Decision-Making Criteria and Methods for Initiating Late-Stage Clinical Trials in Drug Development from a Multi-Stakeholder Perspective: A Scoping Review
Event: PSI 2025, Verona, Italy Authors: Ce Jiang, Céline Beji, Sonia Zebachi, Ghinwa Y. Hayek, Aysun Cetinyurek-Yavuz, Muhammad Bergas N. Fayyad, Laura Rodwell, Kit C. B. Roes, Billy Amzal, Christoph Gerlinger, Raphaël Porcher, Julien Tanniou View Abstract The decision-making process in drug development involves “go/no-go” decisions, particularly at the transition from early to late-stages trials. While the decisions are solely made by drug developers, they must […]
Decision-Making Criteria and Methods for Initiating Late-Stage Clinical Trials in Drug Development from a Multi-Stakeholder Perspective: A Scoping Review
Publisher: Clinical Pharmacology and Therapeutics Authors: Ce Jiang, Céline Beji, Sonia Zebachi, Ghinwa Y. Hayek, Aysun Cetinyurek-Yavuz, Muhammad Bergas N. Fayyad, Laura Rodwell, Kit C. B. Roes, Billy Amzal, Christoph Gerlinger, Raphaël Porcher, Julien Tanniou View Publication The decision-making process in drug development involves “go/no-go” decisions, particularly at the transition from early to late-stages trials. […]
On the Concepts, Methods, and Use of “Probability of Success” for Drug Development Decision-Making: A Scoping Review
Publisher: Clinical Pharmacology and Therapeutics Authors: Aysun Cetinyurek Yavuz, Muhammad Bergas Nur Fayyad, Ce Jiang, Florie Brion Bouvier, Celine Beji, Sonia Zebachi, Ghinwa Y. Hayek, Billy Amzal, Raphael Porcher, Julien Tanniou, Kit Roes, Laura Rodwell View publication Abstract Drug development is a lengthy process with considerable uncertainty at each milestone. Several trials are needed to progress […]
Existing practices for the identification, selection or assessment of registries for regulatory/HTA purposes: a More-EUROPA project systematic review
Event: ISPOR Europe 2023, Copenhagen, Denmark Authors: S. Zebachi, J. Moreira, J. Tanniou, P. Godbillot, P. Tang, B. Amzal View Poster Objectives Real-world data (RWD), particularly patient registries, represent a potential useful source of information and may be required at various stages of the drug lifecycle. Different questions may be asked throughout the regulatory and/or […]
What are unmet needs in the use of registries in regulatory/HTA decision-making in Europe? A survey-based approach from the More-EUROPA project
Event: ISPOR Europe 2023, Copenhagen, Denmark Authors: J. Moreira, J. Tanniou, P. Tang, P. Godbillot, F. Ahrens, B. Amzal View Poster Objectives The More-EUROPA project, involving 14 public and private organizations from 7 EU countries, evaluates the effective and ethical use of registry data to support patient-centered decisions by drug regulators and Health Technology Assessment (HTA) agencies in Europe. Specifically, one […]
Criteria and methods applied to decision-making to embark on late-stage clinical trials with a multi-stakeholder perspective
Event: ISPOR Europe 2023, Copenhagen, Denmark Authors: C. Jiang, J. Tanniou, B. Amzal View Poster Objectives The More-EUROPA project aims at establishing the value of registry-based RWD in enhancing RCT data and enabling a more effective and ethical use of registry data to support patient-centred regulatory and HTA decision-making. Work package 1 (WP1) is specifically […]
