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Related Concept Videos

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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Clinical Trials01:16

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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.
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Preclinical Development: Overview01:28

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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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Drug Administration and Therapy Phases: Overview01:26

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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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Pharmacovigilance01:19

Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

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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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The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time
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Overview of ACTIV trial-specific lessons learned.

Ruxandra Draghia-Akli1, Sarah W Read2, Eric A Hughes3

  • 1The Janssen Pharmaceutical Companies of Johnson & Johnson, Spring House, PA, USA.

Journal of Clinical and Translational Science
|October 31, 2024
PubMed
Summary
This summary is machine-generated.

The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership rapidly tested therapeutics for SARS-CoV-2. This public-private collaboration offers crucial lessons for future pandemic response strategies.

Keywords:
ACTIVCOVID-19drug testingmaster protocolspublic-private partnership

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Area of Science:

  • Public Health
  • Infectious Diseases
  • Clinical Trials

Background:

  • The COVID-19 pandemic necessitated rapid development of treatments and vaccines.
  • Public-private partnerships (PPPs) are vital for addressing global health crises.
  • The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative was formed to accelerate these efforts.

Purpose of the Study:

  • To provide an overview of the ACTIV partnership.
  • To highlight the structure and function of this large-scale public-private collaboration.
  • To set the context for subsequent articles detailing lessons learned from ACTIV.

Main Methods:

  • ACTIV established a global network for research and development.
  • Master protocols were designed and implemented rapidly for therapeutic testing.
  • Collaboration involved over thirty organizations and hundreds of individuals.

Main Results:

  • ACTIV facilitated the testing of numerous therapeutics for COVID-19.
  • The initiative demonstrated the potential of PPPs in pandemic response.
  • The speed and scale of ACTIV's operations were unprecedented.

Conclusions:

  • The ACTIV partnership serves as a model for future pandemic preparedness.
  • Lessons learned from ACTIV can inform best practices for novel pathogen response.
  • Effective collaboration is key to overcoming global health challenges.