Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Related Concept Videos

Clinical Trials

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: Overview

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 Approaches

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...

Preclinical Development: Overview

Preclinical Development: Overview

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...

Blind Procedures

Blind Procedures

Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which child was...

Study Designs in Epidemiology

Study Designs in Epidemiology

Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and case-control studies.

You might also read

Related Articles

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

Sort by

Same author

A methodological assessment of randomization integrity in alteplase for acute ischemic stroke individual patient data meta-analyses.

PloS one·2025

Same author

The fundamentals of multiplicity adjustment in biostatistics.

Journal of the National Cancer Institute. Monographs·2025

Same author

Steady-state statistical properties and implementation of randomization designs with maximum tolerated imbalance restriction for two-arm equal allocation clinical trials.

Statistics in medicine·2024

Same author

On "Re-randomization tests as sensitivity analyses to confirm immunological noninferiority of an investigational vaccine: Case study" by Luca Grassano et al. (2023, Pharmaceutical Statistics).

Pharmaceutical statistics·2024

Same author

A roadmap to using randomization in clinical trials.

BMC medical research methodology·2021

Same author

Conditional estimation and inference to address observed covariate imbalance in randomized clinical trials.

Clinical trials (London, England)·2018

Search research articles

Related Experiment Video

Updated: Jul 11, 2026

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

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

Published on: September 20, 2019

On improving research methodology in clinical trials.

Vance W Berger¹, J Rosser Matthews, Eric N Grosch

¹National Cancer Institute, University of Maryland, Baltimore, MD, USA. vb78c@nih.gov

Statistical Methods in Medical Research

|October 11, 2007

Summary

This summary is machine-generated.

Standardized statistical analyses in biomedical research can improve rigor. This model encourages challenging default methods with evidence, promoting natural selection of superior research techniques over unnatural ones.

Related Experiment Videos

Last Updated: Jul 11, 2026

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

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

Published on: September 20, 2019

Area of Science:

Biomedical Research Methodology
Scientific Rigor
Evidence-Based Medicine

Background:

Scientifically sound research is crucial for informed medical decisions; flawed research can lead to adverse patient outcomes.
Many established research methods persist despite valid scientific reasons to question their conclusions.
The current system of research methodology selection is likened to 'unnatural selection'.

Purpose of the Study:

To highlight prevalent inappropriate research methods in biomedicine.
To propose a new research model promoting standardized statistical analyses as a default.
To advocate for a system that fosters methodological rigor and creativity, ensuring public safety.

Main Methods:

Illustrating examples of widely used, yet inappropriate, research methods.
Suggesting a research model where standardized statistical analyses are default but challengeable with evidence.
Analogizing the current system to 'unnatural selection' and proposing 'natural selection' for methodologies.

Main Results:

Identified widespread use of outdated or flawed research methodologies.
Proposed a framework for selecting research methods based on evidence and statistical rigor.
Argued for a shift towards a system that supports both innovation and methodological soundness.

Conclusions:

There is a critical need to update research methods in biomedicine.
A proposed model can enhance scientific validity and protect public health.
Implementing this system will facilitate creativity while ensuring methodological rigor.