Clinical Trial Podcast | Conversations with Clinical Research Experts Patient Recruitment in Phase I Studies with Dr. Graham Wood
Aug 31, 2022
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Early Site Engagement Advice
- Engage phase one clinical units early to understand how inclusion/exclusion criteria and study length affect recruitment.
- Keep communication ongoing from synopsis to protocol development to avoid recruitment challenges.
Phase I Recruitment Site Strategy
- Phase I studies mostly recruit healthy participants, often at a single site to reduce variability.
- Multi-site studies occur when patient populations or study design complexity increase recruitment challenges.
Patient Inclusion in Phase I Trials
- Approximately 60% of phase one trials begin with healthy participants, including targeted oncology therapies.
- Increasingly, patients are incorporated earlier in multi-dose studies to gain preliminary proof of concept.