Work

Decentralized Clinical Trials in the Development of Drugs and Biological Products

Year: 2024

Type: article

Abstract: Decentralized clinical trials (DCTs) are trials where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. FDA supports decentralization to improve participation in clinical trials. While there are benefits of DCTs, including convenience for participants, sponsors and investigators should be aware of potential challenges such as coordination of trial activities at locations other than traditional trial sites and supervision of delegated trial-activities performed remotely. Appropriate training, oversight, and up-front risk assessment and management will be key to implementing a DCT successfully.

Source: Therapeutic Innovation & Regulatory Science

DOI: 10.1007/s43441-023-00612-3

Authors: Ryan Robinson, Leonard Sacks

Institutions: United States Food and Drug Administration, Center for Drug Evaluation and Research

Language: English

Topic: Ethics in Clinical Research

Subfield: Public Health, Environmental and Occupational Health

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $3,890