Decentralized Clinical Trials

Decentralized clinical trials (DCTs) incorporate remote and technology-enabled approaches to reduce patient burden and expand trial access. DCT models may include remote visits, direct-to-patient shipments, and digital data capture.

Effective decentralized trial design requires careful consideration of protocol feasibility, data integrity, and regulatory expectations. Not all studies are appropriate for full decentralization, and many programs adopt hybrid approaches.

Well-designed decentralized trials can improve enrollment, retention, and data completeness when aligned with study objectives and patient populations.

Common decentralized trial components include:

• Remote and virtual study visits

• Electronic consent and data capture

• Direct-to-patient logistics

• Integration with traditional site-based activities