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Glossary TermBiostatistics

Statistical Power

The probability that a statistical test will correctly reject a false null hypothesis, representing the likelihood of detecting a true treatment effect when one actually exists.

ICH Reference: ICH E9(R1) Section 3.5

Detailed Explanation

Statistical power quantifies a clinical trial's ability to identify true treatment effects, serving as a critical measure of study adequacy. A trial with 80% power has an 80% probability of demonstrating statistical significance if the true treatment effect matches assumptions used in the power calculation. Conversely, such a trial has a 20% probability of failing to detect a real effect, a Type II error. Higher power reduces the risk of false-negative conclusions but requires larger sample sizes and greater resources.

Power is determined by the interplay of several factors that can be manipulated in trial design. Larger sample sizes increase power by providing more precise estimates of treatment effects. Larger true treatment effects are easier to detect, requiring less power for the same sample size. Lower variability in outcomes improves precision and increases power. More stringent significance thresholds reduce power because they require stronger evidence to declare significance. Understanding these relationships enables investigators to design trials that balance scientific requirements against practical constraints.

Adequate power is essential for ethical trial conduct because underpowered studies may fail to detect beneficial treatments, potentially delaying or preventing patient access to effective therapies. Regulatory guidance typically recommends power of at least 80% to 90% for confirmatory trials, though the appropriate power level depends on the consequences of false-negative conclusions in the specific clinical context. Post-hoc power calculations after study completion, using observed effects rather than assumed effects, are generally discouraged as they can be misleading.

Also Known As

PowerTest PowerStatistical SensitivityDetection Power

Examples

Trial design

"The trial was designed with 90% power to detect a 20% relative risk reduction, meaning that if the treatment truly reduced risk by 20%, there was a 90% probability that the trial would demonstrate statistical significance."

Underpowered study

"The Phase II study enrolled only 60 participants and had approximately 50% power to detect the hypothesized effect, meaning that even if the treatment was effective, there was a substantial chance the study would fail to demonstrate statistical significance."

Related Terms

sample-size-calculationp-valueconfidence-intervalprimary-endpoint-secondary-endpointintent-to-treat-analysis

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