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PSI Launch & Lifecycle SIG Webinar: 'Do you want to stay single? Considerations on single arm trials in the post-regulatory space'

05 October 2023

Yulia Dyachkova, Nathalie Barbier, Cornelia Dunger-Baldauf on behalf of the Launch & Lifecycle eSIG.

Do you really want to stay single? Single arm trials (SAT) are not preferred but remain in use throughout the drug development cycle.  They may be accepted by regulators in oncology and in rare disease when potential effects of new treatments are very large and placebo treatment is unethical. However, in the post-regulatory space, SAT are common, and perhaps even more poorly suited to address the questions of interest. We review regulator and HTA positions on SATs, further challenges posed by SATs even in the context of evolving methods, case studies, and communication tips to influence decision making and optimize design to answer questions.

To find out a little more about our Speakers, please visit the event page for full details. And if you'd like to learn more about the Launch & Lifecycle SIG, whether to share your feedback, get involved or simply stay up to date, please visit our SIG page.

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