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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...
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...
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...
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...
Blind Procedures02:07

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...
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.

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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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Three methods for constructing parallel gatekeeping procedures in clinical trials.

Alex Dmitrienko1, Julia N Soulakova, Brian A Millen

  • 1Eli Lilly and Company, Indianapolis, Indiana 46285, USA, USA. dmitrienko_alex@lilly.com

Journal of Biopharmaceutical Statistics
|April 26, 2011
PubMed
Summary
This summary is machine-generated.

This review compares three parallel gatekeeping procedures for clinical trials with multiple objectives. It offers recommendations for selecting appropriate methods based on analytical and simulation findings.

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Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Statistical Methods

Background:

  • Clinical trials often involve multiple objectives that require careful statistical management.
  • Gatekeeping procedures are essential for controlling Type I error rates when testing multiple hypotheses.
  • Parallel gatekeeping procedures offer a framework for handling objectives grouped into families.

Purpose of the Study:

  • To review and compare three classes of parallel gatekeeping procedures.
  • To provide recommendations for the application of these methods in clinical trials.
  • To illustrate the procedures using practical clinical trial examples.

Main Methods:

  • Literature review of existing parallel gatekeeping procedures.
  • Analytical comparison of the three methods.
  • Simulation studies to evaluate method performance.
  • Illustration with clinical trial examples involving two families of objectives.

Main Results:

  • A detailed comparison of the strengths and weaknesses of each gatekeeping procedure.
  • Identification of scenarios where each method is most suitable.
  • General recommendations for the practical implementation of parallel gatekeeping procedures.

Conclusions:

  • The choice of parallel gatekeeping procedure depends on the specific trial objectives and family structure.
  • Both analytical and simulation approaches are valuable for method selection.
  • Effective gatekeeping is crucial for the valid interpretation of clinical trial results.