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A four-step strategy for handling missing outcome data in randomised trials affected by a pandemic
Suzie Cro1, Tim P Morris2,3, Brennan C Kahan2
1Imperial Clinical Trials Unit, Imperial College London, Stadium House, 68 Wood Lane, London, UK. s.cro@imperial.ac.uk.
BMC Medical Research Methodology
|August 14, 2020
Summary
This study introduces a four-step strategy to address missing data in clinical trials during the COVID-19 pandemic, offering clear guidance for statistical analysis and ensuring robust results.
Area of Science:
- Clinical Trials Methodology
- Epidemiology
- Biostatistics
Background:
- The COVID-19 pandemic has significantly disrupted ongoing clinical trials, leading to increased missing outcome data.
- Existing international drug trial guidelines lack specific recommendations for handling pandemic-related missing data.
Purpose of the Study:
- To present a structured four-step strategy for analyzing missing outcome data in randomized trials during a pandemic.
- To address missing data arising from participant infection, treatment disruptions, and loss to follow-up.
- To consider analyses for both 'pandemic-free world' and 'world including a pandemic' scenarios.
Main Methods:
- Clarify the treatment estimand considering the pandemic's impact.
- Identify missing data relevant to the chosen estimand.
- Conduct primary analysis using plausible missing data assumptions (e.g., missing-at-random).
- Perform sensitivity analyses using alternative assumptions (e.g., missing-not-at-random) to assess result robustness.
Main Results:
- For a 'pandemic-free world' estimand, data affected by the pandemic can be treated as missing.
- For a 'world including a pandemic' estimand, all data are relevant; primary analysis may use missing-at-random assumptions incorporating pandemic indicators.
- Controlled multiple imputation is recommended for sensitivity analyses.
Conclusions:
- The COVID-19 pandemic exacerbates missing data challenges in clinical trials.
- This four-step strategy provides a framework for clear and appropriate statistical analysis of ongoing trials during health crises.
Keywords:
Controlled multiple imputationCoronavirus SARS-CoV-2Covid-19EstimandsMissing dataPandemicRandomised trialsSensitivity analysisMore Related Videos
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