Innovative designs, extrapolation, simulation methods and evidence-tools for rare diseases addressing regulatory needs 

Project Information

INVENTS

Grant agreement ID: 101136365

DOI

10.3030/101136365

EC signature date 16 November 2023

Start date 1 January 2024

End date 31 December 2028

Funded under

• Health

Total cost

€ 6 291 427,50

EU contribution

€ 6 198 302,50

Coordinated by

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France

CORDIS provides links to public deliverables and publications of HORIZON projects.

Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .

Deliverables

Documents, reports (3)

Review of existing criteria and framework of computational models for hybrid and model-based trial designs

Identification of gaps in availability and use of model validity and robustness criteria (Task 5.1)

Project communication tools incl.website

1st version of project’s website/ leaflet distributed (Task 8.2)

Review extrapolation, modelling and longitudinal data modelling

Review of commonly used methods, approaches, for longitudinal data modelling in PKPD (Task 1.1)

Publications

Peer reviewed articles (5)

In Silico Clinical Trials in Drug Development: A Systematic Review

Author(s): Bohua Chen, Lucia Chantal Schneider, Christian Röver, Emmanuelle Comets, Markus Christian Elze, Andrew Hooker, Joanna IntHout, Anne-Sophie Jannot, Daria Julkowska, Yanis Mimouni, Marina Savelieva, Nigel Stallard, Moreno Ursino, Marc Vandemeulebroecke, Sebastian Weber, Martin Posch, Sarah Zohar, Tim Friede
Published in: Therapeutic Innovation & Regulatory Science, Issue 60, 2026, ISSN 2168-4790
Publisher: Springer Science and Business Media LLC
DOI: 10.1007/S43441-025-00893-W

SY28-3 Opportunities and challenges of complex innovative trial designs

Author(s): M. Posch
Published in: Annals of Oncology, Issue 36, 2025, ISSN 0923-7534
Publisher: Elsevier BV
DOI: 10.1016/J.ANNONC.2025.08.081

Using Stochastic Simulation‐Estimation and Automated Model Development to Assess Power and Accuracy for Covariate Identification

Author(s): Ya‐Han Hsu, Bárbara Costa, Nuno Vale, Thomas P. C. Dorlo, Mats O. Karlsson
Published in: CPT: Pharmacometrics & Systems Pharmacology, Issue 15, 2026, ISSN 2163-8306
Publisher: Wiley
DOI: 10.1002/PSP4.70299

Addressing Causality and Homogeneity Assumptions in Exposure‐Response Analyses

Author(s): Mats O. Karlsson, Divya Brundavanam
Published in: Clinical Pharmacology & Therapeutics, Issue 119, 2026, ISSN 0009-9236
Publisher: Wiley
DOI: 10.1002/CPT.70132

Validating Physiologically‐Based Pharmacokinetic Models Using the Continuous Ranked Probability Score: Beyond Being Correct on Average

Author(s): Laurens Sluijterman, Marjolein van Borselen, Rick Greupink, Joanna IntHout
Published in: CPT: Pharmacometrics & Systems Pharmacology, Issue 15, 2026, ISSN 2163-8306
Publisher: Wiley
DOI: 10.1002/PSP4.70175