TL;DR
COMET is now the international standard for harmonising outcomes for harmonising outcomes for specific health conditions and has transformed patient participation in outcome-setting from 16% up to 2013 to 93% in 2020.
A comparative legal and policy analysis of the low-risk clinical trial frameworks applicable in the European Union, United Kingdom (UK), and Switzerland (CH) identifies the principal elements within the legal provisions of each jurisdiction that determine whether a clinical trial may be categorised as low-risk and exam...
When the number of patients is limited in clinical trials for rare diseases and pediatric developments, enrolling sufficient participants for confirmatory randomized clinical trials is difficult. Alternative trial designs using external controls have been proposed: augmented randomized clinical trials (ARCTs) and suppl...
BACKGROUND Evidence-based guidelines are essential to optimize healthcare decision-making, yet in contexts such as rare diseases, emerging conditions, or specific subpopulations, direct evidence to estimate the magnitude of intervention effects may be minimal or absent. In these situations, guideline panels must formul...
Reliable clinical research requires careful study design, appropriate methodology, rigorous statistical analysis, and transparent reporting. This article discusses the fundamental principles involved in designing and critically evaluating clinical studies, with particular emphasis on randomized controlled trials (RCTs)...
Clinical trials are usually analyzed using frequentist methods and interpreted through p-values, which are often poorly understood. In contrast, Bayesian analyses yield probabilistic statements that offer a more intuitive interpretation of treatment effects and uncertainty. To demonstrate the utility of pr...
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