Oncology estimand working group: newsletter 11 October 2022

Hi all,

We hope this reaches you well! It has been a while since we last reached out to the entire group. We would like to share some recent developments, events, and achievements.

1 Updates

• On June 28th & 29th we had two full group TCs with regulators attending where we presented our work. Slidedecks are available here.
• Since the last newsletter three additional paper have been submitted (Rufibach et al., 2022, Englert et al., 2022, Mercier et al., 2022). See the publications page for details. With submission of this paper (and the work on the revision) the follow-up quantification task force has concluded its work.
• 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!
• The WG has organized two sessions at the ASA FDA workshop (“Adjusted and Unadjusted Estimate in Clinical Trials: Reward, Risk and Myth” and “Estimands in Oncology: A Topical Panel Discussion”), see events page,
• Two webinars are currently being planned:
  • 21st October: DIA webinar in China on conditional vs. marginal treatment effect. Jiajun Xu from the conditional and marginal effect task force will present, and panelists from FDA, academia and industry will discuss.
  • 2nd December: estimands for RWE, featuring speakers from FDA, EMA, NICE, academia and industry. Agenda and registration details available here.
• eunethta is currently seeking comments for their set of guidelines for a joint clinical assessment of European HTA bodies. Several of the WG’s papers were cited in EFPIA’s response to deliverable 4.5.
• The EFSPI/EFPIA Estimands Implementation WG (EIWG) has published yet another paper Principles and recommendations for incorporating estimands into clinical study protocol templates. The paper is well worth a read.

2 Action items for WG members

• PSI has reached out to us: they are currently planning the 2023 PSI conference, to be held at the Novotel London West, Hammersmith from 12 to 14 June 2023. We are invited to run a session of our WG, details (speakers, abstracts, chair) of a suggested session are due 18th November. Please get back to us in due time if you’d like to contribute to such a session, likely with results of task force work.
• Please also 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