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A clinical trial involves the study of the safety, efficacy and/or dosage regimen of a therapeutic intervention (such as a drug) in humans selected according to predetermined criteria of eligibility (such as a defined severity of a specific disease), who are observed for predefined evidence of favourable and unfavourable effects.
Waning immunity and the emergence of the SARS-CoV-2 Omicron lineage led to reduced vaccine effectiveness and required vaccine updates. Here, the authors assess how different priming regimens affect the immunogenicity of BA.1 and BA.5 bivalent boosters.
An early-phase trial suggests safety and improvements in vision after treatment with the CRISPR-based therapy EDIT-101, providing proof of concept for in vivo retinal gene editing.
Final results of two studies — whose preliminary data led to regulatory approval of the gene therapy exagamglogene autotemcel — describe highly effective treatment of sickle-cell disease and transfusion-dependent β-thalassemia.
The lay summary of trial results to be provided to participants should be written in plain language, use infographics and be concise — something that currently is almost never achieved.
A randomized controlled trial involving a telemedicine-based approach for the management of patients with acute coronary syndrome had several clinical benefits relative to standard of care.
An argument framework, grounded in the sciences of reasoning, provides an alternative to medicine’s measurement framework for evaluating and synthesizing evidence in healthcare.