Oncology estimand working group

1 Purpose

Find on this webpage information on the working group on estimands in oncology.

2 Become a member

The general spirit of the working group is inclusive. If you’d like to contribute in one or the other way, we propose you first reach out to your company’s representative(s) (if applicable) and align within your company who is best placed to contribute to which task force. After that is clarified reach out to the WG leads - contact details available here.

3 Membership in professional organizations

In November 2018, the working group was established by EFSPI as European special interest group “Estimands in oncology”, sponsored by PSI and EFSPI and in June 2019 the ASA biopharmaceutical section has granted the official status as ASA scientific working group.

4 Link to this page

Link to this page: http://www.oncoestimand.org.

5 Latest updates of this page

5.1 2022

• 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.

5.2 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.