Successful TQT Studies
TQT Studies are an indispensible part of the development of new chemical entities (NCE). TQT Studies is a major contributor to a new drug development program. Though, TQT Studies are rather 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 signal in a TQT study does not mean that a NCE will cause Torsades de Pointes (TdP) with the associated risk of sudden death.
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 leading CRO specialising in Thorough QT/QTc, Clinical Data Management and Clinical Research. With a Core ECG Lab and experienced medical professionals Richmond Pharmacology conducts Clinical Trials for the purpose of new Drug Development
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 are
• Design
• Conduct
• Analysis
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