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Related Concept Videos

Clinical Trials01:16

Clinical Trials

10.1K
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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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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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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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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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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Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

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Body: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...
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Related Experiment Video

Updated: Dec 16, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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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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Are randomized controlled trials being conducted with the right justification?

Corbin Walters1, Trevor Torgerson1, Ian Fladie1

  • 1Department of Institutional Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.

Journal of Evidence-Based Medicine
|July 3, 2020
PubMed
Summary

Less than half of randomized clinical trials cite systematic reviews for justification. Requiring this evidence could reduce wasteful health research spending and improve scientific integrity.

Keywords:
evidence-based medicinemeta-analysisrandomized control trialsystematic review

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Area of Science:

  • Medical Research
  • Clinical Trials
  • Evidence-Based Medicine

Background:

  • Significant global health research spending may be wasted annually.
  • Randomized clinical trials (RCTs) heavily influence medical practice.
  • Conducting RCTs only when systematic reviews (SRs) indicate a need can combat waste.

Purpose of the Study:

  • To analyze phase III RCTs and determine if SRs were cited as justification for their initiation.
  • To assess the extent to which SRs inform the decision-making process for new clinical trials.

Main Methods:

  • Analysis of phase III RCTs published in major medical journals (NEJM, Lancet, JAMA) from 2016-2018.
  • Duplicate and independent data extraction to ensure accuracy.
  • Extraction of data on whether SRs were cited to justify conducting the trial.

Main Results:

  • A total of 637 RCTs citing 728 SRs were examined.
  • Only 38.1% of RCTs cited an SR (verbatim or inferred) as justification.
  • Nearly half (49.5%) of the RCTs did not cite any SR.

Conclusions:

  • Less than half of analyzed RCTs used SRs as a basis for initiation.
  • Trialists should be mandated to present relevant SRs to ethics/review committees before starting trials.
  • Reducing research waste is an ethical and scientific imperative.