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Related Concept Videos

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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Clinical Trials01:16

Clinical Trials

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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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Preclinical Development: Overview01:28

Preclinical Development: Overview

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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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Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
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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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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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Updated: Jul 15, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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Deprioritization of Ongoing Clinical Trials.

Barbara E Bierer1, Deborah A Zarin2, Luke Gelinas3

  • 1Faculty director of the Multi-Regional Clinical Trials Center of the Brigham and Women's Hospital and Harvard, a senior physician at Brigham and Women's Hospital, and a professor of medicine at Harvard Medical School.

Ethics & Human Research
|October 1, 2023
PubMed
Summary

Ensuring clinical trials remain valuable after initiation is crucial. This study examines the ethical challenges and proposes a framework for maintaining scientific relevance, especially highlighted by the COVID-19 pandemic.

Keywords:
clinical trialsdata monitoring committee (DMC)institutional review board (IRB)internal validityresearch ethicsrisk-benefit balancescientific value

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Area of Science:

  • Clinical research ethics
  • Evidence-based medicine
  • Health policy

Background:

  • Ethical clinical trials require a favorable risk-benefit balance at initiation.
  • Study value can decrease mid-trial due to external evidence shifts.
  • The COVID-19 pandemic revealed critical gaps in monitoring trial relevance.

Purpose of the Study:

  • To identify and describe the challenges of maintaining clinical trial relevance and value post-initiation.
  • To explore the ethical dynamics surrounding studies that lose expected value.
  • To propose a provisional framework for addressing these issues.

Main Methods:

  • Literature review on clinical trial ethics and value.
  • Analysis of the ethical considerations in ongoing studies.
  • Case study examination, referencing the COVID-19 pandemic context.
  • Development of a provisional framework for ongoing trial assessment.

Main Results:

  • Situations where trial value diminishes mid-study are under-addressed.
  • Significant material and human capital costs are associated with uninformative studies.
  • Ethical dilemmas arise when trials persist despite declining relevance.
  • A framework is proposed to guide the assessment of continued trial value.

Conclusions:

  • Ensuring ongoing scientific relevance and value in clinical trials is an ethical imperative.
  • The COVID-19 pandemic underscored the need for adaptive trial monitoring.
  • Further empirical research is needed to validate proposed solutions.
  • A structured approach is necessary to navigate ethical challenges of declining trial value.