The landscape of decentralized clinical trials (DCTs): focusing on the FDA and EMA guidance

Author:

Park Jiyeon1ORCID,Huh Ki Young1ORCID,Chung Woo Kyung1ORCID,Yu Kyung-Sang1ORCID

Affiliation:

1. Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Korea.

Funder

Ministry of Food and Drug Safety

Publisher

XMLink

Reference30 articles.

1. U.S. Food and Drug Administration (FDA). Decentralized clinical trials for drugs, biological products, and devices guidance for industry, investigators, and other stakeholders [Internet]. Accessed December 21, 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/decentralized-clinical-trials-drugs-biological-products-and-devices

2. Site visits in a multicenter ophthalmic clinical trial

3. Web-based trial to evaluate the efficacy and safety of tolterodine ER 4mg in participants with overactive bladder: REMOTE trial

4. Prospective Evaluation of Cancer Clinical Trial Accrual Patterns: Identifying Potential Barriers to Enrollment

5. Distance from Home to Research Center: A Barrier to In-Person Visits but Not Treatment Adherence in a Stroke Trial

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