Presentation

The 9th Early Phase Adaptive Trials Workshop will bring together researchers, biostatisticians and clinical development specialists from academia, hospitals and industry in Paris.

Over the course of two days, the workshop will present methodological advances and applications relating to early-phase adaptive clinical trials. Discussions will focus in particular on dose-finding and dose optimisation, Phase I/II trials, Bayesian methods, the integration of pharmacokinetic and pharmacodynamic data, the sharing of information across populations or data sources, and the personalisation of therapeutic decisions. Significant attention will be given to simulation studies, the practical implementation of methods, and current challenges in the development of new therapies.

The format, based on short presentations and discussions, aims to foster exchanges between methodologists and to foster new collaborations.

Programme (provisional)

Wednesday 14 October

09:15 am–09:30 am: Welcoming participants and handing out badges

09:30 am–09:45 am: Welcome address and opening remarks
Moreno Ursino, Université Paris Cité / Inserm

09:45 am–10:15 am: Bayesian model averaging for partial ordering continual reassessment methods
Luka Kovacevic et coll.

10:15 am–10:45 am: Controlled backfill in oncology dose-finding trials
Hakim-Moulay Dehbi, John O’Quigley et Alexia Iasonos

10:45 am–11:15 am: Coffee break

11:15 am–11:45 am: Generalized Phase 1-2 Designs
Peter F. Thall

11:45 am–12:15 pm: Dose-finding designs to account for patient heterogeneity in cancer clinical trials evaluating cell therapies
Evan M. Bagley et Nolan A. Wages

12:30 pm–2:00 pm: Lunch

2:30 pm–3:00 pm: U-DESPE: a Bayesian Utility-based methodology for dosing regimen optimization
Sandrine Micallef et coll.

3:00 pm–3:30 pm: From Literature to Prior: Robust Bayesian Borrowing for Early-Phase Cancer Trials
Wei Wei

3:30 pm–4:00 pm: Seamless Monotherapy-Combination Phase I Dose-Escalation Model-Based Design
Libby Daniells et coll.

4:00 pm-4:30 pm: Coffee break

4:30 pm–5:00 pm: Modern Up-and-Down designs in nonclinical fatigue-life and fatigue-strength experiments
Mauro Gasparini

5:00 pm–5:30 pm: Response-adaptive randomization and randomization-based inference for phase II dose-finding (provisional title)
Lukas Pin

Thrusday 15 October

09:15 am–09:30 am: Welcoming participants and handing out badges

09:30 am–10:00 am: Identification of subtrial-specific optimal biological dose with robust borrowing of information
Zhi Cao, Pavel Mozgunov et Haiyan Zheng

10:00 am–10:30 am: Evaluating early-stage oncology clinical trial designs in the era of Project Optimus: a scoping review
Marie-Karelle Rivière et coll.

10:30 am–11:00 am: Coffee break

11:00 am–11:30 am: Applying the Partial Order Continual Reassessment Method to High-dimensional Treatment Combinations
Weishi Chen et coll.

11:30 am–12:00 pm: Optimal dose expansion in early phase oncology trials
James Willard, Thomas Jaki et Pavel Mozgunov

12:00 pm–1:30 pm: Lunch

1:30 pm–2:00 pm: Repeated interim analyses in Bayesian and frequentist group-sequential trials (provisional title)
Clément Massonnaud

2:00 pm–2:30 pm: Personalized Bayesian Phase I/II Trial Design Incorporating In Vitro Data: Application to Organoid Data in Cystic Fibrosis
Yifan Mei et coll.

2:30 pm–3:00 pm: Pending confirmation

3:00 pm–3:15 pm: Coffee break

3:15 pm–3:45 pm: Pending confirmation

3:45 pm–4:00 pm: Conclusion and closing remarks

Organisers

• Moreno Ursino, CRCN, Inserm / Université Paris Cité
• Lucie Biard, PUPH, Université Paris Cité
• Axel Vuorinen, PhD student, Inserm

A workshop organised by Université Paris Cité and Inserm, with the support of the Paris Institute for Advanced Studies.

Practical information

Event closed to the public.