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Related Concept Videos

Clinical Trials01:16

Clinical Trials

10.0K
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...
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Blinding01:11

Blinding

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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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Clinical Trials: Overview01:11

Clinical Trials: Overview

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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...
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Randomized Experiments01:13

Randomized Experiments

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The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
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Hazard Ratio01:12

Hazard Ratio

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The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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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,...
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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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Glossary for randomized clinical trials.

V Nagendrababu1, H F Duncan2, S J Pulikkotil3

  • 1Department of Preventive and Restorative Dentistry, College of Dental Medicine, University of Sharjah, Sharjah, UAE.

International Endodontic Journal
|October 22, 2020
PubMed
Summary
This summary is machine-generated.

This paper provides a glossary of key terms for randomized clinical trials (RCTs) to help authors improve manuscript quality. Understanding RCT terminology is crucial for accurate reporting and publication in endodontics and beyond.

Keywords:
Endodonticsglossaryrandomized clinical trials

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Area of Science:

  • Clinical Research Methodology
  • Evidence-Based Dentistry
  • Scientific Publication Standards

Background:

  • Randomized clinical trials (RCTs) represent the highest level of clinical evidence due to their unbiased design.
  • The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance RCT reporting quality.
  • Suboptimal quality of RCTs in endodontics leads to frequent manuscript rejections, necessitating improved reporting guidelines like PRIRATE 2020.

Purpose of the Study:

  • To address the critical need for clear terminology in randomized clinical trials.
  • To assist authors in designing, executing, and writing manuscripts for RCTs.
  • To present a comprehensive glossary of commonly used terms in RCTs for endodontic research.

Main Methods:

  • The study involves compiling and defining essential terminology pertinent to randomized clinical trials.
  • Focuses on terms frequently encountered in the design, execution, and reporting phases of RCTs.
  • The glossary is intended to clarify key concepts for authors submitting to endodontic journals.

Main Results:

  • Identifies a lack of clarity regarding essential terms as a primary reason for RCT manuscript rejection.
  • Highlights the importance of standardized terminology for improving the quality of RCT reporting.
  • Provides a foundational resource for authors to enhance their understanding and application of RCT concepts.

Conclusions:

  • A clear understanding and consistent use of RCT terminology are vital for improving manuscript quality and publication success.
  • The developed glossary serves as a practical tool for researchers in endodontics and other clinical fields.
  • Adherence to standardized reporting practices, including terminology, strengthens the reliability of clinical evidence.