How to Reduce the costs of a successful TQT Study
Its very important when thinking about the conduct of a TQT study not to forget not ‘One Size Fits All’. Many study designs and ECG assessment methodologies have been looked at and posted for regulatory acceptance. The outcome of these studies as well as published guidelines is providing a growing pool of options for the design of future studies.
- Currently 35 TQT studies are listed on http://clinicaltrials.gov/
- There have been an increase in identified studies over recent years, rising from 1study in 2003 to 15 studies in 2009
- They are all varied in their design with subject numbers ranging from 30 to 300 i.e. 10 fold
- moxifloxin was used in all the studies as a positive control, which makes it remarkable
- Given that the sample sizes required to demonstrate assay sensitivity are now widely accepted to be around 40 subjects, with some authors suggesting sample sizes as low as 204
The 3 key elements of a successful TQT study are:
- An appropriate study design
- The quality of the ECG recorded during the clinical trial conduct
- The quality of the ECG analysis, Clinical Research Organisation and Clinical Trials procedures.
Study design
The intricate methods for ECG analysis applied to very large volumed of ECG traces is one of the main reasons for the associated large expenditures for TQT Studies.
Study designs need to ensure that the protocol directly fits the compound, thus allowing a reduction in the number of ECG recordings required without loosing the desired assay sensitivity. The protocols should ensure the highest possible quality of ECG recordings helping to vastly reduce cost and effort downstream.
ECG acquisition (during the study)
Bespoke design and subsequent analysis can become meaningless without good quality ECG data. |without quality ECG data, tailor made design and successive analysis can be worthless}
ECG (analysis)
Automatic reading of digitally recorded 10 second 12-lead ECGs and cardiologist over reading is the current gold standard. Not only QT intervals but all ECG parameters (PR, QRS and T-wave morphology) need to be analysed and reported.
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