Related Experiment Video
Updated: May 28, 2026
04:53
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Implementing clinical trials on an international platform: challenges and perspectives
Greg Minisman1, Minal Bhanushali, Robin Conwit
1University of Alabama School of Public Health, Department of Biostatistics, Section on Research, Methods and Clinical Trials, RPHB 414, 1530 3rd Ave S, Birmingham AL 35294-0022, USA.
Journal of the Neurological Sciences
|November 4, 2011
Summary
International clinical trials accelerate medical research by expanding patient access and enhancing data generalizability. This global approach speeds scientific advancement, reduces disease burden, and improves worldwide health outcomes.
Area of Science:
- Clinical Research
- Translational Medicine
- Global Health
Background:
- Medical research increasingly faces pressure for rapid patient recruitment with limited resources.
- International clinical trials are encouraged by sponsors for several strategic advantages.
- Global collaboration is essential for advancing medical science efficiently.
Purpose of the Study:
- To highlight the benefits of conducting medical research on an international platform.
- To explain the reasons sponsors encourage international clinical trials.
- To underscore the impact of global research on scientific advancement and public health.
Main Methods:
- The study emphasizes the strategic advantages of multi-country patient recruitment.
- It discusses how global collaboration enhances the efficiency of clinical trials.
- The abstract focuses on the principles and benefits of international research collaboration.
Main Results:
- Conducting clinical trials in multiple countries increases access to eligible study subjects.
- International trials are completed more quickly, leading to faster scientific progress.
- Global research enhances data generalizability and improves worldwide health equity.
Conclusions:
- International clinical trials accelerate scientific discovery and reduce the burden of disease.
- Global research collaboration enhances the generalizability of findings and promotes health equity.
- Expanding clinical trials globally improves access to innovative interventions and fosters better health outcomes worldwide.
Related Concept Videos
01:11Clinical 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...
01:16Clinical 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...
There are four phases in a clinical trial. A phase one...
01:28Preclinical Development: Overview
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...
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
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, controlled...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
01:13Bioequivalence studies: Biowaivers
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...
01:15Bioavailability 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,...