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