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Abstract:
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In December 2019 the COVID-19 outbreak emerged and quickly spread to a declared global pandemic by the World Health Organization (WHO) in March 2020. Quarantines, travel restrictions, supply chain interruptions, and site restrictions have led to difficulties in adhering to and completing study protocols. Each Sponsor/study team has had to evaluate ongoing clinical trials for impact of COVID-19 on subject safety, treatment adherence, protocol compliance, data quality and completeness, trial power and probability of success, recruitment, retention, trial integrity and interpretation. Biostatisticians have had to re-evaluate Statistical Analysis Plans(SAP), Data Monitoring Committee reports, and increased protocol deviations and missing data for impact on primary and secondary analyses. Through this presentation, real case examples from the pandemic will be illustrated from implementing tipping point analyses, modification of sample sizes, revising estimands, and assisting with overall risk assessments based on aggregate and blinded data. Reflection will be made on whether the same "stories" of the data that we started with can be made after these mitigation factors were implemented.
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