Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|October 30, 2014
EMA Provides Rapid Feedback on GSK Ebola Vaccine
European Medicines Agency has given 'rapid scientific advice'
Advertisement
For the first time in the current Ebola outbreak, the European Medicines Agency (EMA) has given ‘rapid scientific advice’ using an accelerated procedure to GSK on its development plan for an Ebola vaccine.
Through rapid scientific advice, developers can receive EMA’s expert opinion and advice on topics such as clinical trial design, manufacturing-related questions as well as safety monitoring of medicines. EMA established this procedure to contribute to the global response against Ebola and to help companies speed up the development of vaccines and treatments.
EMA hopes this procedure will help companies to generate the robust data and information needed to assess that treatments and vaccines against Ebola actually work, are acceptably safe and of high quality. It says it will assess any data in a ‘rolling review’, as soon as they become available.
The initial review and any subsequent updates will be shared with healthcare decision-makers in countries affected by the current Ebola outbreak. This will help them to take informed decisions on whether and how they want to use vaccines and medicines in their specific situation.
Read the full release
Advertisement
Related to this article
Clinical trials capture data faster than ever, but the real bottleneck is the distance between data capture and a decision teams can trust.
In today’s ACT Brief, we examine why the future of AI in trials is a trusted orchestration system rather than a single model, how coordinators rate eSource-enabled workflows, and what a bipartisan bill proposes for reusable trial networks.
The Faster Clinical Trials Act would create an FDA Center for Clinical Trial Innovation and aims to cut trial costs and enrollment time by at least 30%.
Standardized measurement across five oncology centers found that clinical research coordinators rated eSource-enabled workflows positively (Overall Mean Satisfaction 5.79 of 7), with reduced manual entry and electronic data transfer earning strong marks, while perceived reduction in sponsor and monitor queries lagged as the one domain below threshold.
In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, describes the industry’s trajectory toward a unified intelligence orchestration environment—and explains why the future isn’t one model that knows everything, but a trusted system that brings the right evidence to the right human decision.
In today’s ACT Brief, we examine how sites can avoid both fear-driven and overly aggressive AI adoption, why community-based research needs sustained financial investment, and why patient access matters more than organizational size.
Pacing obesity trial enrollment, anchoring eligibility to stable real-world therapies, and building site and physician relationships improve retention and data quality more than aggressive recruitment or restrictive exclusion criteria do.
Advertisement
Advertisement
Trending on Applied Clinical Trials Online
1
Clinical Trials Do Not Have a Data Problem, They Have a Decision-Readiness Problem
2
Where the Industry Is Headed as Clinical, Operational, and Real-World Data Connect
3
ACT Brief: Orchestrated AI Clinical Environments, eSource Coordinator Satisfaction, and Faster Clinical Trials Act
4
Building Standardized Evidence for eSource-Enabled Clinical Trials: Multi-Site Validation of a Clinical Research Coordinator Satisfaction Methodology
5