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Integrare RCT e RWE per un approccio manageriale efficace
Journal article   Peer reviewed

Integrare RCT e RWE per un approccio manageriale efficace

Pietro Giovanni Coletta, Giuseppe Massazza, Chiara Serpieri, Stefano Loss Robin, Lorenzo Angelone, Davide Croce and Edoardo Croce
Tecnica ospedaliera, Vol.53(6, luglio 2024), pp.6-11
2024

Abstract

Real world evidence Randomized controlled trials Privacy Clinical Trials
The use of personal data in clinical research requires a balance between respect for privacy and advancement of knowledge. Regulations, GDPR in particular, may not adequately address the unique requirements of clinical research, hindering its progress. Ethics committees have a key role in ensuring safety and ethical conduct of clinical trials, but their function should not be limited to formal oversight of drug and medical device approvals. Real world evidence can complement randomized controlled trials by providing insights into the efficacy of treatments in real-world scenarios, but it is critical to recognize its limitations, such as its retrospective nature and potential bias. To promote advances of clinical research and improve health care outcomes, the balance between safeguarding personal data and facilitating the exchange of scientific knowledge is critical.
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