Direct-to-Patient (DTP) refers to trial models where study activities, materials, or investigational product are delivered directly to participants rather than requiring site-only visits.
DTP approaches are common in decentralized and hybrid trials and may include home delivery, remote assessments, and direct data capture. Programs must include secure consent workflows, safety monitoring plans, and controlled chain-of-custody procedures for investigational product. Oversight expectations remain the same as site-based research, including documentation and reporting requirements. Proper DTP implementation can improve access while maintaining participant protections.