The status quo of development of decentralized clinical trials

Xiaoliang Chen¹Mingxuan Zhao²Na Lei³Lichun Dong²Qiang Lv⁴Jiashi Sun⁵Jianchang He^6*Xianglin Zhang^1*

• ¹Shenyang Pharmaceutical University, Shenyang, China
• ²The Affiliated Anning First People's Hospital of Kunming University of Science and Technology, Kunming, China
• ³Yunnan University of Chinese Medicine, Kunming, China
• ⁴Center For Drug and Medical Device Evaluation of Yunnan Province, Kunming, China
• ⁵Center For Food and Drug Inspection of Yunnan Province, Kunming, China
• ⁶First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, Kunming, China

Decentralized clinical trials (DCTs) have emerged as a transformative model in new drug development, offering alternatives to traditional site-based trials through the integration of digital technologies and remote processes. This literature review examines the current landscape of DCTs by academic studies, policy reports, and regulatory guidance from major global regions. The review identifies and discusses the opportunities and challenges of DCTs, including scientific and operational innovation, equity and accessibility, governance and trust, sustainability and infrastructure. A comparative analysis of regulatory frameworks and guidance issued by different regulatory authorities all around the world reveals both convergences and distinctions in how DCTs are approached, particularly in areas such as digital health technologies or patient-centered model. The U.S. emphasizes efficiency and technological integration; the EU prioritizes equity and patient engagement; while China focuses on rare diseases, reducing regional disparities, and maintains a more cautious regulatory approach. The review concludes by identifying the need for greater international coordination and harmonization to fully realize the potential of DCTs while addressing their inherent risks. Building on observed regional differences, it further examines the challenges associated with harmonization, the implications of fragmented governance across jurisdictions, and the lessons learned from pilot implementations. These insights aim to inform future efforts toward more cohesive and globally aligned DCT frameworks.