SESSION J

TITLE: Answering Old Questions with New Tools: Application of the ICH E9 Addendum in Oncology
SPEAKERS: Kaspar Rufibach, Roche and Evgeny Degtyarev, Novartis
MODERATOR:Kalyan Ghosh

Abstract:

This shortcourse will discuss the application of the ICH E9(R1) estimand addendum to oncology clinical trials. Using examples we will illustrate how the estimand framework supports transparent formulation of clinical trial objective(s) for challenging drug development questions such as

  • treatment switching,
  • complexity of treatment options and existence of potential curative procedures or treatment sequence across different phases in hematological trials,
  • the use of a principal stratum estimand to assess the impact of post-randomization events such as development of antidrug antibodies on efficacy or safety of a new drug.

Often, such type of questions are answered using simplified analyses that are only valid under strong assumptions. To make these assumptions transparent we will discuss estimands, estimation methods, impact on data collection, and experiences with Health Authorities for these scenarios. Finally, we will share our experience in implementing the addendum in large pharmaceutical companies, within biostatistics and for other partner functions.

More on the oncology estimand WG: http://www.oncoestimand.org

 

Instructor’s Bio:

Kaspar Rufibach is an Expert Statistical Scientist in Roche’s Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry, regulatory agencies, and the academic community in various working groups and collaborations. He has co-founded and co-leads the European special interest group “Estimands in oncology” (sponsored by PSI and EFSPI, which also has the status as an ASA scientific working group, a subsection of the ASA biopharmaceutical section) that currently has 38 members representing 22 companies and several Health Authorities and works on various topics around estimands in oncology. Kaspar’s research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands and causal inference, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.

More on the oncology estimand WG: https://oncoestimand.github.io/home/oncoestimand.html

More on Kaspar: https://www.kasparrufibach.ch 

Evgeny Degtyarev is Global Program Biostatistics Head leading a team of quantitative scientists on CAR-T program in hematology at Novartis. Before joining Novartis in Basel in 2013, Evgeny studied mathematics and economics at the University of Magdeburg in Germany. Since then he has supported several oncology programs with targeted and immunotherapies in different stages of development.

He has co-founded and co-leads the industry working group “Estimands in oncology” in Feb 2018 which has been later granted the status of EFSPI/PSI Special Interest Group and ASA Biopharmaceutical Section Scientific Working Group (www.oncoestimand.org).

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