Stakeholder Perspectives on the Design of First‐In‐Human Trials for Artificial Amnion and Placenta Technology: A Qualitative Study
This study emphasises the critical role of stakeholder involvement in safeguarding the responsible design of human AAPT trials. Defining the trial objectives including well-defined stop criteria and follow-up schemes is a key element for the human AAPT trials. Establishing consensus among stakeholders is essential, as shared recommendations will facilitate alignment of expectations and promote engagement.
Authors
- Sylvia A Obermann-Borst (ORCID: https://orcid.org/0009-0004-8886-6892)
- E. J. T. Verweij (ORCID: https://orcid.org/0000-0002-9343-9957)
- Martine C. de Vries (ORCID: https://orcid.org/0000-0002-3178-7470)
- M. Beatrijs van der Hout‐van der Jagt (ORCID: https://orcid.org/0000-0002-5805-5333)
- Marieke de Vries (ORCID: https://orcid.org/0000-0003-2845-8956)
- André Krom (ORCID: https://orcid.org/0000-0001-6524-184X)
- Peter Andriessen (ORCID: https://orcid.org/0000-0002-5159-6874)
- Angret de Boer (ORCID: https://orcid.org/0000-0002-8281-5873)
- Marijn J. Vermeulen (ORCID: https://orcid.org/0000-0001-9686-8186)
- Rosa Geurtzen (ORCID: https://orcid.org/0000-0002-5640-6160)
- Marije Hogeveen (ORCID: https://orcid.org/0000-0002-2562-7606)
- Juliette S. van Haren (ORCID: https://orcid.org/0000-0002-2878-7349)
- Rania Kalaai
Institutions
- Radboud University Nijmegen (NL)
- Leiden University Medical Center (NL)
- Radboud University Medical Center (NL)
- Duchenne Parent Project (NL)
- Amalia Kinderziekenhuis (NL)
- Máxima Medisch Centrum (NL)
- Erasmus MC - Sophia Children’s Hospital (NL)
- Eindhoven University of Technology (NL)
Publication Details
- Journal
- BJOG An International Journal of Obstetrics & Gynaecology
- Published
- 2025-04-29
- DOI
- https://doi.org/10.1111/1471-0528.18189
- Citations
- 1
- Primary Topic
- Neonatal Respiratory Health Research
- Type
- article
- Field-Weighted Citation Impact
- 1.52
Funders
- ZonMw
- European Society for Paediatric Research