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Clinical trials
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Interim Analysis Paradigm
1963 - 1991
The period saw a consolidation of interim analyses and preplanned stopping rules as core design elements, driving more ethical and efficient trials. Researchers increasingly integrated adaptive thinking, enabling earlier decisions on efficacy or futility and reducing patient exposure and trial time. This era also emphasized controlling error rates across multiple looks and endpoints, aligning trial practice with emerging regulatory expectations. Historical Significance: Foundational innovations include group sequential designs allowing early termination, a formal framework for multiple testing across interim looks and endpoints, standardized toxicity and response criteria for oncology trials, a structured approach to attributing adverse drug reactions, and efficient two-stage designs for phase II investigations. Together these advancements unified interim decision-making with rigorous statistical control, catalyzing the modern adaptive and multi-arm trial landscape and shaping contemporary regulatory guidelines.
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Structured Trial Reporting
1992 - 1998
Trial Reporting and Generalizability
1999 - 2005
Transparent Trial Reporting
2006 - 2012
Protocol Standardization and Reporting
2013 - 2019
Platform Trial Emulation
2020 - 2024