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Related Concept Videos

Clinical Trials: Overview01:11

Clinical 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...
Issues And Trends In Healthcare Delivery System01:29

Issues And Trends In Healthcare Delivery System

The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
Pharmacovigilance01:19

Pharmacovigilance

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.
In some cases, there...
Clinical Trials01:16

Clinical 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...
Preclinical Development: Overview01:28

Preclinical 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...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).

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Related Experiment Video

Updated: Jul 3, 2026

The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time
06:05

The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time

Published on: February 19, 2021

Postmarket evaluation of breakthrough technologies.

Sunil V Rao1, Robert M Califf, Judith M Kramer

  • 1Duke Clinical Research Institute and Duke University Medical Center, Durham, NC 27705, USA. sunil.rao@duke.edu

American Heart Journal
|July 29, 2008
PubMed
Summary
This summary is machine-generated.

The increasing use of cardiovascular medical devices necessitates improved safety evaluations. Experts propose enhancing premarket and postmarket surveillance to ensure patient safety with novel technologies.

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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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Area of Science:

  • Cardiovascular Medicine
  • Medical Device Technology
  • Regulatory Science

Background:

  • Cardiovascular procedures have surged due to an aging population, obesity, and diabetes.
  • Novel medical devices are increasingly used, often with expedited Food and Drug Administration (FDA) review.
  • Concerns about device safety have risen due to high-profile defects.

Framework:

  • A think tank convened experts from industry, regulatory bodies, and academia.
  • Case studies included drug-eluting stents and implantable cardioverter-defibrillators.
  • Challenges identified include accurate event rate determination and industry monitoring disincentives.

Implementation:

  • Proposed solutions involve strengthening regulations and enforcing compliance.
  • Creative study designs linking pre- and postmarket data were suggested.
  • Making postmarket surveillance a public health priority is recommended.

Implications:

  • Financial incentives for postmarketing studies and improved animal models are proposed.
  • Encouraging postmortem device retrieval can enhance safety data.
  • Aligning professional societies with the FDA can improve technology evaluation and communication.