Related Experiment Video
Updated: Jun 11, 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
Clinical trials profile: professionals and sites.
Helena S Paschoale1, Fernanda R Barbosa, Marcelo E Nita
1Department of Gastroenterology, University of São Paulo School of Medicine, Brazil.
Contemporary Clinical Trials
|July 6, 2010
Summary
Brazilian clinical trial professionals possess strong academic backgrounds and Good Clinical Practice (GCP) knowledge. While infrastructure is adequate, ongoing training is recommended for optimal drug development research.
Area of Science:
- Clinical research
- Drug development
- Medical infrastructure
Background:
- Clinical trials are crucial for medical breakthroughs and new drug development.
- Compliance with regulations necessitates robust infrastructure and qualified personnel.
- Evaluating the capacity of clinical trial groups in Brazil is essential.
Purpose of the Study:
- To assess professional qualifications of clinical trial investigators in Brazil.
- To evaluate site infrastructure, regulatory knowledge, and Good Clinical Practice (GCP) adherence.
- To identify areas for improvement in clinical trial conduct within Brazil.
Main Methods:
- A cross-sectional study involving Principal Investigators (PI) and Sub-Investigators (SI).
- Data collection via a questionnaire with qualitative and quantitative questions from 100 participants.
- Participant identification through Curriculum Lattes from the National Council for Scientific and Technological Development.
Main Results:
- 86% of participants hold academic degrees, with 62% holding doctorates.
- High awareness of GCP (91% for PIs, 88% for teams), but formal training is less prevalent (74% and 77%).
- Clinical trial phases conducted were predominantly II (36%), III (60%), and IV (44%), with multidisciplinary teams.
Conclusions:
- Brazilian clinical trial researchers demonstrate suitable skills and knowledge for study execution.
- Adequate infrastructure and trained staff are available in centers conducting Phase II, III, and IV trials.
- There remains a need for enhanced formal training in Good Clinical Practice (GCP) to further optimize clinical research.
Related Concept Videos
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...
01:11Clinical 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...
01:28Preclinical 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...
01:15Bioavailability 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,...
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...