| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Lotte Husemoen | Novo Nordisk | (ENCORE) The ICH E9(R1) Estimands Framework in the context of Real-World Data and Observational Studies | No presentation available |
Past events with contributions from the working group
Below a list of past events with contributions of the WG, with links to slidedecks and recordings (where available).
PSI Estimand Online Training (4 Day Workshop)
Link and Details:
Overview: Experts from the Estimand Implementation Working Group (EIWG) will provide an in-depth review of the estimand framework as laid out by ICH E9(R1) addendum. Case studies will be discussed illustrating the implementation of this framework in a variety of settings and therapeutic areas, and equivalence, non-inferiority and superiority goals. Insights into the best practice for handling intercurrent events in data will be provided by the PHUSE Implementation of Estimands using Data Standards Project Team. In addition, we will engage delegates through considering how estimands might apply to their own clinical settings, interactive quizzes and break out rooms for team discussions of a case study. To get the most from this training, delegates should be prepared to switch on cameras for discussions and complete some tasks between sessions. Team discussions will be supported by EIWG tutors.
Date & Times
- Module 1 - Monday 10th March: 09:30-15:00 BST
- Module 2 - Thursday 20th March: 09:30-15:00 BST
- Module 3 - Friday 21st March: 09:30-15:00 BST
- Module 4 - Friday 28th March: 09:00-15:00 BST
01.10.2024: 2024 DSFE Annual Conference
Contribution of the working group: Poster (encore)
Nyborg / Denmark
11.09.2024: 2024 EFSPI regulatory statistics workshop
Contribution of the working group: Poster
Biozentrum Basel / Switzerland
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Stefan Englert | J&J | An Appraisal of the ICH E9(R1) Intercurrent Event Definition with Case Examples | link |
| Sue McKendrick | PPD Clinical Research Services | Considerations when Selecting Strategies for Intercurrent Events in Non-inferiority Trials | link |
| Vivian Lanius | Bayer AG | Realizing the benefits of estimands when reporting and communicating study results – some recommendations | link |
24.08.2024: 2024 ISPE Annual Conference
Contribution of the working group: Poster
Berlin / Germany
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Lotte Husemoen | Novo Nordisk | (ENCORE) The ICH E9(R1) Estimands Framework in the context of Real-World Data and Observational Studies | No presentation available |
17.06.2024: 2024 PSI Annual Conference - Panel
Contribution of the working group: Panel discussion
Amsterdam / Netherlands
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Kit Roes | Chair EMA MWP | Estimands in non-inferiority trials: challenges in implementation panel discussion - Panelist 1 | No presentation available |
| David Wright | AstraZeneca | Estimands in non-inferiority trials: challenges in implementation panel discussion - Panelist 2 | No presentation available |
| Tobias Mütze | Novartis | Estimands in non-inferiority trials: challenges in implementation panel discussion - Panelist 3 | No presentation available |
| Helle Lynggaard | Novo Nordisk | Estimands in non-inferiority trials: challenges in implementation panel discussion - Panelist 4 | No presentation available |
| Florian Lasch | EMA | Estimands in non-inferiority trials: challenges in implementation panel discussion - Panelist 5 | No presentation available |
| Khadija Rantell | MHRA | Estimands in non-inferiority trials: challenges in implementation panel discussion - Panelist 6 | No presentation available |
16.06.2024: 2024 PSI Annual Conference - Talks
Contribution of the working group: Oral presentation
Amsterdam / Netherlands
12.06.2024: 2024 NordicEpi Annual Conference
Contribution of the working group: Talk
Copenhagen / Denmark
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Lotte Husemoen | Novo Nordisk | The ICH E9(R1) Estimands Framework in the context of Real-World Data and Observational Studies | No presentation available |
14.11.2023: 2023 ISPOR Annual European conference
Contribution of the working group: Poster
Copenhagen / Denmark
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Pepa Polavieja/Antonia Morga | Novo Nordisk/Astellas | Estimands in Health Technology Assessments: methodological considerations and recommendations | No presentation available |
13.09.2023: 8th EFSPI Workshop on Regulatory Statistics 2023
Contribution of the working group: Poster
Basel / Switzerland
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Stefan Englert | J&J | How the Estimand Implementation Working Group brings together statisticians and clinicians to support the estimand journey | link |
11.06.2023: 2023 PSI Annual Conference
Contribution of the working group: Oral presentation
London / United Kingdom
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Sunita Rehal | GSK | The estimands framework in non-inferiority trials: Past, Present & Future | link |
| Pepa Polavieja/Antonia Morga | Novo Nordisk/Astellas | The ICH E9(R1) Addendum in the context of Health Technology Assessments: methodological considerations and recommendations - Speaker 3 | No presentation available |
| Paul Terrill | Ptstat.co.uk | UPDATE - Estimand Implementation Working Group (EIWG) | link |
| Helle Lynggaard | Novo Nordisk | Does it Make Sense to Apply the Estimand Framework to Clinical Pharmacology Trials? - Speaker 1 | link |
| Sue McKendrick | PPD Clinical Research Services | Does it Make Sense to Apply the Estimand Framework to Clinical Pharmacology Trials? - Speaker 2 | link |
12.06.2022: 2022 PSI Annual Conference
Contribution of the working group: Poster
Gothenburg / Sweden
21.06.2021: 2021 PSI Annual Conference
Contribution of the working group: Oral presentation
Online / Online