Sub-teams
The working group operates within regional and topic sub-teams. Objectives and member rosters of these sub-teams are available below.
Regional Subteams
North America
Lead: Elena Polverejan (J&J), Patrick Darken (AstraZeneca)
Objective:
- Regional regulatory and guideline expertise
- Expansion of network and outreach
- Case study and practical application development
| Name | Company | Function | Type |
|---|---|---|---|
| Xinyu Tang | Amgen | Statistician | Full |
| Stephen Ruberg | Analytix Thinking | Statistician | Full |
| Patrick Darken | AstraZeneca | Statistician | Full |
| Jonathan Fintzi | BMS | Statistician | Full |
| Bohdana Ratitch | Bayer | Statistician | Full |
| Adrian Coles | Biogen | Statistician | Full |
| Chrissie Fletcher | GSK | Statistician | Full |
| Lisa Rodriguez | GSK | Statistician | Full |
| Catherine Njue | Health Canada | Statistician | Full |
| Elena Polverejan | J&J | Statistician | Full |
| Yongming Qu | Lilly | Statistician | Full |
| Jay Park | McMaster Univ, Canada | Statistician | Full |
| Liyi Jia | Merck | Statistician | Full |
| Bharani Dharan | Novartis | Statistician | Full |
| Jared Christensen | Pfizer | Statistician | Full |
| Brian Wiens | Rivus Pharma | Statistician | Full |
| Jiao Yang | Sanofi | Statistician | Full |
| Kevin Gan | ViiV | Statistician | Full |
China
Lead: Jiawei Wie (Novartis)
Objective:
- Contribute China-specific regulatory and clinical practice perspectives
- Develop and share practical case studies and implementation examples
- Promote cross-functional understanding and adoption of the estimand framework
- Collaborate on harmonized methodological and operational recommendations
| Name | Company | Function | Type |
|---|---|---|---|
| Chen Lu | Amgen | Statistician | Full |
| Zhiyue Huang | Astellas | Statistician | Full |
| Alice Wang | AstraZeneca | Statistician | Full |
| Wentian Guo | AstraZeneca | Statistician | Full |
| Leslie Meng | Boehringer-Ingelheim | Statistician | Full |
| Longshen Xie | Brilliant Pharmaceutical | Statistician | Full |
| Jingjun Qiu | FosunPharma | Statistician | Full |
| Cui Xiong | GSK | Statistician | Full |
| Xue Yang | J&J | Statistician | Full |
| Yuhan Huang | J&J | Statistician | Full |
| Zhiwei Jiang | KeyTech | Statistician | Full |
| Hongying Li | Lilly | Statistician | Full |
| Jiawei Wie | Novartis | Statistician | Full |
| Xiaoling Wei | Novartis | Statistician | Full |
| Yankun Gong | Pfizer | Statistician | Full |
| Xin Zhang | Pfizer | Statistician | Full |
| Jiayu Fu | Zai Lab | Statistician | Full |
| Wenting Li | dMed Biopharmaceutical Co. | Statistician | Full |
Topic Subteams
Communications
Lead: Stefan Englert (J&J)
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 | Statistician | Full |
RWE and HTA
Lead: Lotte Husemoen (Novo Nordisk), Emmanuelle Boutmy (Merck)
Objective:
- The working group will advance understanding and application of ICH E9 (R1) estimand attributes throughout the clinical development lifecycle and real-world evidence (RWE) generation, ensuring effective integration into research and development (R&D) planning, health technology assessments (HTA) including joint clinical assessments (JCA), and regulatory frameworks.
- Establish Estimands as Foundation for R&D Planning and Causal Inference:
- Assess current utilization of estimands in regulatory and HTA processes and identify improvement opportunities.
- Link Estimands to Causal Inference Framework: Emphasize that well-defined estimands articulate the causal question of interest, guiding the selection of appropriate study designs, statistical methods, and target trial emulation (TTE) approaches for decision making.
- Clarify strategic goals for RWD use in R&D: When, why, and how should RWD be incorporated to achieve robust clinical development programs?
- Address transportability and generalizability between clinical trials and RWD settings, ensuring estimands reflect realistic treatment effects across diverse populations and care settings.
- Embed estimand thinking in all phases of drug development, from early clinical planning through late-stage studies.
- Foster Scientific Dialogue and Cross-Industry Collaboration:
- Facilitate collaboration among industry stakeholders, regulators, and HTA bodies to share insights and experiences on estimands in clinical development, RWE studies, and value assessments.
- Establish standardized guidance (e.g., white paper) for applying estimands—emphasizing principles over prescriptive approaches—for uniform adoption by researchers, statisticians, and regulatory bodies.
- Encourage ongoing scientific discussions on the value and implications of estimands, causal inference, target trial emulation, and the strategic integration of RWD across the R&D lifecycle.
| Name | Company | Function | Type |
|---|---|---|---|
| Antonia Morga | Astellas | Statistician | Full |
| Matthew Knowles | Astellas | Statistician | Extended |
| Alexandra Lauer | Boehringer-Ingelheim | Statistician | Full |
| Alessandro Ghiretti | Daiichi Sankyo | Statistician | Extended |
| Ilse Van Dromme | J&J | Statistician | Extended |
| Khadija Rantell | MHRA | Statistician | Full |
| Emmanuelle Boutmy | Merck | Statistician | Extended |
| Antonio Remiro-Azocar | Novo Nordisk | Statistician | Extended |
| Pepa Polavieja | Novo Nordisk | Statistician | Full |
| Lotte Husemoen | Novo Nordisk | Statistician | Extended |
| Barbara Rosettani | Roche | Statistician | Extended |
| Tatsiana Vaitsiakhovich | Sanofi | Statistician | Extended |
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 |
| Franco Mendolia | Bayer | Statistician | Full |
| Federica Cavallo | Bayer | Medical Writing | Extended |
| Chrissie Fletcher | GSK | Statistician | Full |
| Daniel Bratton | GSK | Statistician | Full |
| 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
- Publication on estimation for continuous endpoints where an intercurrent event is handled using the composite strategy
| 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 |
| Oliver Keene | Independent | Statistician | Full |
| 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 | Fortrea | 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: Sue McKendrick (PPD)
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 |
| 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 |
|---|---|---|---|
| Armin Schueler | BfArM | Statistician | Full |
| Juan Jose Abellan Andres | EMA | Statistician | Extended |
| James Bell | Elderbrook | Statistician | Full |
| Chrissie Fletcher | GSK | Statistician | Full |
| Stefan Englert | J&J | Statistician | Full |
| Khadija Rantell | MHRA | 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 |
| Frauke Friedrichs | Bayer | Statistician | Extended |
| 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 |
Study Design
Lead: Daniel Bratton (GSK)
Objective:
- Investigate the impact of estimands on trial design.
- Develop approaches and guidance for aligning the design of a trial to its estimands.
| Name | Company | Function | Type |
|---|---|---|---|
| David Wright | AstraZeneca | Statistician | Full |
| James Bell | Elderbrook | Statistician | Full |
| Daniel Bratton | GSK | Statistician | Full |
| Paul Terrill | Independent | Statistician | Full |
| Simon Newsome | Novartis | Statistician | Extended |
| Ian White | UCL | Statistician | Full |