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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Decentralised clinical trials of investigational medicinal products
Abdel Douiri1, Mohammad Alhnan2, Muhammad Rizwan Asghar3
1School of Population Health and Environmental Sciences, King's College London, London, UK.
Abstract:
Decentralised clinical trials (DCTs) can gather objective data in real-world settings through digital health technologies (DHTs) to obtain real-time measurements of clinical outcomes. However, such measurements remain infrequent in clinical trials of investigational medicinal products (CTIMPs). We review the decentralisation of CTIMPs, identify barriers to passive, real-time DHT use and recommend four solutions: a swift regulatory approval process for DHTs in clinical trials; development of specialised DHTs for CTIMPs; integration of human factors into DHT design for CTIMPs; and the adoption of data collection and transmission standards to enable decentralised CTIMPs to function effectively in patient homes.
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