Anja Schiel

Works at the Norwegian Medicines Agency and is one of the vice chairs of UNETA 21's Joint Scientific Consultation Committee. She focuses on bridging the gap between regulation and HTA, and communicating complex statistical problems to non-statisticians.

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Sep 15, 2025 • 46min

Top 8: The Single Arm Studies and What are the Alternatives?

Anja Schiel, a vice chair at UNETA 21 and expert at the Norwegian Medicines Agency, delves into the complexities of single-arm studies in drug approval. She discusses the critical need for robust comparisons in evidence evaluation and the limitations of single-arm designs. Anja also highlights the importance of concurrent controls and shares practical strategies for choosing effective comparators. With insights into adaptive trial designs, she sheds light on statistical communication between regulators and HTA bodies, emphasizing the need for clear evidence strategies.

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