1 Upcoming events with contributions of the working group

  • ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop 2021
    • Clinical and Statistical Perspectives on Post-ICH E9 (R1) Addendum Estimand Use: Current Status and Future Directions. Organizers: Kaspar Rufibach (Roche), Lei Nie (FDA), Shanti Gomatam (FDA). Frank Bretz (Novartis), Alexei Ionan (FDA). Presenters and panel discussion: Devan Mehrotra (Merck, ICH E9 (R1) Expert Working Group member, statistical), Sally Seymour (FDA, Division Director, clinical), David Lebwohl (Intellia Therapeutics, clinical), John Scott (FDA, CBER, statistical), Bohdana Ratitch (Bayer, statistical), Sylva Collins (FDA, CDER, statistical).
    • Estimands in Oncology: White Papers from an Industry Working Group. Organizer: Jonathan Siegel (Bayer). Presenters: Natalia Kan-Dobrosky (PPDI), Jonathan Siegel (Bayer), Satrajit Roychoudhury (Pfizer). Discussant: Qing Xu (FDA).
  • Joint Statistical Meetings 2021

2 Past events and and all presentation slide decks

2019-02-15: HTA EFSPI SIG 1-day event

Start City Country Type
2019-02-15 Berlin Germany Invited talk

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Evgeny Degtyarev: Estimands in Oncology

2019-03-18: DAGStat 2019

Start City Country Type
2019-03-18 Munich Germany Contributed talks

Program

Link to Program

2019-05-29: LIDS 2019

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2019-05-29 Pittsburgh USA Contributed talks including EMA discussant

Program

Link to Program

2019-06-02: PSI annual conference 2019

Start City Country Type
2019-06-02 London UK Contributed talks

Program

Link to Program

2019-06-23: DIA Annual meeting 2019

Start City Country Type
2019-06-23 San Diego USA Contributed talk

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Yi Liu: Estimand Framework and its Impact on Oncology Drug Development: Findings From An Industry Wide Working Group

2019-07-14: ISCB 2019

Start City Country Type
2019-07-14 Leuven Belgium Contributed talk

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Rui Tang: Estimands in the Presence of Treatment Switching

2019-07-27: Joint Statistical Meetings 2019

Start City Country Type
2019-07-27 Denver USA Topic contributed session

Program

Link to Program

2019-09-23: EFSPI Regulatory Statistics Workshop 2019

Start City Country Type
2019-09-23 Basel Switzerland Invited talk

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Evgeny Degtyarev: Estimand framework: opportunity to rethink some old (and new) problems in Oncology trials?

2019-09-23: ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop 2019

Start City Country Type
2019-09-23 Washington USA Contributed talks (including FDA discussant)

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Feng Liu: Causal Estimand and Principal Stratum, an Overview and Potential Applications in Oncology
Jiangxiu Zhou: Estimands for PFS2
Alexei C. Ionan (FDA discussant): Estimand Framework in Oncology Drug Development: Challenges and Opportunities

2019-09-27: ESMO 2019

Start City Country Type
2019-09-27 Barcelona Spain Poster

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Daniel George: Impact of estimand selection on adjuvant treatment outcomes in renal cell carcinoma (RCC)
Bryant Furlow: Commentary on poster

2019-10-20: ISOQoL 2019

Start City Country Type
2019-10-20 San Diego USA Contributed talk

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Rachael Lawrance: Using PROs in clinical trials: what should I know about?

2020-05-06: Webinar of the Basel Biometrics Section: Impact of COVID-19 on clinical trials

Start City Country Type
2020-05-06 Webinar Switzerland Invited talk

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Evgeny Degtyarev: Short overview on COVID-19 from the Cross-Industry Oncology Estimands Working Group

2020-05-21: Estimands in Oncology Virtual Panel Discussion (organized by Cytel)

Start City Country Type
2020-05-21 Webinar USA Invited talk and panelist

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Kaspar Rufibach: Estimands in oncology
Michelle Casey: NA

2020-06-11: PSI Conference Webinar: Impact of COVID-19 to estimands

Start City Country Type
2020-06-11 Webinar UK Invited talk and panelist

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Kaspar Rufibach: Application of the estimand framework to assess the impact of COVID-19 on clinical trials

2020-06-29: Webinar of the Basel Biometrics Section: Estimands addendum is final: Anything new for oncology?

Start City Country Type
2020-06-29 Webinar Switzerland Invited talk

Program

Link to Program

2020-08-01: Joint Statistical Meetings 2020

Start City Country Type
2020-08-01 Philadelphia USA Topic contributed session

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Jonathan Siegel: Estimand Framework and Its Impact on Drug Development in Oncology
Anja Schiel: NA
Kunthel By: NA
Catherine Njue: NA
Richard J. Cook: NA

2020-09-07: Webinar of the Basel Biometrics Section: RCTs meeting causal inference: principal stratum strategy and beyond

Start City Country Type
2020-09-07 Webinar Switzerland Invited talk

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Kaspar Rufibach: Introduction
Bjoern Bornkamp: Principal Stratum Strategy: Potential Role in Drug Development

2020-09-22: ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop 2020

Start City Country Type
2020-09-22 Virtual USA Invited talk

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Jonathan Siegel: Industry Perspective on Subsequent Therapy: An Estimands Approach

2020-11-05: Joint PSI, EFSPI & ASA BIOP Webinar: Estimands

Start City Country Type
2020-11-05 Virtual UK / USA Invited talk

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Evgeny Degtyarev: Estimand framework: What are the opportunities in oncology?

2020-11-17: The effective statistician podcast: A deep dive into principal stratification and causal inference

Start City Country Type
2020-11-17 Podcast Switzerland Discussion

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Kaspar Rufibach: Link to podcast
Bjoern Bornkamp: Link to podcast

2020-11-27: Working group “Pharmaceutical Industry” of the German Region of the IBS (APF)

Start City Country Type
2020-11-27 Virtual Germany Invited talk

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Hannes Buchner: Estimands update: Summary of world-wide authority interaction
Kaspar Rufibach: Estimands update: Summary of world-wide authority interaction

2020-12-09: The 76th Annual Deming Conference on Applied Statistics

Start City Country Type
2020-12-09 Virtual USA Shortcourse

Program

Link to Program

2021-02-11: ASA - FDA - LUNGevity symposium: Statistical considerations in Oncology clinical trials in the COVID-19 era

Start City Country Type
2021-02-11 Virtual USA Symposium

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Evgeny Degtyarev: How can the estimand framework support decentralized trials?
Kaspar Rufibach: How can the estimand framework support decentralized trials?

2021-04-21: Duke Industry Statistics Symposium

Start City Country Type
2021-04-21 Virtual USA Invited talk

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Natalia Kan-Dobrosky: Estimands in clinical trials with treatment switching