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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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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 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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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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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
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Study Designs in Epidemiology01:20

Study Designs in Epidemiology

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Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
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Updated: Jan 13, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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Navigating Complexities In Randomized Trials: Insights From The EMERGE Trial Amidst Pandemic And Cybersecurity

Christine Newman1,2,3, Fidelma Dunne1,2,3, Alberto Alvarez-Iglesias2

  • 1College of nursing, medicine and health science, University of Galway, Galway, County Galway, Ireland.

HRB Open Research
|January 12, 2026
PubMed
Summary
This summary is machine-generated.

The Early Metformin in Gestational Diabetes (EMERGE) trial successfully navigated COVID-19 and cyberattacks by implementing flexible strategies. This ensured continued recruitment and data integrity for gestational diabetes mellitus research.

Keywords:
COVID-19; Diabetesgestational; Clinical Trials; Computer security

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Area of Science:

  • Clinical Trials
  • Public Health
  • Infectious Diseases

Background:

  • The COVID-19 pandemic significantly disrupted global clinical trial operations, causing delays and terminations.
  • The Early Metformin in Gestational Diabetes (EMERGE) trial faced unique challenges including the COVID-19 pandemic and computer network attacks (CNAs).

Purpose of the Study:

  • To outline challenges and solutions for maintaining active recruitment in a high-risk patient cohort during the COVID-19 pandemic.
  • To detail adapted techniques for recruitment, adverse event reporting, and lab reporting during two critical CNAs.
  • To present solutions from both clinical trial site and sponsor perspectives.

Main Methods:

  • Implemented telemedicine and videoconferencing to overcome remote working and staffing shortages.
  • Utilized paper-based backup systems and rigorous data integrity checks to manage system disruptions caused by CNAs.
  • Adapted diagnostic pathways and patient monitoring for gestational diabetes mellitus in response to pandemic-related restrictions.

Main Results:

  • Despite COVID-19 and two CNAs, the EMERGE trial successfully continued active recruitment and follow-up.
  • Key challenges included staff shortages, remote work transitions, and disruptions to clinical and laboratory systems.
  • Solutions involved a combination of digital tools (telemedicine) and traditional methods (paper records), alongside robust data management.

Conclusions:

  • Overcoming multifaceted challenges required rapid reorganization, teamwork, and flexibility from both trial staff and the sponsor.
  • The trial's success underscored the importance of rapid innovation, adaptability, and comprehensive protocol planning in managing unforeseen crises.
  • The integration of digital and paper-based systems proved crucial for maintaining trial continuity and data integrity.