Successful TQT Studies
Thorough QT/QTc (TQT) studies are one of the most important elements of new drug development. These studies are significant and their outcome has major impact on a drug development program. However, these studies are fairly novel and there may still be a level of doubt when assigning the studies
Some of the reason for this may be:
• Best practice for the conduct of TQT studies is still emerging
• Overall, these studies are generally expensive to conduct
• ECG central core laboratories do not have any incentive to develop efficient methods for assessing NCEs
Tackling concept, design, conduct, analysis and interpretation
A positive indication attained from TQT studies does not mean that new chemical entities will cause TDP with connected threat of unforeseen death, though…
A positive signal has however a major impact on the development of a NCE. For this reason, the early conduct of a TQT study is desirable but the cost may be prohibitive given the high attrition rate in early phase studies.
Richmond Pharmacology is the UK’s top Clinical Research Organisation specialising in Thorough QT/QTc, Clinical Data Management and Pharmaceutical Research. With a Core ECG Lab and experienced medical professionals Richmond Pharmacology conducts Clinical Trials for the purpose of new NCE
Essentials
TQT studies could be conducted at a much earlier stage of development and in any case more
frequently, if a there is a significant reduction in cost, based on 3 key elements can be
achieved.
These Elements are:
• Design
• Conduct
• Analysis