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Phase III trials are conducted to provide stronger evidence of the effectiveness and safety of a therapeutic intervention and typically form a key part of applications to regulatory authorities to grant market approval. They usually involve 500-3000 or more patients and compare the therapeutic intervention with the current standard of care for patients with the disease intended to be treated.
In this randomized, placebo-controlled phase 3 clinical trial, the authors assess efficacy, immunogenicity, and safety of the inactivated SARS-CoV-2 vaccine CoronaVac in children and adolescents aged 6 months to 17 years. The study was carried out in Chile, South Africa, Malaysia, and the Philippines, and coincided with the emergence of the Omicron variant.
AstraZeneca has introduced digital health solutions into clinical trials, demonstrating improved patient experience, accelerated timelines and reduced costs.
In a phase III trial, the oral Janus kinase inhibitor baricitinib was safe and effective in patients with juvenile idiopathic arthritis who previously had an inadequate response to DMARD therapy.
The IL-17A–IL-17F inhibitor bimekizumab is safe and effective for the treatment of both radiographic and non-radiographic axial spondyloarthritis, according to the results of two parallel phase III trials.