Please Wait...

To Thorough QT or Not to Thorough QT – That is the question

Thanks to scientific advancements and increased understanding of pathways and systems that contribute to cardiac risk, the cardiac safety ECG environment continues to mature and expand. Presently, the assessment of QT/QTc from the electrocardiogram is the primary focal endpoint in cardiac safety.

Examining the progress made over the past decade takes me back to 2006 when early discussions around implementation of ICH E14 guidance were taking place. It was at DIA's annual conference that year where I had the opportunity to organize a session, QT Dossier – The Impact of ECG Data from a Regulatory Perspective, in a panelist discussion with the FDA and industry representatives.Since then, we've had a lot of thoughtful and productive discussion within the industry, resulting in some important Q&A around ICH E14.

Initially, when the ICH-E14 came out proposing/requiring the conduct of a dedicated study to evaluate the QT effect ─ the Thorough QT (TQT) study ─ there was concern over cost and the impact on drug development this additional study would have. Fortunately, through advancement in TQT trial design, industry market pressures and other factors, the cost of a TQT study is actually lower today than the initial TQT studies conducted when the ICH-E14 was initially implemented.

Advancements and direction for evaluating the cardiac safety during the drug development process are highlighted in the most recent ICH-E14 Q&A and the ensuing cardiac safety conferences and industry meetings. One discussion centers on whether or not a formal TQT is necessary as part of the development program, with more of a focus on exposure response/ concentration effect analysis associated with the QT.

With the responses to the ICH E14 Q&A and options available to address cardiac safety requirements for developing therapeutic treatments/compounds, there are some key "points to consider" from a drug development consideration. These include:

  • What are the potential financial considerations and impact for the biopharmaceutical organization when determining which trial design and path to take to address the cardiac safety regulatory requirements
  • For biopharmaceutical organizations developing a compound, how do they determine the best path and types of trials to conduct to address the cardiac safety requirement?
  • Is it still appropriate to conduct and submit a formal TQT study?

A number of these discussion points have been raised during industry meetings, including a review of a potential decision tree approach to assist in defining approaches to trial design and considerations.

These are but a few of the topic points that Bioclinica's cardiovascular safety & medical imaging team will be exploring at upcoming industry conferences, meetings and webinars. We'd love to hear your perspectives and insights, so please join us during our forthcoming interactive webinar entitled, "Cardiovascular Safety in Biopharmaceutical Product Development – From QT Prolongation and Beyond" and/or drop me a line anytime!

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

Congrats @bioclinica on @Clin_Info_News Best Practices Award 4 "Transformational Med. Imaging in #ClinicalTrials. '… https://t.co/NxauNywq23
bioclinica (Yesterday)
RT @BrianSMcGowan: Allison Proffitt Editor of Clinical Informatics News, Best Practice Awards @ from Clin_Info_News ... recognizing applied…
bioclinica (3 days ago)
@Clin_Info_News @IQVIA_global @CRFHealth All of us @Bioclinica are truly honored to receive this recognition. Congr… https://t.co/mULb8tatJ2
bioclinica (3 days ago)
RT @Clin_Info_News: Congrats again to @IQVIA_global @CRFHealth @bioclinica on winning the @Clin_Info_News Best Practices awards at #SCOPE20…
bioclinica (3 days ago)
And the winner is! Transformational Medical Imaging in #ClinicalTrials: @bioclinica SMART. @Clin_Info_News Best Pra… https://t.co/IYZoWoK8CB
bioclinica (3 days ago)
Folks at #SCOPE2018 hearing from Eric Forsthoffer and Rebecca Lupo about Bioclinica's Site Network.… https://t.co/aHRJtHb6zz
bioclinica (3 days ago)

Latest Blogs:

Latin America: Benefit from the Right Partner
Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
The Value of Protocol Review
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen