Superior safety in noninferiority trials

David R Bristol1

  • 1Purdue Pharma LP, Cranbury, New Jersey, USA. drbris@msn.com

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Testing a Claim about Standard Deviation01:19

Testing a Claim about Standard Deviation

A complete procedure to test a claim about population standard deviation or population variance is explained here.
The hypothesis testing for the claim of population standard deviation (or variance) requires the data and samples to be random and unbiased. The population distribution also must be normal. There is no specific requirement on the sample size as the estimation is based on the chi-square distribution.
As a first step, the hypothesis (null and alternative) concerning the claim about...
Bonferroni Test01:10

Bonferroni Test

The Bonferroni test is a statistical test named after Carlo Emilio Bonferroni, an Italian mathematician best known for Bonferroni inequalities. This statistical test is a type of multiple comparison test to determine which means are different than the rest. Bonferroni test can minimize the Type 1 error by reducing the significance level alpha, which otherwise increases with sample pairs.
The means of different samples are first paired in all possible combinations.
The null hypothesis of the...
Blinding01:11

Blinding

Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
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...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
Hazard Ratio01:12

Hazard Ratio

The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial evaluating a...