Latest updates of this page

2024

• 20th February: Our first linkedin video was published!
• 15th February: The paper on Time-to-event estimands and loss to follow-up in oncology in light of the estimands framework has been accepted by Pharmaceutical Statistics, see publications.
• 15th January: Added submitte paper Censoring Assumptions for Time-to-event Endpoints for Oncology Trials in Light of the Estimands Framework to publications.

2023

• 18th December: Latest newsletter to the group.
• 12th December: The papers on
  • Estimands in oncology early clinical development: Assessing the impact of intercurrent events on the dose-toxicity relationship.
  • Conditional and Unconditional treatment effects in randomized clinical trials: Estimands, Estimation, and Interpretation. have both been accepted by Statistics in Biopharmaceutical Research, see publications.
• 7th December: The paper on Reflections on estimands for patient-reported outcomes in cancer clinical trials. has been accepted by Journal of Biopharmaceutical Statistics, see publications.
• 5th December: Added 2023 achievements.
• 1st November: Anja Victor and Stefan Englert will present at APF Workshop in Darmstadt.
• 7th October: The paper on Duration of and time to response in oncology clinical trials from the perspective of the estimand framework. has been accepted by Pharmaceutical Statistics, see publications.
• 6th October: Added slides of panel discussion on “Estimands in Oncology: New Directions” at ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop.
• 13th September: Poster presented by the conditional vs. marginal taskforce at the 8th EFSPI regulatory statistics workshop.
• 11th September: Updated roster.
• 7th August: Added Jonathan’s JSM talk.
• 17th July: Latest newsletter to the group.
• 6th July: Added more slidedecks of LIDS conference.
• 23th June: The paper on Defining estimands for efficacy assessment in single arm Phase 1b or Phase 2 clinical trials in oncology early development. has been accepted by Pharmaceutical Statistics, see publications.
• 7th June: Added titles of talks and for some of them slidedecks of LIDS conference.
• 21th April: Added slides and recordings of BBS seminar Quantification of risk: ask the right questions or time to apply the estimand framework to safety! to past events page.
• 19th April: The paper on Logic-Respecting Efficacy Estimands has been accepted by Statistics in Biopharmaceutical Research.
• 15th March: The paper on quantification of follow-up has been accepted by Pharmaceutical Statistics.
• 30th January:
  • Updated status of task forces.
  • The group will give an invited talk around the topic of estimands at the Nordic lymphoma meeting in November.

2022

• 21th December: The duration of response has submitted a paper including code. See publications.
• 16th December: Latest newsletter to the group.
• 15th December: The WG has been granted an entire session at the 2023 PSI Conference in London, see here for the agenda.
• 3rd December: Added slidedecks and link to recording of ASA New Jersey Chapter Webinar Series: Getting the question right: Applying the Estimand and Target Trial Frameworks with External Controls to events.
• 29th November: Updated roster of Time to event endpoints with prognostic or predictive biomarker subgroups task force.
• 25th November:
  • Moved this page to quarto implying a slightly different look.
  • Added 2022 achievements.
• 16th November: Jonathan Siegel will give a presentation on estimands for time-to-event endpoints at the Duke Industry Statistics Symposium 2023 in March 2023, see events for details.
• 15th November: Together with ASA NJ chapter the WG is co-organizing a webinar, see events for details.
• 24th October: Added slides of the conditional and marginal taskforce presented at a DIA China webinar.
• 11th October: Latest newsletter to the group.
• 24th September: Added slidedecks from recent conferences.
• 1st July: Added slidedeck and written updates of recent full group TC.
• 29th June: After submission of its paper (see publications) the follow-up quantification task force is now inactive.
• 17th June: Added talks from our session at the PSI conference in Gothenburg.
• 13th June: Paper from follow-up quantification task force posted on arXiv. See publications.
• 23th May: Latest newsletter to the group.
• 17th May: updated events page with past and upcoming appearances of the WG.
• 26th March: added slidedeck and recording of Graham Dunn Seminar to events page.
• 8th March: arxiv links added for the two submitted papers of the censoring subteam.
• 4th March: We have now officially started work in the safety taskforce. Many thanks to Jonathan Siegel for starting and leading this!
• 3rd February: Congratulations to the authors of Sun et al. and Bornkamp et al. - these papers were the 3rd and 4th most downloaded papers that appeared in 2021 in Pharmaceutical Statistics.
• 26nd January: The censoring subteam has submitted two papers, see publications.

2021

• 22nd December: Added slidedeck on backfitting MMRM of PRO task force, see their entry here.
• 6th December: Latest newsletter to the group.
• 26th November: Added new page Further resources with links to other estimand working groups (we are aware of) and a section with introductory estimand material.
• 13th October: Added remit of Task Force 2.
• 30th September: Added slidedeck from recent, under events.
• 22th September: Added new paper by Hampson et al. to publications.
• 17th September: Latest newsletter to the group.
• 2nd September: Added announcement of DIA webinar: Estimands How and Why - A Real Life Case Study in Oncology on events page.
• 25th July: Added a section on collaborations to the organization tab.
• 10th July: The paper on treatment switching has been accepted by Pharmaceutical statistics.
• 22th June: New design of this webpage online.
• 15th June: Added slidedeck that the clinical engagement subteam presented at the Society for Clinical Trials conference 2021.
• 7th June: Added slidedeck and recording from PSI EIWG Webinar: Estimands in Oncology - How and Why, updated team roster.
• 3rd May: Added members of EDEN task force.
• 28th April: The WG offers a new webinar PSI EIWG Webinar: Estimands in Oncology - How and Why, targeted at Clinicians, Investigators, Regulatory Experts, Medical Writers, Ethics Committees, Statisticians.
• 13th April: Kickoff of EDEN (Early Development Estimand Nexus) task force.
• 22th March: Natalia Kan-Dobrosky will talk at the Duke Industry Statistics Symposium on “Estimands in clinical trials with treatment switching”.
• 5th March: Two sessions with involvement of the WG at this year’s ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop 2021, see below for details.
• 28th February: Added rosters and objectives of task forces.
• 11th February: Added slides presented by Evgeny and Kaspar at ASA - FDA - LUNGevity symposium “Statistical considerations in Oncology clinical trials in the COVID-19 era”.
• 5th February: Papers on principal stratification and hematology case studies both accepted for publication by Pharmaceutical Statistics. See publication section.
• 30th January: Kick-off of new task forces.