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Related Concept Videos

Clinical Trials01:16

Clinical Trials

8.5K
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

4.7K
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...
4.7K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

627
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,...
627
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

300
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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Drug Discovery: Overview01:26

Drug Discovery: Overview

10.3K
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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Establishment of a Clinic-based Biorepository
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Establishment of a Clinic-based Biorepository

Published on: May 29, 2017

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Establishing a successful clinical research program.

Daniele Scoglio1, Alessandro Fichera1

  • 1Department of Surgery, University of Washington Medical Center, Seattle, Washington.

Clinics in Colon and Rectal Surgery
|July 29, 2014
PubMed
Summary
This summary is machine-generated.

Establishing a successful clinical research (CR) program in surgery requires a dedicated team and a strong foundation of original ideas. This approach enables critical review of results and development of new surgical strategies.

Keywords:
clinical research programclinical research teamevidence-based medicinerandomized controlled (clinical) trialtranslational research

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Area of Science:

  • Surgical innovation and clinical research methodologies.

Background:

  • Clinical research (CR) is essential for surgical practice, allowing for critical evaluation of outcomes and strategy development.
  • Surgical practices often face time constraints that can hinder dedicated research efforts.

Purpose of the Study:

  • To outline critical factors and components for establishing a successful clinical research program within surgical practices.
  • To provide a framework for surgeons to integrate research into their clinical work.

Main Methods:

  • Emphasis on building a dedicated research team to overcome practical limitations.
  • Structuring a research program based on original ideas and testable clinical hypotheses.
  • Leveraging personal experience and existing evidence to formulate research questions.

Main Results:

  • A dedicated team is the primary factor in prioritizing and executing CR.
  • Developing novel hypotheses is crucial for program initiation.
  • Randomized controlled trials offer the highest level of evidence for intervention-outcome relationships.

Conclusions:

  • Successful clinical research programs in surgery are built upon dedicated teams and well-defined hypotheses.
  • Translational research can bridge basic science discoveries with clinical applications.
  • Systematic CR enhances surgical practice through evidence-based strategy development.