Clinical trial research on COVID-19 in Germany - a systematic analysis

Abstract

Background: In 2020, the COVID-19 pandemic led to an unprecedented volume of almost 3,000 clinical trials registered worldwide. We aimed to describe the COVID-19 clinical trial research agenda in Germany during the first year of the pandemic. Methods: We identified randomized clinical trials assessing interventions to treat or prevent COVID-19 that were registered in 2020 and recruited or planned to recruit participants in Germany. We requested recruitment information from trial investigators as of April 2021. Results: In 2020, 65 trials were completely (n=27) or partially (n=38) conducted in Germany. Most trials investigated interventions to treat COVID-19 (86.2%; 56/65), in hospitalized patients (67.7%; 44/65), with industry funding (53.8%; 35/65). Few trials were completed (21.5%; 14/65). Overall, 187,179 participants were planned to be recruited (20,696 in Germany), with a median number of 106 German participants per trial (IQR 40 to 345). From the planned German participants, 13.4% were recruited (median 15 per trial (IQR 0 to 44). Conclusions: The overall German contribution to the worldwide COVID-19 clinical trial research agenda was modest. Few trials delivered urgently needed evidence. Most trials did not meet recruitment goals. Evaluation and international comparison of the challenges for conducting clinical trials in Germany is needed.

Keywords: COVID-19; Germany; Randomized clinical trials; SARS-CoV-2.

Figure 1.. Timeline, status, and actual recruitment for all 34 trials with recruitment information.

Notes: The figure illustrates the length of the trials with their start and end date of conduct, sorted by start date and colored by status (based on trial registration details or investigators’ request). The darker part of the bars illustrates the proportion of the target sample size in Germany that was actually recruited within each trial with the corresponding proportion (percentages reported next to the bar). The dashed vertical line corresponds to the timepoint of the recruitment status assessment, April 2021. Trials can be declared as “completed” with or without reaching their target sample size. “Terminated” trials end without reaching their intended goals and started recruiting but are not considered “complete”. “Withdrawn” trials will never start or recruit patients. * Trials that were partially conducted in Germany: the proportion of target sample size focus only on German participants and does not reflect the international recruitment accrual; $ End date was not available and was arbitrarily set at 1 June 2022.