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.
Unlock Commercial Growth through Data-Driven Patient and HCP Insights
May 2nd 2025Leveraging data-driven patient and healthcare provider (HCP) insights, including social drivers of health (SDOH), is essential for life sciences companies to continuously improve patient engagement and commercial success. Mark Rodgers, AVP of Commercial Analytics at Inovalon, discusses how identifying treatment milestones, assessing HCP performance, and segmenting patient populations using SDOH data can drive targeted strategies that improve healthcare outcomes and market access
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.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
