Oncology estimand working group: newsletter 18th December 2023

Hi all,

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

1 Updates

  • Since the last newsletter the following publications have been submitted:
    • Siegel et al. (2023) .
  • Since the last newsletter the following publications have been accepted or already appeared:

Adding everything up the WG has published seven publications this year (numbers 9-15 in publication list). This is an amazing achievement!

  • We keep updating 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!
  • Summer conferences: Many presentations, organized invited sessions, and panel discussions at summer conferences, see events for a wrap-up and links to materials. Thanks to everyone who organized and contributed! Details:
  • Further events:
    • Stefan and Francois contributed talks to a BBS seminar on Estimands in Early Development (ED) across Therapeutic Areas.
    • Kaspar was invited to present in an FDA / Lungevity TC within Project significant on Impact of Cross-over in the Evaluation of Overall Survival in cancer RCTs, find slides here.
    • Evgeny was invited for a plenary talk at the Nordic lymphoma meeting. It is great to see the rising interest in estimands also in the clinical community! Find slides here.
    • Stefan contributed a talk to the yearly APF workshop.
  • Future conferences:
  • As a spin-off of our WG, a few colleagues from the PRO task force submitted a proposal to EFSPI for a special interest group. We except to start this very soon under the formal EFSPI umbrella.

2 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

3 References

Lawrance, R., K. Skaltsa, A. Regnault, and L. Floden. 2023+. “Reflections on Estimands for Patient-Reported Outcomes in Cancer Clinical Trials.” Journal of Biopharmaceutical Statistics To appear. (2023+). https://doi.org/10.1080/10543406.2023.2280628.
Mercier, F., V. Homer, J. Geng, H. Zhang, S. Englert, and N. Kan-Dobrosky. 2023+. “Estimands in Oncology Early Clinical Development: Assessing the Impact of Intercurrent Events on the Dose-Toxicity Relationship.” Statistics in Biopharmaceutical Research To appear. (2023+).
Siegel, Jonathan, Hans-Jochen Weber, Stefan Englert, and Feng Liu. 2023. “Time-to-Event Estimands and Loss to Follow-up in Oncology in Light of the Estimands Framework.” https://arxiv.org/abs/2203.01781.
Weber, H. J., S. Corson, J. Li, F. Mercier, S. Roychoudhury, M. O. Sailer, S. Sun, A. Todd, and G. Yung. 2023+. “Duration of and Time to Response in Oncology Clinical Trials from the Perspective of the Estimand Framework.” Pharmaceutical Statistics To appear (2023+). https://doi.org/10.1002/pst.2340.
Wei, J., J. Xu, B. Bornkamp, R. Lin, H. Tian, D. Xi, X. Zhang, Z. Zhao, and S. Roychoudhury. 2023+. “Conditional and Unconditional Treatment Effects in Randomized Clinical Trials: Estimands, Estimation, and Interpretation.” Statistics in Biopharmaceutical Research To appear. (2023+).