NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)

Published by NIH

Small Business Innovation ResearchRare diseasesClinical Trials

The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies.

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

Published by Nature Communications

virtual patientsIn silicoClinical Trials

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

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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.

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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

MedicinesPaediatricsClinical Trials

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.

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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.

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