Call To Pool Research Resources into Large Trials to Generate Evidence On COVID-19 Treatments
EMA’s Human Medicines Committee has published a statement urging the EU research community to prioritize large randomized controlled studies because they are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments of COVID-19. The statement promotes a harmonized approach to data collection for COVID-19 clinical trials across the EU.
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Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.
