Do You Want to Stay Single? Considerations on Single-Arm Trials in Drug Development
A Talk by Yulia Dyachkova , Nathalie Barbier and Cornelia Dunger-Baldauf
About this Talk
Our recent manuscript in Pharmaceutical Statistics discusses the continued use of single-arm trials (SATs) in drug development, especially in areas like oncology and rare diseases where control groups may be unethical. While sometimes accepted by regulators, SATs often fall short in addressing broader research questions, particularly post-approval. This session will cover regulatory and HTA perspectives on SATs, challenges they pose, and new statistical methods to contextualize SAT results. A medical director will share insights on community perceptions, reasons SATs may be requested, and strategies for improving decision-making and study design to meet evidence needs.
About The Speakers
Associate Director Biostatistician, Merck Healthcare
She is a highly experienced biostatistician with over 25 years in the pharmaceutical industry, specializing in multiple therapeutic areas, including neuroscience, cardiovascular, pulmonary, and most extensively, oncology.
Senior Director Biostatistics| Global Group Head Medical Affairs Immunology, Novartis
She is an experienced leader of statisticians with more than 30 years of experience in the pharmaceutical industry.
