The paper addresses the need to modernize regulatory frameworks for clinical trials, emphasizing that inefficiencies stem from outdated concepts rather than regulatory intent. It proposes eliminating the term ‘source,’ recognizing Trusted Third Parties, and embracing digital standards like certified copies. Additionally, it recommends a new ‘HyperTrial’ designation for technologically advanced studies and supports adaptive statistical decision-making in trials. These changes aim to enhance trial quality, reduce costs, and align regulations with current technological advancements, ensuring timely and efficient clinical research.
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