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Related Concept Videos

What is an Experiment?01:12

What is an Experiment?

An experiment is a planned activity carried out under controlled conditions. The purpose of an experiment is to investigate the relationship between two variables. When one variable causes change in another, we call the first variable the explanatory or independent variable. The affected variable is called the response or dependent variable. In a randomized experiment, the researcher manipulates values of the explanatory variable and measures the resulting changes in the response variable. The...
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...
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to subjects...
Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs01:15

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...

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Related Experiment Video

Updated: Jul 26, 2026

The Evoked Potential Operant Conditioning System (EPOCS): A Research Tool and an Emerging Therapy for Chronic Neuromuscular Disorders
10:08

The Evoked Potential Operant Conditioning System (EPOCS): A Research Tool and an Emerging Therapy for Chronic Neuromuscular Disorders

Published on: August 25, 2022

Three years of experience with prospective randomized effectiveness studies

A Hillis1, M H Rajab, C E Baisden

  • 1Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation, Temple, Texas, USA.

Controlled Clinical Trials
|September 19, 1998
PubMed
Summary

Developing prospective randomized effectiveness studies is feasible in multi-practice settings. This methodology allows for reliable treatment outcome assessment with long-term follow-up of comparison groups.

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Last Updated: Jul 26, 2026

The Evoked Potential Operant Conditioning System (EPOCS): A Research Tool and an Emerging Therapy for Chronic Neuromuscular Disorders
10:08

The Evoked Potential Operant Conditioning System (EPOCS): A Research Tool and an Emerging Therapy for Chronic Neuromuscular Disorders

Published on: August 25, 2022

Area of Science:

  • Health Services Research
  • Clinical Trials Methodology
  • Comparative Effectiveness Research

Background:

  • Establishing effective methodologies for prospective randomized effectiveness studies is crucial for advancing evidence-based healthcare.
  • Existing observational studies often lack long-term follow-up and direct comparison groups, limiting their reliability.

Purpose of the Study:

  • To develop and evaluate a methodology for conducting prospective randomized effectiveness studies within a multi-practice academic medical center setting.
  • To establish an operational framework, the effectiveness registry, for designing and supporting comparative practice improvement studies.

Main Methods:

  • A demonstration project was implemented across a multispecialty practice, health maintenance organization, and hospital.
  • An effectiveness registry was created to manage study design and data collection, modeled after tumor registry procedures.
  • Studies involved long-term follow-up of randomized comparison groups, with limited physician data collection and no additional tests beyond clinical care.

Main Results:

  • Fourteen trials were approved by the institutional review board (IRB) between October 1993 and April 1997.
  • Patient randomization acceptance rate was 74% (596/804), with over 800 patients enrolled in 10 studies.
  • Initial findings from two studies have been accepted for publication in major peer-reviewed journals.

Conclusions:

  • Prospective randomized effectiveness studies are feasible in multi-practice settings, offering reliable assessment of treatment outcomes.
  • The developed methodology, utilizing an effectiveness registry, supports long-term follow-up and comparison of care improvements.
  • Collaborative multi-institutional arrangements are recommended to enhance sample sizes for greater statistical power.