European Joint Program Rare Diseases
Internal call for innovation project in clinical trials methodology
The Internal Call for Innovation Project in Clinical Trials Methodology in Limited Populations has been launched on December 7, 2020. The call is open to EJP RD beneficiaries and their linked third parties.
The innovation methodologies topics particularly include (but are not limited to):
- Development of a disease progression model from a natural history cohort or other observational studies.
- Development and validation of a disease specific clinically meaningful outcome with special interest in PCOMs, or composite endpoints.
- Development of a design and analysis procedure for a pharmacometric model and/or bridging study.
- Development of a randomization-based model as an alternative analysis strategy and explore the level of evidence.
- The call aims to encourage collaborations among groups of experts consisting of different stakeholders including methodological experts, clinicians, patients and industry (when relevant) who will jointly develop innovative ready-to-use methods to enhance RD clinical trial methodologies.
Date limite : A networking meeting will be held on January 25th 2021 to consolidate the collaborative networks. The foreseen call closing deadline is March 3, 2021.