In-silico trials rely on virtual populations and interventions simulated using patient-specific model and may offer a solution to lower these costs. In this article, It is presented the flow diverter performance assessment (FD-PASS) in-silico trial, which model the treatment of intracranial aneurysms in 164 virtual patients with 82 distinct anatomies with a flow-diverting stent, using computational fluid dynamics to quantify post-treatment flow reductionView this resource Bookmark this resource
Ethical considerations for clinical trials on medicinal products conducted with minors. Recommendations of the expert group on clinical trials for the implementation of 12 Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (2017).
Published by European Commission (EC)Ethics CommitteeClinical TrialsNeonateMinorAdolescentConsentAssent
This guideline addresses the considerations and requirements for the design and conduct of clinical trials in premature and term neonates using medicinal products of relevance for the use by this population. It includes background information on the maturation of organs and of body functions.View this resource Bookmark this resource
This document focuses on preparedness for individual trials. However, as a development plan would normally constitute a number of trials, it is implicit that the same elements would also be relevant for preparation of a complete plan. Trial “feasibility” is the likelihood of completing a trial in a timely manner. This document moves beyond the definition of “feasibility” to present a global determination of all aspects of a trial that need to be
The scope of this Reflection Paper is to clarify the practical application of requirements for clinical trials conducted outside of the EU/EEA and submitted in Marketing Authorisation Applications to the EMA (through the centralised procedure) or to National competent Authorities (through decentralised, mutual recognition, or national procedures) . The Paper set up practical steps to be undertaken during the provision of guidance and advice in the medicine development phase and during the evaluation of Marketing Authorisation Applications.View this resource Bookmark this resource
The guidance provides concrete information on changes and protocol deviations which may be needed in the conduct of clinical trials to deal with extraordinary situations, e.g. if trial participants need to be in self-isolation or quarantine, access to public places (including hospitals) is limited due to the risk of spreading infections, and healthcare professionals are being reallocatedView this resource Bookmark this resource