| Thorough QT/QTc (TQT) studies are one of the | | | | early phase studies. |
| most important elements of new drug development. | | | | Essentials |
| These studies are significant and their outcome has | | | | These studies could be conducted at a much earlier |
| major impact on a drug development program. | | | | stage of development and in any case |
| Despite, TQT Studies are rather novel and there | | | | morefrequently, if a there is a significant reduction in |
| may still be a degree of uncertainty for those | | | | cost, based on 3 key elements can beachieved. |
| commissioning these studies. | | | | These are: |
| Some of the reason for this may be: | | | | - Design |
| - Best practice for the conduct of TQT studies is still | | | | - Conduct |
| emerging | | | | - Analysis |
| - Overall, these studies are generally expensive to | | | | Conclusions |
| conduct | | | | The conduct of (TQT) studies is expensive due to |
| - ECG central core laboratories do not have any | | | | the analysis of excessive volumes of ECGs and the |
| incentive to develop efficient methods for assessing | | | | separation between clinical units and ECG core |
| NCEs undertaking the conduct, design, analysis and | | | | laboratories. Additional expenses may arise from |
| concept | | | | excessive volunteer numbers. |
| A positive indication attained from TQT studies does | | | | This cost can be reduced if TQT studies are well |
| not mean that new chemical entities will cause TDP | | | | designed, well conducted and appropriately analysed. |
| with connected threat of unforeseen death; | | | | Based on this, These studies may be carried out |
| however a positive signal has a major impact on the | | | | earlier in the drug development program or in any |
| development of a NCE. For this reason, the early | | | | case will lead to a reduction in drug development |
| conduct of a (TQT) study is desirable but the cost | | | | cost. |
| may be prohibitive given the high attrition rate in | | | | |