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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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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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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.
3.8K
Therapeutic Drug Monitoring: Affecting Factors01:29

Therapeutic Drug Monitoring: Affecting Factors

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Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
131
Preclinical Development: Overview01:28

Preclinical Development: Overview

5.7K
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...
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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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Identifying and responding to trial implementation challenges during multisite clinical trials.

Tracy L Greer1, Robrina Walker1, Chad D Rethorst1

  • 1Center for Depression Research and Clinical Care, Peter O'Donnell Jr. Brain Institute, The University of Texas Southwestern Medical Center, Dallas, TX 75390-9119, USA.

Journal of Substance Abuse Treatment
|March 30, 2020
PubMed
Summary
This summary is machine-generated.

The National Drug Abuse Treatment Clinical Trials Network (CTN) trial implementation faced challenges in infrastructure, participants, intervention, and study design. Lessons learned from this study can inform future research in broader healthcare settings.

Keywords:
AdherenceMultisite trial optimizationRecruitmentRetentionStudy managementTrial implementation

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Area of Science:

  • Clinical Trials
  • Implementation Science
  • Substance Use Disorder Treatment

Background:

  • The National Drug Abuse Treatment Clinical Trials Network (CTN) was established to bridge the gap between addiction treatment discovery and implementation.
  • The CTN strategically expanded in 2010 to include research in general medical settings beyond specialty addiction treatment.

Purpose of the Study:

  • To document implementation challenges and solutions for an early-phase CTN behavioral intervention study (CTN-0037 STRIDE).
  • To provide actionable insights for future study teams by categorizing and addressing implementation obstacles.

Main Methods:

  • The study details the implementation of the STimulant Reduction Intervention using Dosed Exercise (STRIDE) trial.
  • Challenges were categorized into four areas: study team infrastructure, participant/site factors, intervention specifics, and longitudinal design.

Main Results:

  • Identified implementation challenges across study team infrastructure, participant/site level, intervention delivery, and study design.
  • Developed and discussed solutions to manage these identified problems.

Conclusions:

  • Effective study management requires flexible, collaborative solutions to overcome implementation obstacles.
  • Lessons from 20 years of CTN studies, combined with implementation science, are crucial for successful adoption of interventions in diverse settings.