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Related Concept Videos

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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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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Preclinical Development: Overview01:28

Preclinical Development: Overview

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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...
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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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Drug Discovery: Overview01:26

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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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Planning for the unexpected: Strategies for maintaining a robust clinical trial program.

Lemuel F Melecio Rodríguez1, Jessica Hernandez1, Julyann Pérez-Mayoral2

  • 1University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.

Contemporary Clinical Trials Communications
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Hurricanes pose significant challenges to clinical trials in Puerto Rico. Developing emergency plans and budgets can help mitigate disruptions caused by natural disasters.

Keywords:
Clinical trialsEmergency plansNatural disastersProtocol maintenance

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Area of Science:

  • Clinical research
  • Disaster preparedness
  • Public health

Background:

  • Puerto Rico is historically vulnerable to hurricanes.
  • Clinical trials face significant challenges during natural disasters.
  • Hurricane Maria (2017) severely impacted Puerto Rico.

Purpose of the Study:

  • To identify challenges faced by clinical trials during Hurricane Maria.
  • To outline strategies for overcoming disaster-related disruptions in research.

Main Methods:

  • Assessed participant needs post-disaster.
  • Facilitated aid distribution (food, water, medicine).
  • Resumed trial protocols and arranged participant transportation.

Main Results:

  • Identified key challenges: infrastructure damage, resource shortages, transportation, and communication failures.
  • Provided essential aid to participants.
  • Successfully resumed clinical trial activities.

Conclusions:

  • Emergency planning and dedicated budgets are crucial for maintaining clinical trial continuity during natural disasters.
  • Proactive measures can mitigate the impact of hurricanes on research participants and protocols.