Group Sequential Design (GSD)
Reporting
Reporting of group sequential trials
Like other adaptive trials, the reporting of group sequential trials should adhere to the CONSORT extension for randomised trials that use adaptive designs (Adaptive designs CONSORT Extension, ACE) 1, 2.
The reporting of stopping rules and statistical methods for estimating treatment effect, uncertainty, and related measures of evidence (e.g., p-values) were found to be suboptimal in some group sequential trials 3. On the latter, it is unclear whether researchers are not using appropriate statistical methods despite the availability of methods and statistical software resources or they are just not reporting them. Furthermore, unplanned changes to the design and methods were difficult to assess because what was planned and unplanned was difficult to ascertain. To address these reporting deficiencies, researchers should specifically report, among other aspects described in the ACE reporting guidance:
The reporting of stopping rules and statistical methods for estimating treatment effect, uncertainty, and related measures of evidence (e.g., p-values) were found to be suboptimal in some group sequential trials 3. On the latter, it is unclear whether researchers are not using appropriate statistical methods despite the availability of methods and statistical software resources or they are just not reporting them. Furthermore, unplanned changes to the design and methods were difficult to assess because what was planned and unplanned was difficult to ascertain. To address these reporting deficiencies, researchers should specifically report, among other aspects described in the ACE reporting guidance:
- prespecified criteria for stopping the trial (e.g., either futility or efficacy) and the planned stopping rules as well as frequency and timing of interims analyses;
- decisions made at interim analyses and supporting interim results, as well as planned decisions that were not adhered to with explanation;
- statistical methods used for analyses at interim and final analyses to estimate treatments effects, uncertainty and related measures of treatment effect;
- any unplanned changes to the GSD and methods after trial commencement;
- characteristics and demographics of patients by treatment arm at each interim analyses (or by stage) and;
- measures to minimise potential operational biases during interim analyses and decision-making.
PANDA users should read the ACE reporting guidance on other reporting aspects that should be addressed with explanation and examples.
References
1. Dimairo et al. The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. BMJ. 2020;369:m115.
2. Dimairo et al. The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. Trials. 2020;21(1):528.
3. Stevely et al. An investigation of the shortcomings of the CONSORT 2010 Statement for the reporting of group sequential randomised controlled trials: A methodological systematic review. PLoS One. 2015;10(11):e0141104.
2. Dimairo et al. The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. Trials. 2020;21(1):528.
3. Stevely et al. An investigation of the shortcomings of the CONSORT 2010 Statement for the reporting of group sequential randomised controlled trials: A methodological systematic review. PLoS One. 2015;10(11):e0141104.