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 rather novel and there may still be a degree of uncertainty for those commissioning these studies.
3 causes’ of this uncertainty is outlined below:
• 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
undertaking the conduct, design, analysis and concept
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 Europe’s leading CRO 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 Drug Development
Key elements
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
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