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Introduction to the special section: contextualizing significance testing in clinical trials

Heather Thompson-Brenner1

  • 1Center for Anxiety and Related Disorders, Boston University, 648 Beacon Street, Boston, MA 02215, USA. heatherthompsonbrenner@gmail.com

Summary

This special section reviews limitations in clinical trial data and significance testing. It offers improvements for psychotherapy research and practice.

Related Concept Videos

Significance Testing: Overview01:04

Significance Testing: Overview

Significance testing is a set of statistical methods used to test whether a claim about a parameter is valid. In analytical chemistry, significance testing is used primarily to determine whether the difference between two values comes from determinate or random errors. The effect of a particular change in the measurement protocol, analyst, or sample itself can cause a deviation from the expected result. In the case of a suspected deviation/outlier, we need to be able to confirm mathematically...
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Critical Region, Critical Values and Significance Level01:16

Critical Region, Critical Values and Significance Level

The critical region, critical value, and significance level are interdependent concepts crucial in hypothesis testing.
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...
Introduction to the Sign Test01:10

Introduction to the Sign Test

The sign test is an important tool in nonparametric statistics, offering a straightforward yet effective method for analyzing matched pairs, nominal data, or hypotheses concerning the median of a population. It transforms data points into positive or negative signs, avoiding the need for assumptions about data distribution and instead focusing on the direction of change. It is particularly valuable when data does not conform to the normal distribution requirements of many parametric tests. For...