Ongoing non industry sponsored COVID 19 clinical trials in the first trimester of the pandemic: significant differences between the European and the USA approaches
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.
Expert review of clinical pharmacology