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Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase.

Author: BensonC, DarpoB, DotaC, FerberG, GarnettC, GreenC L, JarugulaV, JohannesenL, KeirnsJ, KrudysK, LiuJ, Ortemann-RenonC, RileyS, SarapaN, SmithB, StockbridgeN, StoltzR R, ZhouM

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

This study assessed whether exposure-response analysis can detect QT effects of drugs in a small study with healthy subjects. Five 'QT-positive' drugs and one negative drug were tested at two dose levels. The results indicate that robust QT assessment in early-phase clinical studies can potentially replace the thorough QT study for identifying QT effects.
Paper Details　
Original Abstract of the Article :
The QT effects of five "QT-positive" and one negative drug were tested to evaluate whether exposure-response analysis can detect QT effects in a small study with healthy subjects. Each drug was given to nine subjects (six for placebo) in two dose levels; positive drugs were chosen to cause 10 to 12 ...See full text at original site
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引用元：
https://doi.org/10.1002/cpt.60

データ提供：米国国立医学図書館（NLM）

QT Assessment in Early Clinical Trials: A Paradigm Shift

This study investigated the feasibility of replacing the traditional thorough QT study with a more efficient and robust QT assessment in the early clinical phase of drug development. The researchers evaluated the QT effects of six drugs, including five known to prolong QT intervals and one negative control drug, using a small cohort of healthy subjects.

Exposure-Response Analysis: A Promising Alternative to Thorough QT Studies

The study demonstrated that exposure-response analysis could effectively detect QT effects in a small study with healthy subjects. The findings suggest that this approach can potentially replace the more resource-intensive thorough QT study, streamlining the drug development process while maintaining safety and efficacy.

Efficient and Robust QT Assessment: A Valuable Tool for Drug Development

This study highlights the potential of robust QT assessment in early-phase clinical studies as a valuable tool for drug development. The approach offers a more efficient and cost-effective method for detecting QT effects, potentially leading to faster and more efficient drug development.

Dr. Camel's Conclusion

This study explores a potential paradigm shift in drug development by advocating for a more efficient and robust QT assessment in early clinical phases. The researchers demonstrate the effectiveness of exposure-response analysis in detecting QT effects in a small study, potentially revolutionizing the traditional approach to QT evaluation.
Date :
  1. Date Completed 2015-05-12
  2. Date Revised 2015-06-16
Further Info :

Pubmed ID

25670536

DOI: Digital Object Identifier

10.1002/cpt.60

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