A scoping review of randomized controlled trials in the early phase of the COVID-19 pandemic: country-level research response to COVID-19 therapeutics and vaccines - PubMed
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- #Pandemic Response
- #Clinical Trials
- #COVID-19
- A scoping review analyzed 328 randomized controlled trials (RCTs) on COVID-19 therapeutics and vaccines published between November 2019 and November 2021.
- The majority of multi-country trials (97.9%) were led by high-income countries (HICs), with HICs enrolling more participants than low- and middle-income countries (LMICs).
- Intervention duplication was observed in 68.6% of therapeutic trials led by HICs and 85.8% in those led by LMICs.
- Among investigational new drug trials, 26 were led by HICs and 16 by LMICs, with HICs having a higher proportion (odds ratio 2.5).
- Platform trials were predominantly led by HICs (28 out of 29), all focusing on therapeutics.
- Decentralization approaches and alternative consent methods were used in 15.5% and 19.2% of trials, respectively.
- LMICs were under-represented in published trials during the first two years of the pandemic.
- The study highlights the need for global collaboration, improved trial design, and operational features to strengthen clinical trial infrastructure during health emergencies.