Trusted Resource for Clinical Trials, Protocols & Progress
In adaptive designs, certain trial elements—such as sample size, treatment arms, or allocation ratios—can be modified in response to interim results. The SAP for such a trial must:
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Without a defined approval process, SAP documents may:
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An interim analysis involves evaluating accumulated trial data before formal study completion. The goals include:
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Aligning the SAP and CSR ensures:
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Version control ensures that the correct SAP version is:
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Many SAPs fail to define populations like ITT, Per Protocol (PP), or Safety Set clearly. This leads to discrepancies in data interpretation and inconsistencies across stakeholders.
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You are testing a new antihypertensive drug expected to reduce systolic BP by 8 mmHg more than placebo. Assume:
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Effect size is a quantitative measure of the magnitude of the difference between treatment and control groups. It indicates how strong or clinically meaningful the observed effect is.
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In non-inferiority trials, the sample size must be large enough to confidently rule out differences larger than the pre-specified non-inferiority margin. This ensures the new treatment is acceptably close in efficacy to the active comparator.
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The ideal number of subjects calculated from a power analysis assumes perfect retention and compliance. However, in real trials:
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