Optimize Your Phase 1 Healthy Trial Design
Phase 1 clinical trial design differs significantly from later phases. With readily distinguishable objectives and research involving healthy participants, unique ethical review concerns arise. Trial designs should optimize study flexibility and subject protection, leveraging all pertinent knowledge to maximize data collection and to minimize participant risk.
This whitepaper discusses sound design of study procedures and covers some general rules on screening, recruitment, consent, and compensation activities of Phase I Healthy trials.