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

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...
Multiple Comparison Tests01:13

Multiple Comparison Tests

Multiple comparison test, abbreviated as MCT, is a post hoc analysis generally performed after comparing multiple samples with one or more tests. An MCT will help identify a significantly different sample among multiple samples or a factor among multiple factors.
It would be easy to compare two samples using a significance alpha level of 0.05. In other words, there is only one sample pair to be compared. However, it would be difficult to identify a significantly different sample if the number...
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...
Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
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.

You might also read

Related Articles

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

Sort by
Same author

Advancing Theranostics in Alzheimer Disease: FDA Approval of Amyloid-β PET Drugs for Selection of Patients for Amyloid-β-Directed Therapies and Other Labeling Updates.

Journal of nuclear medicine : official publication, Society of Nuclear Medicine·2026
Same author

Gastrointestinal Acute Radiation Syndrome: Mechanisms, Models, Markers, and Medical Countermeasures.

Radiation research·2024
Same author

Quantitative Brain Amyloid PET.

Journal of nuclear medicine : official publication, Society of Nuclear Medicine·2024
Same author

The impact of misclassification errors on the performance of biomarkers based on next-generation sequencing, a simulation study.

Journal of biopharmaceutical statistics·2023
Same author

US FDA public meeting: identification of concepts and terminology for multicomponent biomarkers.

Biomarkers in medicine·2023
Same author

Bayesian Sample Size Planning Tool for Phase I Dose-Finding Trials.

JCO precision oncology·2022
Same journal

Ensuring Quality in Preclinical Research: The Importance of Being Human.

Biometrical journal. Biometrische Zeitschrift·2026
Same journal

Addressing Cluster-Level Treatment Effect Heterogeneity in Sample Size Determination for Hierarchical 2 × 2 Factorial Designs.

Biometrical journal. Biometrische Zeitschrift·2026
Same journal

A Multiple Imputation Approach to Distinguish Curative From Life-Prolonging Effects in the Presence of Missing Covariates.

Biometrical journal. Biometrische Zeitschrift·2026
Same journal

Tests for Categorical Data Beyond Pearson: A Distance Covariance and Energy Distance Approach.

Biometrical journal. Biometrische Zeitschrift·2026
Same journal

Nonparametric Estimation of the Patient-Weighted While-Alive Estimand.

Biometrical journal. Biometrische Zeitschrift·2026
Same journal

Two-Stage Multiple Test Procedures Controlling False Discovery Rate With Auxiliary Variable and Their Application to Set4 <math><semantics><mi>Δ</mi> <annotation>$\Delta$</annotation></semantics></math> Mutant Data.

Biometrical journal. Biometrische Zeitschrift·2026
See all related articles

Related Experiment Video

Updated: Jun 11, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Challenges to multiple testing in clinical trials.

H M James Hung1, Sue-Jane Wang

  • 1OB/OTS/CDER, US FDA, Silver Spring, MD 20993-0002, USA. hsienming.hung@fda.hhs.gov

Biometrical Journal. Biometrische Zeitschrift
|July 1, 2010
PubMed
Summary
This summary is machine-generated.

Clinical trials require careful statistical analysis for regulatory approval. This study emphasizes selecting appropriate multiple testing procedures that balance type I error control with clinical relevance and statistical power.

More Related Videos

Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry
05:53

Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry

Published on: June 21, 2018

Related Experiment Videos

Last Updated: Jun 11, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry
05:53

Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry

Published on: June 21, 2018

Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Regulatory Science

Background:

  • Multiple testing is a significant challenge in clinical trial statistical analysis.
  • Current practices often prioritize type I error control over clinical relevance.
  • Confusion exists in defining appropriate hypothesis families for error rate control.

Purpose of the Study:

  • To highlight the complexities of multiple testing in clinical trials.
  • To advocate for a more nuanced approach to selecting multiple comparison procedures.
  • To emphasize the importance of aligning statistical methods with clinical decision-making.

Main Methods:

  • Review of common multiple comparison procedures in regulatory settings.
  • Discussion of various types of multiple testing problems encountered.
  • Framework for selecting procedures based on study objectives and decision trees.

Main Results:

  • Overemphasis on type I error control can lead to overlooking clinical sense.
  • A wide array of multiple testing scenarios exist, requiring tailored approaches.
  • Procedure selection should precede power evaluation for optimal results.

Conclusions:

  • Selecting multiple testing procedures must consider study-specific questions and clinical context.
  • Statistical power evaluation is crucial for refining the chosen procedure.
  • A balanced approach ensures both statistical validity and clinical utility in trial evaluations.