June 2025 HTA ESIG meeting - minutes

· June 26, 2025

Date/time

26-June-2025 13:00-14:00 CET

Agenda

  1. Admin updates
  2. Subgroup updates (10min)
  3. Planning of EFSPI regulatory workshop
  4. PSI Conference Update​
  5. Roundtable ISPOR submissions​

1. Admin updates

  • Email bounced back while sending slides ahead of the meeting. Please share any email address updates to Arthur

2. Subgroup updates

Multiplicity subteam

  • Paper for value in Health in preparation. Undergoing internal review process. Submission planned before summer

MAIC alternatives

  • White paper in preparation. Submission planned before the end of the year

HTA open source

  • White paper in preparation aiming to bring idea of HTA open source to the stats and wider HTA community
  • Plan to do a webinar next year, potentially collaborating with the R in HTA workstream

Treatment switching

Planning of EFSPI regulatory workshop

Draft program of the conference can be found here. 5 Topics are of relevance and we looking for volunteers to draft posters. The idea is to provide a high-level view on the HTA perspective for each of the topic.

Topic Volunteers
“Adaptive Clinical Trials” – what are the challenges and opportunities from an HTA perspective? Maximo Carreras
Characterizing the Effect of Treatment Using Hierarchical Composite Endpoints – Risks and Benefits of Win Statistics and Beyond in the HTA context Anders, Shahrul
Target trial emulation and incorporation of observational data into clinical trials from an HTA perspective Min-Hua, Orlando
From Trials to Target Populations: Extending and Extrapolating Evidence for HTA Decision-Making Ash Bullement, Peter Pemberton-Ross, Grammati, Orlando
The Added Value of Bayesian Methods for Pivotal Clinical Trials - Just a Communication Issue? – HTA perspective  
  • At least one volunteer needed for “Adaptive Clinical Trials”, at least 2 for “The Added Value of Bayesian Methods for Pivotal Clinical Trials”. For anyone interested to contribute, feel free to reach directly existing members and/or reach out any of Katrin/Lara/Arthur.
  • Target timelines is mid-August for final draft to allow enough time for company internal review process