New reporting items and recommendations for randomized trials impacted by COVID-19 and force majeure events: a targeted approach.

BACKGROUND: Appropriate analyses and reporting are essential to the reproducibility and interpretation of clinical trials. However, the coronavirus disease 19 (COVID-19) pandemic and other force majeure events, like the war in Ukraine, have impacted the conduct of clinical trials. METHODS: The number of clinical trials potentially impacted were estimated from clinicaltrials.gov. To identify reporting items considered vital for assessing the impact of COVID-19, we reviewed 35 randomized phase III trials from three top oncology journals published between July and December 2020. For validation, we reviewed 29 phase III trials published between January and December 2021. RESULTS: Our results show that the number of clinical trials being potentially impacted in cancer, cardiovascular diseases, and diabetes is at least 1,484, 535, and 145, respectively. The magnitude of disruption is most significant in oncology trials. Based on the review of 35 trials, a modified checklist with ten new and four modified items covering pandemic's impact on trial conduct, protocol changes, delays, data capture, analysis and interpretation was developed to ensure comprehensive and transparent reporting. Our validation shows that six out of seven applicable reporting items were reported in less than 21% of the articles. CONCLUSIONS: Our recommendations were proposed to improve the reporting of randomized clinical trials impacted by COVID-19 and force majeure events that are broadly applicable to different areas of medical research.

Duke Scholars

Author Herbert Pang Biostatistics & Bioinformatics, Division of Biostatistics

Author Xiaofei Wang Biostatistics & Bioinformatics, Division of Biostatistics