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During the early stages of clinical development, the ability of new drugs to delay cardiac repolarisation is of key concern. As a result, dedicated clinical pharmacology studies designed to examine the effects on cardiac repolarisation have become increasingly important to the pharmaceutical industry and are today an integral component in the development of new chemical entities (NCEs) and ongoing drug development programmes for new drug submissions. These studies, known as ‘thorough QT/QTc studies’ (TQT), are now so significant that they can determine the course, and indeed the viability, of an entire drug development programme.
The first governing body to issue guidance in the form of a ‘Points to Consider’ document was the European Agency for the Evaluation of Medicinal Products (EMEA) in 1997. More recent regulatory guidance for TQT analysis has raised new considerations and challenges when designing drug development programmes. The successful completion of a TQT study in the digital ECG era is highly dependent upon superior technology and efficient, predefined processes to properly manage ECGs.
THE KEY ELEMENTS TO A SUCCESSFUL TQT STUDY
TQT studies came to prominence in order to give an early indication of QT prolongation in human subjects, as a signal of the potential of Torsades de Pointes (TdP). Through a reduction in cost by an appropriate and equal emphasis on the three key elements of these studies, TQT studies could more regularly be conducted at a much earlier stage of development of a NCE. If this were to occur, the resulting signal, positive or negative, will help shape the further development of a compound, rather than just being a regulatory necessity. The key elements to achieve a successful TQT study are: |
