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Related Concept Videos

Clinical Trials01:16

Clinical Trials

7.0K
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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Clinical Trials: Overview01:11

Clinical Trials: Overview

3.1K
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...
3.1K
Preclinical Development: Overview01:28

Preclinical Development: Overview

4.6K
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...
4.6K
Teratogenicity01:07

Teratogenicity

2.6K
The ability of a drug to produce structural deformations and functional abnormalities in the developing embryo or the fetus is called teratogenicity, and the drug producing this effect is known as a teratogen. Teratogenic effects include stillbirth, miscarriage, intrauterine growth restriction, and neurocognitive delay. A teratogen may affect the embryo at different stages of development, which is important in determining the type and extent of the damage. During blastocyst formation, the early...
2.6K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

158
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,...
158
Hazard Ratio01:12

Hazard Ratio

215
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...
215

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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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Clinical trials and pregnancy.

Catriona Waitt1, Denise Astill2,3, Eleonor Zavala4

  • 1University of Liverpool, Liverpool, UK.

Communications Medicine
|October 27, 2022
PubMed
Summary
This summary is machine-generated.

Excluding pregnant individuals from clinical trials hinders the development of safe and effective treatments for all patients. Ensuring the safety of unborn babies is paramount, but this exclusion creates significant gaps in medical knowledge.

Keywords:
Reproductive biologyReproductive disordersToxicology

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Area of Science:

  • Medical Ethics
  • Clinical Research
  • Obstetrics

Background:

  • Historically, pregnant individuals have been excluded from clinical trials due to ethical concerns regarding fetal safety.
  • This exclusion poses challenges in evaluating the safety and efficacy of new medical interventions for this population.

Purpose of the Study:

  • To address the ethical considerations and practical challenges of including pregnant individuals in clinical trials.
  • To explore methodologies for ensuring the safety of both the pregnant person and the fetus during clinical research.

Main Methods:

  • Review of existing ethical guidelines and regulatory frameworks for clinical trials involving pregnant participants.
  • Analysis of historical data and case studies on the outcomes of pregnant individuals in research settings.
  • Discussion of innovative trial designs and risk mitigation strategies.

Main Results:

  • The absence of pregnant individuals in trials leads to a lack of evidence-based treatment guidelines for this demographic.
  • Ethical frameworks can be adapted to protect pregnant participants and their fetuses while enabling research participation.
  • Careful planning and monitoring are essential for safe and effective research involving pregnant populations.

Conclusions:

  • Including pregnant individuals in clinical trials is ethically imperative and scientifically necessary.
  • Robust ethical oversight and tailored research methodologies can mitigate risks and generate vital data.
  • Further research is needed to develop best practices for the inclusion of pregnant populations in clinical trials.