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Related Concept Videos

Clinical Trials01:16

Clinical Trials

10.0K
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...
10.0K
Clinical Trials: Overview01:11

Clinical Trials: Overview

4.2K
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...
4.2K
Blinding01:11

Blinding

3.7K
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.
3.7K
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

60
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
60
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

76
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
76
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

263
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,...
263

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Related Experiment Video

Updated: Nov 15, 2025

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability
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[Decentralised clinical trials].

Zarqa Ali1, John Robert Zibert, Simon Francis Thomsen

  • 1Zarqa_ali@hotmail.com.

Ugeskrift for Laeger
|March 4, 2021
PubMed
Summary

Decentralised clinical trials leverage digital technologies to streamline research, making studies more cost-effective, faster, and participant-friendly. This approach enhances data collection and participant monitoring throughout the trial process.

Area of Science:

  • Clinical research methodology
  • Digital health technologies
  • Health informatics

Background:

  • Traditional clinical trials face challenges in cost, time, and participant accessibility.
  • Decentralised clinical trials (DCTs) offer a novel approach to overcome these limitations.
  • The integration of technology is key to modernising clinical research.

Purpose of the Study:

  • To review the benefits and applications of decentralised clinical trials.
  • To highlight how digital solutions improve trial efficiency and participant experience.
  • To summarise the impact of technology on various stages of clinical research.

Main Methods:

  • Review of existing literature and case studies on decentralised clinical trials.
  • Analysis of digital tools and health technologies used in DCTs.

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  • Examination of data collection and monitoring strategies in decentralised settings.

    • Main Results:

    • Decentralised clinical trials significantly reduce costs and timelines.
    • Digital solutions enhance participant recruitment, engagement, and retention.
    • Continuous data collection from multiple platforms improves participant monitoring and safety.

    Conclusions:

    • Decentralised clinical trials represent a paradigm shift in clinical research.
    • The adoption of digital health technologies is crucial for the success of DCTs.
    • DCTs offer a more efficient, accessible, and participant-centric model for conducting studies.