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Current Status of Decentralized Clinical Trials

D2E Catalyst



Past pandemic, concept of decentralized clinical trials (DCT) has drawn attention but yet not replaced traditional site-based trials. Currently, they have become a durable part of mainstream clinical operations, mostly in hybrid form. Regulators now clearly recognize decentralized elements such as telehealth visits, home-health visits, local labs, and remote data collection, and the FDA has formal guidance in place for how to run trials using those methods.  
As of its current status, concept of DCT has won, but full decentralization has not. Sponsors are using decentralized components where they reduce patient burden or improve recruitment and retention, while keeping site-based procedures for activities that are harder to decentralize, such as complex exams, investigational product handling, or high-risk monitoring.  The evolving field is still constrained by several unresolved problems and recurring issues such as data quality and validation, operational complexity, cross-country regulatory variation, and digital equity.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-clinical-trials-decentralized-elements

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