More than 130 years after discovering and naming of the Plasmodium parasites behind malaria, the world now has its first approved vaccine against them. Many malaria researchers have celebrated the development, but others have expressed concerns over the deployment of a vaccine that has only moderate efficacy. On 6 October,...
The process of obtaining authorization to conduct a clinical trial involves appointment of a Reporting Member State (RMS). In multinational clinical trials, at the same time as submitting the application dossier to the CTIS, a sponsor proposes one country from among MSCs for the RMS role. Depending on whether the selected MSC agrees...
The discussion about future vision of clinical trials started, from the very first day when Decentralized Clinical Trials (DCT) were mentioned as a method worth consideration for the wider implementation. The extent to which we should replace traditional clinical trials models with DCT solutions remains unsure mainly due to...
We are only days away from the entry into force of the Regulation No 536/2014 on clinical trials on medicinal products for human use, which repeals clinical trials Directive 2001/20/EC. A lot of time has passed since it was enacted in 2014, but for its application is required EU portal and database (Clinical Trials...