Concepedia

Concept

Clinical trials

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2.6M

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160.6K

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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.

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