Related Experiment Videos
The clinical significance of statistical significance
1Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993-0002, USA. Robert.kane@fda.hhs.gov
Abstract:
Modern clinical trials provide the evidence for most therapeutic advances, and that evidence, expressed in a statistical format, is used to draw inferences about a population from the study's results. Clinician judgment translates these inferences for best individual patient care, but many clinicians struggle with the statistical interpretation of trial results. This review provides a clinical and non-Bayesian perspective on some key elements in the statistical design, analysis, and interpretation of randomized, comparative, phase III clinical trials intended to demonstrate a better outcome (superiority) than with a control treatment.
Related Concept Videos
Statistical Significance
Significance Testing: Overview
Statistical Hypothesis Testing
Statistical significance measures the probability that an observed result occurred by chance. If this probability, known as...
Critical Region, Critical Values and Significance Level
In hypothesis testing, a sample statistic is converted to a test statistic using z, t, or chi-square distribution. A critical region is an area under the curve in probability distributions demarcated by the critical value. When the test statistic falls in this region, it suggests that the null hypothesis must be rejected. As this region contains all those values of the test...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
P-value
P-value stands for the probability value. P-value is the probability that, if the null hypothesis is true, the results from another randomly selected sample will be as extreme or more extreme as the results obtained from the given sample.
A large P-value calculated from the data indicates to not reject the null hypothesis. But a higher P-value does not mean that the null hypothesis is true. The smaller the P-value, the more unlikely...