Professor Guido Rasi’s last day as Executive Director of EMA comes in the middle of one of the biggest public health emergencies of the past century. “We are seeing an unprecedented effort…to tackle the pandemic. The number of therapeutics and vaccines that are currently under development is encouraging, and information on the initial results from clinical trials on vaccines is starting to be reported by the pharmaceutical industry. In the words of one developer, ‘we are a significant step closer’ to a vaccine.”
He emphasized the importance of the role that regulators would be playing in reviewing the available data packages. “EMA will ensure that the scientific review is conducted as rapidly as possible. This is a vitally important step as the time spent in conducting the review will not only ensure that our stringent regulatory standards are met but will also serve to reinforce public confidence in the vaccines.”
His successor, Emer Cooke, he describes as, “a strong leader who is committed to steering EMA during this very challenging period and ensuring that the Agency’s work on COVID-19-related activities continues uninterrupted.” And that What is needed now is, “a reinforcement of EMA’s resources so that it can continue to deliver on its core business, deliver on the joint EMA/Heads of Medicines Agencies strategy…to address future challenges and undertake the additional activities to fulfil its new mandate.”
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
The Rise of Predictive Engagement Tools in Clinical Trials
November 22nd 2024Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.