In-silico trial of intracranial flow diverters replicates and expands insights from conventional clinical trials

Published by Nature Communications

Clinical TrialsIn silicovirtual patients

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 reduction

View 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 EC

Ethics CommitteeClinical TrialsNeonateMinorAdolescentConsentAssent 

The document provides recommendations on various ethical aspects of clinical trials performed in children from birth up to the legal age of adulthood.

View this resource Bookmark this resource

Committee for Medicinal Products for Human Use (CHMP) and Paediatric Committee (PDCO). Guideline on The Investigation of Medicinal Products In The Term And Preterm Neonate. 2009 Doc. Ref. EMEA/536810/2008.

Published by European Medicines Agency

Clinical TrialsNeonateAdverse Effects

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

Preparedness of medicines’ clinical trials in paediatrics. Recommendations by the Enpr-EMA working group on trial preparedness. EMA/56009/2019.

Published by European Medicines Agency

MedicinesClinical TrialsPaediatrics

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
prepared.

View this resource Bookmark this resource

Good clinical practice

Published by EMA

Clinical TrialsGood Clinical Practice (GCP)

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

Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic

Published by EMA

PandemyClinical Trials

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 reallocated

View this resource Bookmark this resource

Points to consider on implications of Coronavirus disease  (COVID-19) on methodological aspects of ongoing clinical  trials

Published by EMA

Clinical TrialsPandemy

This document points to consider on implications of Coronavirus disease  (COVID-19) on methodological aspects of ongoing clinical  trials

View this resource Bookmark this resource