Ethical approval for controlled human infectious model clinical trial protocols – A workshop report

• Refining the regulatory and ethics context of controlled human infection models – a stakeholder meeting report

  2026 Biologicals article Medicine Ethics in Clinical Research Open access

  0

  citations
• Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies – A stakeholder meeting report

  2025 Biologicals article Medicine Ethics in Clinical Research Open access

  7

  citations
• Regulatory workshop on challenge strain development and GMP manufacture – A stakeholder meeting report

  2024 Biologicals article Medicine Ethics in Clinical Research Open access

  6

  citations

3 results

• A Systematic Review of Human Challenge Trials, Designs, and Safety

  2022 Clinical Infectious Diseases review Medicine Ethics in Clinical Research Open access

  60

  citations
• Money-oriented risk-takers or deliberate decision-makers: a cross-sectional survey study of participants in controlled human infection trials

  2020 BMJ Open article Medicine Ethics in Clinical Research Open access

  32

  citations
• Assessment of Risks Associated With Severe Acute Respiratory Syndrome Coronavirus 2 Experimental Human Infection Studies

  2020 Clinical Infectious Diseases article Medicine SARS-CoV-2 and COVID-19 Research Open access

  19

  citations
• Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019

  2020 Biologicals article Medicine Ethics in Clinical Research

  13

  citations
• Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain

  2021 Biologicals article Medicine Biomedical Ethics and Regulation Open access

  9

  citations

5 results