Table 3.

Summary of analysis considerations.

Review of planned analyses	Review all planned main and sensitivity analyses to ensure alignment with the revised estimand(s). Review/amend methods for handling of missing data, or censoring rules, to accommodate pandemic-related missingness.
Summaries of pandemic impact	Summarize the occurrence of pandemic-related ICEs and protocol deviations. Summarize the number of missed or unusable assessments for all key endpoints. Summarize the number of assessments performed using alternative modalities. Summarize study population characteristics before and after pandemic onset.
Additional sensitivity and supportive analyses	Plan additional analyses for sensitivity to pandemic-related missingness. Consider the need for additional, alternative summary measures of treatment effect. Consider exploring inclusion of additional auxiliary variables, interaction effects, and time-varying exogenous covariates in the analysis methods. Consider subgroup analyses based on subgroups defined by pandemic impact, for example, primary endpoint visits before or after pandemic onset. Consider the need for evaluation of potential impact of alternative data collection modalities. Consider sources of data external to the trial, for example, to justify use of alternative modalities. Plan for additional safety analyses.