Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Preclinical Development: Overview01:28

Preclinical Development: Overview

6.4K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
6.4K
Drug Regulation01:25

Drug Regulation

3.3K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
3.3K
Clinical Trials: Overview01:11

Clinical Trials: Overview

5.4K
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...
5.4K
Clinical Trials01:16

Clinical Trials

11.2K
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...
11.2K
In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

534
In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
534
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

551
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,...
551

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Comparing Objective and Subjective Bayes Factors for the Two-Sample Comparison: The Classification Theorem in Action.

The American statistician·2019
Same author

Teaching Principal Components Using Correlations.

Multivariate behavioral research·2017
Same author

Kurtosis as Peakedness, 1905 - 2014. <i>R.I.P.</i>

The American statistician·2015
Same author

Multiplicity and replicability: two sides of the same coin.

Pharmaceutical statistics·2014
Same author

Analysis and correction of crosstalk effects in pathway analysis.

Genome research·2013
Same author

On using the bootstrap for multiple comparisons.

Journal of biopharmaceutical statistics·2011
Same journal

An Adaptive Biomarker-based Umbrella Trial Design Using Bayesian Latent Class Model.

Statistics in biopharmaceutical research·2026
Same journal

A Bayesian Adaptive Marker-Stratified Design for Phase II Clinical Trials Using Calibrated Spike-and-Slab priors.

Statistics in biopharmaceutical research·2026
Same journal

On the Two-Step Hybrid Design for Augmenting Randomized Trials Using Real-World Data.

Statistics in biopharmaceutical research·2025
Same journal

Two-stage Adaptive Enrichment Designs with Survival Outcomes and Adjustment for Misclassification in Predictive Biomarkers.

Statistics in biopharmaceutical research·2025
Same journal

A novel longitudinal rank-sum test for multiple primary endpoints in clinical trials: Applications to neurodegenerative disorders.

Statistics in biopharmaceutical research·2025
Same journal

Isotonic Phase I cancer clinical trial design utilizing patient-reported outcomes.

Statistics in biopharmaceutical research·2025
See all related articles

Related Experiment Video

Updated: Apr 3, 2026

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

4.7K

Closed Testing in Pharmaceutical Research: Historical and Recent Developments.

Kevin S S Henning1, Peter H Westfall2

  • 1Department of Economics and International Business, Sam Houston State University, Huntsville, TX 77341.

Statistics in Biopharmaceutical Research
|September 15, 2015
PubMed
Summary
This summary is machine-generated.

Closed testing procedures help control statistical error rates in pharmaceutical research. Minimum p-value tests are more powerful than additive combination tests within closed testing frameworks.

Keywords:
Clinical TrialsClosure-based multiple testingP-Value Combination TestsPowerSimulation

More Related Videos

Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices
07:43

Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices

Published on: July 14, 2023

3.0K
An Automated Culture System for Use in Preclinical Testing of Host-Directed Therapies for Tuberculosis
09:34

An Automated Culture System for Use in Preclinical Testing of Host-Directed Therapies for Tuberculosis

Published on: August 16, 2021

2.4K

Related Experiment Videos

Last Updated: Apr 3, 2026

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

4.7K
Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices
07:43

Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices

Published on: July 14, 2023

3.0K
An Automated Culture System for Use in Preclinical Testing of Host-Directed Therapies for Tuberculosis
09:34

An Automated Culture System for Use in Preclinical Testing of Host-Directed Therapies for Tuberculosis

Published on: August 16, 2021

2.4K

Area of Science:

  • Pharmaceutical Research
  • Biostatistics
  • Clinical Trials

Background:

  • Multiple statistical inferences are common in pharmaceutical research, increasing the risk of erroneous significance findings without adjustments.
  • Closed testing procedures offer a flexible method for controlling overall error rates, widely adopted in pharmaceutical research and clinical trials.

Purpose of the Study:

  • To review the applications, benefits, and drawbacks of multiple testing and closed testing procedures in pharmaceutical research.
  • To technically examine additive-combination-based and minimum-based p-value statistics within closed testing.
  • To compare the power of these statistical approaches for composite hypotheses and multiple comparisons.

Main Methods:

  • Review of multiple testing and closed testing procedures in pharmaceutical research.
  • Technical examination of additive combination and minimum p-value statistics.
  • Mathematical proof of power differences under closed testing.

Main Results:

  • Additive combination tests are generally superior to minimum p-value tests for composite hypotheses.
  • For multiple comparisons using closed testing, minimum p-value tests outperform additive combination tests.
  • Additive combination tests can suffer significant power loss in closed testing due to "hurdles".

Conclusions:

  • Minimum p-value tests demonstrate superior power in closed testing for multiple comparisons compared to additive combination tests.
  • The power of closure-based minimum p-value tests can approach 1, while additive combination tests can approach 0.
  • These findings have significant implications for pharmaceutical researchers designing statistical analysis plans for clinical trials.