Sub-teams
The working group operates within eight sub-teams. Objectives and member rosters of these sub-teams are available below.
Communications
Lead: Stefan Englert (J&J/Janssen)
Objective:
- Establish an EIWG teams site for efficient communication and collaborative working
- Homepage with working group updates and estimand resources, hosted and managed by the EIWG
- PSI session on estimand thinking and statistical leadership
| Name | Company | Function | Type |
|---|---|---|---|
| Chun-Hang Tang | Astellas | Statistician | Full |
| Stefano Vezzoli | Chiesi | Statistician | Full |
| Stefan Englert | J&J/Janssen | Statistician | Full |
HTA and RWE
Lead: Antonia Morga (Astellas), Pepa Polavieja (Novo Nordisk)
Objective:
- The late phase estimands implementation Working group brings together health economists, epidemiologists and statisticians to support the estimand journey and provide a cross-industry forum to
- Discuss estimand issues emerging in an HTA context, including HTA agencies’ awareness/adoption of Addendum and estimands framework
- Engage in scientific discussion on the value and benefits of the estimands framework in health technology assessments
- Explore the scope of estimand framework in the context of comparative effectiveness RWE studies
- Discuss issues emerging through application
- With the aim to promote broad understanding and awareness of the framework among statisticians, clinicians, health care providers, epidemiologist, health economist and health technology assessment agencies.
| Name | Company | Function | Type |
|---|---|---|---|
| Antonia Morga | Astellas | Statistician | Full |
| Frank Kleinjung | Bayer | Statistician | Extended |
| Tatsiana Vaitsiakhovich | Boehringer-Ingelheim | Statistician | NA |
| Arthur Alignol | Daichi Sankio | Statistician | NA |
| Amel Besseghir | Fresenius | Statistician | Full |
| Barbara Rosettani | Hookipapharma | Statistician | Extended |
| Khadija Rantell | MHRA | Statistician | Full |
| Emmanuelle Boutmy | Merck | Statistician | NA |
| Antonio Remiro-Azocar | Novo Nordisk | Statistician | Extended |
| Pepa Polavieja | Novo Nordisk | Statistician | Full |
| Lotte Husemoen | Novo Nordisk | Statistician | NA |
Reporting
Lead: Vivian Lanius (UCB)
Objective:
- Paper on the reporting of estimands and intercurrent events in clinical study reports, submitted in Nov 2024, published
- Continue collaboration with NIH on the reporting of estimands on “Clinicaltrials.gov”:
- Achieve agreement with NIH based on our proposals
- Provide further clarification as needed and support creation of examples
- Issue a white paper on best practices
| Name | Company | Function | Type |
|---|---|---|---|
| Barbara Glocker | Bayer | Medical Writing | Extended |
| Suvi Rajamaki | Bayer | Medical Writing | Extended |
| Federica Cavallo | Bayer | Medical Writing | Extended |
| Chrissie Fletcher | GSK | Statistician | Full |
| Daniel Bratton | GSK | Statistician | Extended |
| Melanie Wright | Novartis | Statistician | Full |
| Francesca Callegari | Novartis | Statistician | Full |
| Edith Küpper | Staburo | Disclosure Manager | Extended |
| Maarten van Dijk | Staburo | Disclosure Manager + Medical Writing | Extended |
| Gabriele Bleckert | Staburo | Statistician | Extended |
| Vivian Lanius | UCB | Statistician | Full |
| Christian Loesch | UCB | Statistician | Full |
Estimation
Lead: James Bell (Elderbrook)
Objective:
- Publication on treatment policy estimation
| Name | Company | Function | Type |
|---|---|---|---|
| David Wright | AstraZeneca | Statistician | Full |
| Marian Mitroiu | Biogen | Statistician | Extended |
| Lorenzo Guizzaro | EMA | Statistician | Full |
| James Bell | Elderbrook | Statistician | Full |
| Thomas Drury | GSK | Statistician | Extended |
| Khadija Rantell | MHRA | Statistician | Full |
| Tobias Muetze | Novartis | Statistician | Extended |
| Christian Bressen Pipper | Novo Nordisk | Statistician | Full |
| Marcel Wolbers | Roche | Statistician | Extended |
Non-inferiority
Lead: Helle Lynggaard (Novo Nordisk)
Objective:
- PSI session on estimands in non-inferiority trials
- First paper published
