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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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...
Clinical Trials: Overview01:11

Clinical Trials: Overview

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...
Hazard Ratio01:12

Hazard Ratio

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 evaluating a...
Therapeutic Drug Monitoring: Overview and Classification01:16

Therapeutic Drug Monitoring: Overview and Classification

Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...
Therapeutic Index01:13

Therapeutic Index

The therapeutic index of a drug is a key parameter in pharmacology that quantifies the relative safety of a drug by calculating the ratio between the dose that causes toxicity in half the population (50%) to the dose that proves to be effective for half the population (50%). It provides a spectrum of doses for a particular drug ranging from effective to potentially toxic. To illustrate, consider an anticoagulant agent like warfarin. It possesses a narrow window within its therapeutic index to...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

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,...

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In Silico Clinical Trials for Cardiovascular Disease
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In Silico Clinical Trials for Cardiovascular Disease

Published on: May 27, 2022

Thai clinical trials registry.

Wasee Tulvatana1, Kittisak Kulvichit, Bandit Thinkhamrop

  • 1Thai Clinical Trials Registry, The Medical Research Foundation, Bangkok, Thailand. waseetulvatana@gmail.com

Journal of Evidence-Based Medicine
|May 16, 2013
PubMed
Summary

The Thai Clinical Trials Registry (TCTR), established in 2009, enhances clinical research transparency and reduces publication bias in Thailand. It aims to build a collective database for local researchers, fostering collaboration and data accessibility.

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Area of Science:

  • Health Sciences
  • Clinical Research Management
  • Public Health Informatics

Background:

  • The Thai Clinical Trials Registry (TCTR) was founded in 2009 by university academics.
  • Financial support was provided by the Thailand Center of Excellence for Life Sciences.
  • Infrastructure and operational support came from the Clinical Research Collaboration Network and Medical Research Foundation.

Purpose of the Study:

  • To reduce publication bias in clinical research.
  • To promote transparency in research activities.
  • To minimize redundancy in clinical research studies.

Main Methods:

  • Establishment of a national clinical trials registry.
  • Securing financial and infrastructural support.
  • Gaining endorsement from the Ministry of Public Health of Thailand in December 2010.

Main Results:

  • The TCTR was successfully established and endorsed, creating a centralized platform.
  • Key stakeholders provided financial and operational support.
  • The registry serves as a foundation for a collective database.

Conclusions:

  • The TCTR is a vital resource for improving the quality and efficiency of clinical research in Thailand.
  • It facilitates the creation of a pooled database to support local researchers.
  • The registry contributes to greater research transparency and reduced bias.