Oncology estimand working group: newsletter 17th July 2023

Hi all,

We hope this reaches you well! Before we all leave for summer vacation we would like to share again some recent developments, events, and achievements.

1 Updates

Since the last newsletter the following publications have been accepted or already appeared:
- Rufibach et al. (2023), including code.
- Liu et al. (2023) .
- Englert et al. (2023) .
We have updated the events page with our past and upcoming appearances, including posting of presented slidedecks. Please let us know of further presentations, workshops, webinars, etc that are not on the list yet!
Conferences: the working group contributed
- a session to the PSI 2023 conference in London. Hong Tian, Konstantina Skaltsa, Stefan Englert, Lynda Grinsted, Elizabeth Pilling, and Yufei Wang presented outcomes from various taskforces to a completely full room.
- even organized two sessions at the LIDS 2023 conference in Raleigh.
- co-organized and contributed to a BBS seminar on Quantification of risk: ask the right questions or time to apply the estimand framework to safety!.
- Jonathan gave an invited talk at the Duke industry statistics symposium 2023.

2 Upcoming events and potential meet-up

2.1 JSM in Toronto

If there is interest we are happy to organize a get together, e.g. dinner. Please reach out to Kaspar Rufibach in case you are interested and provide the nights you’d be available.

2.2 ISCB in Milan

Kaspar will participate, feel free to reach out (I will only be there Mon - Wed and very busy, but happy to catch up during coffee break).

2.3 CEN in Basel

If there is interest we are happy to organize a get together, e.g. dinner. Please reach out to Kaspar Rufibach in case you are interested and provide the nights you’d be available.

2.4 EFSPI regulatory statistics workshop

If there is interest we are happy to organize a get together, e.g. dinner. Please reach out to Kaspar Rufibach in case you are interested and provide the nights you’d be available.

2.5 ASA FDA workshop

I invite our US colleagues to also organize a get together there.

3 Action items for WG members

Please routinely share slidedecks or links to other material that we can add to the events page.

You are invited to share the link to this newsletter broadly. To conclude, we invite you to regularly check out our webpage: www.oncoestimand.org.

Kind Regards,
Evgeny & Kaspar

4 References

Englert, Stefan, François Mercier, Elizabeth A. Pilling, Victoria Homer, Christina Habermehl, Stefan Zimmermann, and Natalia Kan-Dobrosky. 2023. “Defining Estimands for Efficacy Assessment in Single Arm Phase 1b or Phase 2 Clinical Trials in Oncology Early Development.” Pharmaceutical Statistics 22 (5): 921–37. https://doi.org/https://doi.org/10.1002/pst.2319.

Liu, Yi, Miao Yang, Siyoen Kil, Jiang Li, Shoubhik Mondal, Yue Shentu, Hong Tian, Liwei Wang, and Godwin Yung. 2023. “From Logic-Respecting Efficacy Estimands to Logic-Ensuring Analysis Principle for Time-to-Event Endpoint in Randomized Clinical Trials with Subgroups.” Statistics in Biopharmaceutical Research 0 (0): 1–14. https://doi.org/10.1080/19466315.2023.2186945.

Rufibach, Kaspar, Lynda Grinsted, Jiang Li, Hans Jochen Weber, Cheng Zheng, and Jiangxiu Zhou. 2023. “Quantification of Follow-up Time in Oncology Clinical Trials with a Time-to-Event Endpoint: Asking the Right Questions.” Pharmaceutical Statistics n/a (n/a). https://doi.org/https://doi.org/10.1002/pst.2300.