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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

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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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The case management model is a multidisciplinary approach that involves healthcare professionals from diverse disciplines, such as physicians, nurses, therapists, social workers, and pharmacists, working collaboratively to address the various needs of patients. Each healthcare professional brings unique expertise and perspectives, contributing to a more comprehensive understanding of the patient's condition and tailoring treatment plans accordingly.
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Investigation of Disease Outbreaks01:23

Investigation of Disease Outbreaks

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Multistate foodborne outbreaks pose significant public health risks and require meticulous investigation to identify sources and implement control measures. The Centers for Disease Control and Prevention (CDC) utilizes a dynamic seven-step process for these investigations, integrating data from laboratories, interviews, and environmental assessments to protect public health.Outbreak Detection: The detection of multistate outbreaks typically begins with PulseNet, the CDC's national laboratory...
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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.
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eGEMs: Pathways to Success for Multisite Clinical Data Research.

Deven C McGraw Jd1, Alice B Leiter Jd1

  • 1Center for Democracy and Technology.

EGEMS (Washington, DC)
|April 8, 2015
PubMed
Summary

Leveraging electronic clinical data (ECD) for research faces governance challenges. This paper shares experiences from nine initiatives, showing privacy-protective, compliant data sharing is achievable.

Area of Science:

  • Health Informatics
  • Data Governance
  • Clinical Research

Background:

  • Secondary use of electronic clinical data (ECD) is crucial for health reform but presents significant data stewardship and governance challenges.
  • Access, use, and disclosure of electronic health record (EHR) data for quality improvement and research involve complex legal, policy, and procedural issues.
  • Effective data governance is essential for unlocking the full potential of clinical data beyond individual patient care.

Purpose of the Study:

  • To detail the experiences of nine multisite research initiatives in navigating challenges related to the secondary use of ECD.
  • To document resources and strategies employed by research projects to overcome data-sharing hurdles.
  • To validate the feasibility of privacy-protective and legally compliant cross-site clinical data sharing.

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Main Methods:

  • Qualitative analysis of experiences from nine multisite research initiatives across the United States.
  • Documentation of challenges encountered in accessing, using, and disclosing EHR data for research.
  • Collection of strategies and resources utilized by project participants to address data governance issues.

Main Results:

  • Identified numerous legal, policy, and procedural challenges in secondary ECD use.
  • Documented practical navigation strategies and resources used by multisite initiatives.
  • Validated that privacy-protective, legally compliant clinical data sharing across sites is currently possible.

Conclusions:

  • Multisite research initiatives can successfully navigate ECD governance challenges.
  • Sharing collective experiences and resources is vital for advancing health data governance.
  • The findings provide a foundation for a community 'governance toolkit' to foster best practices in data sharing.