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EU Regulators Urged To Address Impact Of Decentralized Trials On Data Quality & Integrity

 
• By Vibha Sharma

The pharmaceutical industry has identified a range of statistical considerations relating to decentralized clinical trials that they want EU regulators to address to ensure data generated from such studies are acceptable for regulatory filings.

Healthcare business graph data and growth, Insurance Healthcare. Doctor analyzing medical of business report and medical examination with network connection on laptop screen.
Pharma needs assurance on the acceptability of data from decentralized clinical trials • Source: Shutterstock

Drug companies are urging EU regulators to update their recommendation paper on decentralized clinical trials (DCTs) with advice on how to systematically evaluate the possible impact of decentralized elements on data quality and integrity.

The recommendation paper was issued in December 2022 to present the harmonized position of EU regulators on DCTs, which allow...

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