Managing the Impact of the War in Ukraine on Clinical Trials
In view of the disruptions caused by the Russian invasion of Ukraine, the European Commission (EC), the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) are issuing initial advice for sponsors on how to manage the conduct of clinical trials in this situation.
The ongoing war in Ukraine may require sponsors to adjust the way clinical trials are run in this region, and sponsors may need advice on how to deal with the impact of protocol deviations and other consequences of the disruptions. Certain changes and protocol deviations in the current situation are unavoidable, when for example scheduled study visits cannot take place, or arrangements need to be made to transfer trial participants who are fleeing Ukraine to other investigator sites of the same trial in the European Union (EU). Adaptations will also be needed to protect the participants’ right and safety, including the continuation of ongoing trial treatment if possible, as well as to preserve the quality of the data generated by the trials. Sponsors have asked for guidance on how to handle the situation in terms of trial records, documentation, data collection, protocol deviations, and missing data with its potential impact on methodological aspects.
Read more about this guidance from EMA here.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
