1 Upcoming events with contributions of the working group

  • DIA webinar: Estimands How and Why - A Real Life Case Study in Oncology
    • Date and Time: Sep 28th 2021, 10am - 11:30am EST
    • Registration
    • Background: The talk was previously presented in the European region (as part of a PSI webinar, slides and recording) and received overwhelmingly positive feedback which motivated us to repeat this webinar and professional development opportunity in collaboration with the DIA Statistics and Data Science Community. This time the webinar will include an extended 30 Minutes panel discussion.
    • Panelists: Lei Nie and Donna Przepiorka from FDA, Catherine Njue from Health Canada and Frank Bretz from Novartis.
    • Description of the webinar: The aim of estimand framework (the ICH E9 R1 guidance) is to increase the dialogue between functional areas working on proper alignment of trial objectives formulation, design, conduct, statistical analyses, and conclusions. This webinar is an opportunity to learn about the estimand framework. You will be guided through a case study (CheckMate 037) and interactively deepen the knowledge to gain hands-on experience in developing estimands. You will be introduced to the background and disease context of the case study, the concept of an estimand, and important clinical events that occurred in the trial and potentially affected interpretation of the results. Using non-technical language and clear graphical presentation of the concepts, you will experience how the estimand framework provides a common language to describe the diversity of patient journeys and why it is important to address the right question in clinical trials. The targeted learning outcomes are to 1) recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of clinical trial setting, in order to have a common language to describe the diversity of patient journeys and address the right question in clinical trials; 2) be able to construct an estimand, including identification of relevant intercurrent events and application of relevant strategies to address them; and 3) gain insights from a cross-industry international working group on estimands in oncology.
    • Target audience: Clinicians, Investigators, Regulatory Experts, Medical Writers, Ethics Committees, and Statisticians. No need to have prior knowledge in oncology or of estimands.

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

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2019-03-18 Munich Germany Contributed talks

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Link to Program

2019-05-29: LIDS 2019

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

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Link to Program

2019-06-02: PSI annual conference 2019

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2019-06-02 London UK Contributed talks

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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

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2019-07-14 Leuven Belgium Contributed talk

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Rui Tang: Estimands in the Presence of Treatment Switching

2019-07-27: Joint Statistical Meetings 2019

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2019-07-27 Denver USA Topic contributed session

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Link to Program

2019-09-23: EFSPI Regulatory Statistics Workshop 2019

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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

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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

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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: Discussant (no slides)

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?

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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: Discussant (no slides)
Kunthel By: Discussant FDA (no slides)
Catherine Njue: Discussant from Health Canada (no slides)
Richard J. Cook: Discussant (no slides)

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

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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

2021-08-08: Joint Statistical Meetings 2021

Start City Country Type
2021-08-08 Virtual USA Topic contributed session

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Link to Program

2021-09-21: ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop 2021

Start City Country Type
2021-09-21 Virtual USA Invited talks and panel discussion

Program

Link to Program

Talks and/or recording

Speaker (click on title to download slides)
Devan Mehrotra: Estimands and Sensitivity Analyses in Clinical Trials - Strengthening Alignment with ICH E9 (R1)
Kaspar Rufibach: Session organizer

2021-09-21: ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop 2021

Start City Country Type
2021-09-21 Virtual USA Contributed topic session

Program

Link to Program

2021-09-21: ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop 2021

Start City Country Type
2021-09-21 Virtual USA Contributed topic session

Program

Link to Program