Rafael Dal-Ré1. 1. Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma De Madrid , Madrid, Spain.
Abstract
BACKGROUND: The different features between non-industry-sponsored medicine trials conducted in Europe and the USA to treat COVID-19 patients registered in the first trimester of the pandemic are unknown. METHODS: A search was conducted on four databases looking for ongoing medicine randomized controlled trials (RCTs) and non-RCTs registered current through April 25, 2020. All trials assessing medicines on prophylaxis, special populations, assessing non-medicines and convalescent plasma, were excluded. Of each trial, medicines assessed, design, sample size, registration date, study start and study completion dates, and type of patients were registered. RESULTS: 106 trials were identified, 62 in Europe and 46 in the USA ─with two conducted in both regions. In Europe, 90% were on hospitalized patients, and 70% in the USA (p<0.01). Mean of the estimated time to completion were 7.8 and 13.6 (p<0.001) months for European and USA trials . Multicenter trials were more frequent in Europe (63%) than in the USA (41%) (p=0.031). Masked RCTs were more frequently run in the USA than in Europe (p<0.001). RCTs on hospitalized patients were more commonly conducted in Europe (91%) than in the USA (65%) (p<0.01). CONCLUSIONS: Features of early registered COVID-19 RCTs with medicines in Europe and America had remarkable differences.
BACKGROUND: The different features between non-industry-sponsored medicine trials conducted in Europe and the USA to treat COVID-19patients registered in the first trimester of the pandemic are unknown. METHODS: A search was conducted on four databases looking for ongoing medicine randomized controlled trials (RCTs) and non-RCTs registered current through April 25, 2020. All trials assessing medicines on prophylaxis, special populations, assessing non-medicines and convalescent plasma, were excluded. Of each trial, medicines assessed, design, sample size, registration date, study start and study completion dates, and type of patients were registered. RESULTS: 106 trials were identified, 62 in Europe and 46 in the USA ─with two conducted in both regions. In Europe, 90% were on hospitalized patients, and 70% in the USA (p<0.01). Mean of the estimated time to completion were 7.8 and 13.6 (p<0.001) months for European and USA trials . Multicenter trials were more frequent in Europe (63%) than in the USA (41%) (p=0.031). Masked RCTs were more frequently run in the USA than in Europe (p<0.001). RCTs on hospitalized patients were more commonly conducted in Europe (91%) than in the USA (65%) (p<0.01). CONCLUSIONS: Features of early registered COVID-19 RCTs with medicines in Europe and America had remarkable differences.