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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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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...
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Kaplan-Meier Approach

The Kaplan-Meier estimator is a non-parametric method used to estimate the survival function from time-to-event data. In medical research, it is frequently employed to measure the proportion of patients surviving for a certain period after treatment. This estimator is fundamental in analyzing time-to-event data, making it indispensable in clinical trials, epidemiological studies, and reliability engineering. By estimating survival probabilities, researchers can evaluate treatment effectiveness,...
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Related Experiment Videos

Updating clinical endpoint definitions.

Paul M Hassoun1, Sylvia Nikkho, Erika B Rosenzweig

  • 1Johns Hopkins University, Baltimore, Maryland, USA.

Pulmonary Circulation
|May 11, 2013
PubMed
Summary
This summary is machine-generated.

The 6-Minute Walk Distance (6-MWD) is a common measure for pulmonary arterial hypertension (PAH) drug trials. Experts convened to discuss its limitations and explore more reliable endpoints for assessing PAH treatment efficacy.

Keywords:
clinical trialsend-pointspulmonary arterial hypertension

Related Experiment Videos

Area of Science:

  • Cardiology
  • Pulmonology
  • Clinical Trials

Background:

  • The 6-Minute Walk Distance (6-MWD) has been the primary efficacy endpoint in pulmonary arterial hypertension (PAH) clinical trials for 20 years.
  • Despite its widespread use and prognostic value, the 6-MWD faces criticism for not fully reflecting disease severity or treatment response.

Purpose of the Study:

  • To address the limitations of the 6-MWD as an endpoint in PAH clinical trials.
  • To discuss and evaluate current and emerging endpoints for assessing PAH therapy efficacy.

Main Methods:

  • A conference was convened in early 2012.
  • Participants included PAH experts, regulatory agency representatives, and pharmaceutical company representatives.
  • The meeting focused on the validity of existing and novel endpoints for PAH.

Main Results:

  • The proceedings of the conference are presented.
  • Discussion centered on the need for more reliable endpoints than the 6-MWD.
  • Exploration of alternative measures reflecting pulmonary vascular resistance and cardiac status in PAH.

Conclusions:

  • The 6-MWD's limitations necessitate the exploration of alternative endpoints in PAH research.
  • Further validation of emerging endpoints is crucial for accurately assessing PAH treatment efficacy.
  • Expert consensus is moving towards more comprehensive outcome measures in PAH clinical trials.