.e. concerning type I and II errors)
   Report early termination in the abstract of the paper
  1. †These recommendations are for main reports; further details could be available using other modes of publication (e.g. online appendices, trial design/protocol papers, web-based repositories), to which the report should refer to; planned items of this minimal set of parameters should be included in prospective trial registries.
  2. *Based on the book by Ellenberg et al, and the report of the DAMOCLES group [1],[2].
  3. #Particularly regarding safety-whether it included adverse events and/or main efficacy outcomes.