- Paper initiated on case studies illustrating challenges discussed in first paper
| Name | Company | Function | Type |
|---|---|---|---|
| David Wright | AstraZeneca | Statistician | Full |
| Nazanin Haseli-Mashhadi | Bayer | Statistician | Extended |
| Florian Lasch | EMA | Statistician | Extended |
| Amel Besseghir | Fresenius | Statistician | Full |
| Chrissie Fletcher | GSK | Statistician | Full |
| Sunita Rehal | GSK | Statistician | Extended |
| Oliver Keene | Independent | Statistician | Full |
| Christoph Helwig | Merck | Statistician | Extended |
| Tobias Muetze | Novartis | Statistician | Extended |
| Helle Lynggaard | Novo Nordisk | Statistician | Full |
| Chien-Ju Lin | Roche | Statistician | Extended |
| Qing Wang | Roche | Statistician | Extended |
| Claudia Hemmelmann | Sandoz | Statistician | Extended |
| Susmit Sekhar | Sandoz | Statistician | Extended |
| Vivian Lanius | UCB | Statistician | Full |
| Brennan Kahan | UCL | Statistician | Full |
Training
Lead: Judith Anzures-Cabrera (Roche)
Objective:
- To enhance understanding of the estimand framework and its practical implementation across various roles in clinical trials, including clinicians, regulators, investigators, academics, members of ethics committees, health technology assessors and statisticians.
- To utilize case studies as a means to illustrate real-world applications of the estimand framework, thereby fostering a deeper comprehension of its relevance and impact on clinical trial design, conduct, and interpretation.
| Name | Company | Function | Type |
|---|---|---|---|
| David Wright | AstraZeneca | Statistician | Full |
| Helle Lynggaard | Novo Nordisk | Statistician | Full |
| Pepa Polavieja | Novo Nordisk | Statistician | Full |
| Sue McKendrick | PPD | Statistician | Full |
| Anna Robertson | Pfizer | Statistician | Full |
| Judith Anzures-Cabrera | Roche | Statistician | Full |
Intercurrent event
Lead: Brennan Kahan (UCL)
Objective:
- Continue to identify areas of uncertainty around how the different intercurrent event strategies may be interpreted
- Identify areas of uncertainty around whether certain events meet the definition of an intercurrent event
- Identify and begin to implement appropriate strategies to reduce this uncertainty, e.g. through training materials, a possible publication, or feeding back to the ICH E9(R1) creators
| Name | Company | Function | Type |
|---|---|---|---|
| Juan Jose Abellan Andres | EMA | Statistician | Extended |
| James Bell | Elderbrook | Statistician | Full |
| Chrissie Fletcher | GSK | Statistician | Full |
| Stefan Englert | J&J/Janssen | Statistician | Full |
| Khadija Rantell | MHRA | Statistician | Full |
| Armin Schueler | Morphosys | Statistician | Full |
| Helle Lynggaard | Novo Nordisk | Statistician | Full |
| Sue McKendrick | PPD | Statistician | Full |
| Beatrice Panico | Scendea | Statistician | Full |
| Christian Loesch | UCB | Statistician | Full |
| Brennan Kahan | UCL | Statistician | Full |
Estimands in Early Phase [I/II] & Clinical Pharmacology Studies
Lead: Chun-Hang Tang (Astellas)
Objective:
- Develop a case study for implementing estimands for a dose-ranging (Ph2b) study
- Develop a case study with focus on clinical pharmacology studies in pregnant and breast-feeding women
- Input into guidance around implementing estimands for patient-reported outcomes in early phase trials
- Explore estimands for concentration modeling for PD effect (e.g., concentration-QTc).
| Name | Company | Function | Type |
|---|---|---|---|
| Chun-Hang Tang | Astellas | Statistician | Full |
| David Wright | AstraZeneca | Statistician | Full |
| Chrissie Fletcher | GSK | Statistician | Full |
| Shuying Yang | GSK | Pharmacometrician | Extended |
| Khadija Rantell | MHRA | Statistician | Full |
| Essam Kerwash | MHRA | Pharmacometrician | Extended |
| Helle Lynggaard | Novo Nordisk | Statistician | Full |
| Margrete Due Thomsen | Novo Nordisk | Statistician | Extended |
| Sue McKendrick | PPD | Statistician | Full |
| Bilyana Dabin | PPD | Statistician | Extended |
| Zara Ghodsi | Pfizer | Statistician | Full |
| Beatrice Panico | Scendea | Statistician | Full |