Do you really want to stay single? Single arm trials (SAT) are not preferred but often 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 will present the most frequently asked questions in the post-marketing space, the reasons why SATs are not able to address these questions, and how statisticians might reasonably influence decision makers to consider alternatives.
This session is applicable to statisticians working in any phase of research who want to learn more about influencing decision making regarding SATs. Attendees will learn more about past, current and future uses of SATs; the contexts in which SATs will and will not meet objectives; and how to influence decision makers to consider alternatives. This session will be highly interactive and questions and feedback are absolutely welcome!
Who is this event intended for? Statisticians working in any phase of research who want to learn more about influencing the conduct of single arm trials.
What is the benefit of attending? Attendees will have the chance to learn more about influencing non-statistical stakeholders to choose designs and data sources that will best address their questions. As the host SIG, we will also utilise this as an opportunity to get critical feedback from attendees which will help to shape ideas for an upcoming manuscript.
11:00-12:00 BST | 12:00-13:00 CEST
Associate Director Biostatistician of Merck
Yulia Dyachkova is a highly experienced biostatistician with over 25 years in the pharmaceutical industry across multiple therapeutic areas (neuroscience, cardiovascular, pulmonary, and most extensively oncology). Passionate about working with cross-functional teams and helping non-statisticians understand statistical concepts, she has made significant contributions in the medical affairs area. Yulia has led all aspects of statistical launch activities in a broad variety of global markets including responsibility in HTA, RWE, generating and interpreting real world evidence, designing phase IV studies. She has been involved as author/co-author of many manuscripts published in medical and statistical peer review journals. Currently, Yulia works at Merck as an Associate Director Biostatistician. Yulia holds a Master degree in Biostatistics, from University of British Columbia, Vancouver.
Global Group Head in Global Medical Affairs and Access Biostatistics at Novartis
Nathalie Barbier is an experienced leader of statisticians with more than 30 years’ experience in the pharmaceutical industry. She has a broad range of experience in successful drug development projects, from pre-clinical research to post submission profiling and health economics within different therapeutic areas. She is currently Global group Head in Global Medical Affairs and Access Biostatistics at Novartis Pharma Basel.
Cornelia Dunger-Baldauf has more than 30 years of experience in the pharmaceutical industry as a lead statistician in roles with increasing levels of responsibility. When overseeing all development phases of a Therapeutic Area, her responsibility included RWE evaluation. RWE became one of her research topics. She joined the Statistical Methodology Group at Novartis 3 years ago to lead a team working on a project which combines evidence from RCTs and clinical practice.