INC Research Holdings, a global phase I to IV CRO, has been certified to use the iCardiac Early Precision QT approach for evaluating the cardiac safety of new compounds in phase I clinical development. INC’s use of iCardiac Early Precision QT may help customers reduce costs, and increase the accuracy, reliability and speed of cardiac safety testing in clinical research.
“INC Research continually seeks innovations that enhance the full drug development lifecycle,” said CEO Jamie Macdonald. “Achieving certification to conduct trials using iCardiac Early Precision QT is a prime example of the company’s focus on driving efficiency for customers through new approaches. As drug development becomes increasingly complex and the amount of data captured, stored and applied multiplies exponentially, this approach has the potential for significant time and cost savings for customers.”
Since 2005, the FDA has required all new compounds under development to be tested to determine their impact on the QT interval—the time between the start of the Q wave and the end of the T wave during the heart’s electrical cycle. A lengthened QT interval indicates potential safety risk factors for a new drug.
With the technology in place, INC may be able to eliminate the need for a separate, dedicated Thorough QT (TQT) study, which can cost between $2 million and $5 million. By applying the approach, INC can help companies spend only a fraction of that amount and collect cardiac safety data during phase I trials rather than during later stage trials. By making cardiac safety assessments earlier in clinical development, researchers may be able to speed the development process, help to avoid promising drugs being inappropriately eliminated through inaccurate cardiac data, bring new therapies to market sooner, better allocate resources and reduce spending.