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%.
|Articles|October 2, 2017
EFGCP Gives Priority to ‘Two Ends of Life’
Author(s)Philip Ward
Advertisement
The two ends of life can be viewed separately, but they have many common elements like frailty or vulnerability, and these shared aspects mean that geriatric and pediatric drug development should be viewed together, according to the European Forum for GCP (EFGCP).
This philosophy has inspired the Children’s Medicines and Geriatric Medicines Working Parties of the EFGCP to organize a joint meeting, called “Multi-Stakeholder Workshop on Facilitating Medicines Development for Youth and the ‘Young at Heart’: Learning for Intergenerational Strategies,” to be held in London on 21 November.
“The development of drugs is evolving and much effort is being put into understanding in special populations like children and older people,” noted a statement from the organizers. “The agenda reflects important topics like the special ethical considerations that can affect the informed consent process, evaluation of the safety parameters which is dependent of the adequate reporting of adverse events, and interpretation of the adverse drug reactions and proper use of modelling of simulation to bring value to the drug development process.”
The objective is to share challenges, to detect possible synergies, and to learn from each other to improve and facilitate high quality ethical clinical research and drug development for these populations across Europe, they added.
For more details about the event,
Advertisement
Related to this article
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.
In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, argues that CROs must act as orchestrators rather than aggregators—and that the real test of any AI ecosystem is whether it reduces sponsor coordination burden or just hands it back to them.
Syneos Health and Optum outline a joint model for trial planning, recruitment and site access, with no financial terms or timelines disclosed.
AstraZeneca and Oracle Outline AI Collaboration for Clinical Trial Recruitment and Safety Monitoring
What sponsors and sites should know about the AstraZeneca-Oracle AI collaboration on trial recruitment, safety monitoring and data governance.
Advertisement
Advertisement
Trending on Applied Clinical Trials Online
1
Where the Industry Is Headed as Clinical, Operational, and Real-World Data Connect
2
Where AI Governance in Clinical Development Falls Short
3
Building Standardized Evidence for eSource-Enabled Clinical Trials: Multi-Site Validation of a Clinical Research Coordinator Satisfaction Methodology
4
Syneos Health, Optum Partner on Adaptive Clinical Development Model
5