Facebook
  1. Home
  2. Solutions
  3. TQT studies

Early phase TQT studies

ICON provides the expertise you need to develop a robust cardiac safety strategy, offering a one- stop shop combining state of the art clinical pharmacology units (CPUs) and a highly experienced cardiac safety core lab.

We have conducted numerous QT studies in our CPUs across the US and in The Netherlands. Regardless of study size, we have a strong track record enrolling large groups of subjects and meeting QT study timelines. With the growing focus on Intensive QT trials, our CPUs efficiently dose cohorts to accelerate data analysis, streamlining timelines for data safety committees and final report preparation.

Our services encompass optimised study designs, execution of cardiac safety studies, analysis of cardiac safety data, and regulatory reporting.  Additionally, our experts are available for discussions with regulatory agencies regarding cardiac safety.

Execution of QT studies

ICON utilises a range of ECG collection devices, including 12-lead ECG machines, telemetry, and Holter recorders, with data stored in FDA-compliant XML format for analysis by our ECG core lab. Our CPUs uniquely offer 12-lead telemetry, enabling ICH E14-compliant data collection and real-time safety monitoring—particularly valuable in First-in-Human (FIH) studies.


We conduct numerous FIH single and multiple ascending dose studies at our phase 1 units, where intensive ECG data collection can sometimes eliminate the need for a dedicated TQT study. 12 lead ECG data can be analysed immediately by ICON's core lab or stored for future use.  The ability to collect and store data is ideal when preclinical findings suggest a low risk of QT prolongation. This allows for analysis later, such as after proof of concept in patients, optimising short-term investment.

 

Benefits of early precision QT

 

Regulatory compliance & streamlined approval – Precision QT studies help meet ICH E14 guidelines early, potentially reducing the need for a separate Thorough QT (TQT) study later, accelerating regulatory approval.

Cost & time efficiency – By incorporating intensive ECG collection into first-in-human (FIH) and early-phase trials, precision QT studies can eliminate the need for costly, dedicated TQT studies, saving both time and resources.

Early risk assessment – These studies provide a robust early evaluation of QT prolongation risk, allowing sponsors to make informed decisions about drug safety before advancing to later phases.

Adaptive trial design support – Rapid ECG data analysis enables adaptive study designs, allowing dose adjustments and safety evaluations in real-time.

Improved data quality – Advanced ECG methodologies and high-precision analytics enhance the ability to detect subtle QT effects, increasing confidence in cardiac safety assessments.

In this section

Connect with us