Impact of the COVID-19 pandemic on the design, collection and analysis of clinical trial data in oncology

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Contemp Clin Trials. March 2022 21:106736. doi: 10.1016/j.cct.2022.106736. Online ahead of print.

ABSTRACT

BACKGROUND: To identify and assess by simulation the impact of the COVID-19 pandemic on oncology trials and discuss potential mitigation strategies for study design, data collection, endpoints and outcomes. analyzes.

METHODS: We simulated clinical trials to assess the impact of COVID-19 on overall survival and progression-free survival. We assessed survival in single-region trials with different proportions of patients affected in the treatment arms, and in multi-region randomized trials with different proportions of patients affected in all regions. We also assessed the impact on PFS when lack of disease assessment and censorship rules vary. The impact on the success of the trial and the robustness of statistical inference was summarized.

RESULTS: Without regional impact, the impact on OS analysis is minimal if the proportions of patients impacted are similar across arms, however, if a greater proportion of patients in the treatment arm are impacted, trials can experience substantial power loss and underestimate the size of the treatment effect. For multi-regional trials, if more patients in the treatment group are recruited from more severely affected regions, the trials also have lower performance. For PFS analysis, the intention-to-treat rule works well even when patients in the treatment group are more likely to miss disease assessments, while the consecutive absence censoring rule may result in fewer good performance.

CONCLUSION: COVID-19 affects oncology trials. The simulations would be very informative for the data monitoring committee to understand the impact and make appropriate recommendations, upon which the sponsor could begin planning potential remedies. We also recommend a decision tree for choosing appropriate PFS assessment methods in the presence of missing disease assessments due to COVID-19.

PMID:35331946 | DOI:10.1016/j.cct.2022.106736

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