TQT Studies: Reducing the Costs Involved
Its imperative when thinking of the conduct of a TQT study to always consider not ‘One Size Fits All’. Lots of study designs and ECG assessment methodologies have been tested and posted for regulatory acceptance.
The result of these studies as well as published guidelines is providing an ever growing list of options for the design of future studies.
- Presently the Clinical Trials Website (http://clinicaltrials.gov/) has 35 TQT Studies listed on it
- The following shows the studies that we have identifies; 2003 – 1, 2004 and 2005 – 2, 2006 – 5, 2007 – 6, 2008 – 15 , and 2009 - 4
- With subject numbers ranging from 30 to 300 the studies all vary in design
- This is remarkable considering that these studies all used moxifloxacin as a positive control
- 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 sophisticated methods for ECG analysis applied to huge amounts 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, 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.
