Two drugs recently approved by the US Food and Drug Administration (FDA) treat disease caused by the Zaire ebolavirus, one of the three viral species …

Around 300 million people suffer from a rare disease. Figures published in Tufts CSDD Impact Reports (2019) highlight the passion within the rare disease population …

There has been a difficulty with patient recruitment if patients are homebound or reluctant to go to clinics, or if clinics allow only essential or …

We are currently facing an industrial revolution in the era of big data and artificial intelligence (AI) which affects all fields, including biomedicine. This industrial …

Today, a range of Bayesian methods or techniques are being used to drive some of the most important scientific advancements of our age, from novel …

In the EU, the new EU MDR regulation came into force in May 2017 (2017/745) and will replace the current Medical Device Directive (MDD) for …

A statistical analysis plan (SAP) is a defined outline of the planned statistical analyses for a clinical trial, including basic and advanced methods. An SAP …

The foundation of good research is built on sound ethical principles, which require a good rationale, a solid methodology and proper consideration of the important …

Many elements of decentralised clinical trials (DCTs) have long been available – including mobile devices, remote monitoring, telemedicine, and home health providers – but the …

Inflammatory bowel disease (IBD), an umbrella term for chronic intestinal disorders with two subtypes: Ulcerative colitis (UC) and Crohn’s disease (CD), the result of an …