The use of QST devices in pharma-sponsored clinical trials
has been continuously rising over the past couple of years.
This welcomed surge of QST incorporation into clinical trials comes as no surprise with the growing understanding in both the research and pharma communities regarding the benefits of QST in enhancing the success rates, safety and label extension in analgesic pharma clinical trials.
There are three main applications for QST in this arena: phenotyping, secondary outcome measure and safety.
QST is a powerful tool for phenotyping and stratifying subjects based on underlying pain mechanisms. This allows to identify and recruit only patients who are expected to benefit from the treatment. It is currently recommended to phenotype subjects using QST at baseline, in order to predict treatment response.
We are happy to share the use of the Q-Sense system in a pharma Phase II multi-site clinical trial, used to phenotype patients based on their hot pain, warm sensation and cool sensation thresholds. This helps determine the functionality of patients’ small-fibre and whether they could substantially gain from participating in the trial.
QST can also provide a quantitative and standardized secondary analgesic efficacy measure to assess the analgesic efficacy of the investigated compound and support its extended labeling. In fact, both the Q-Sense with its thermal measurements and the AlgoMed with Pain Pressure Threshold (PPT) are now being used as secondary efficacy measures in Phase II and Phase III multi-site clinical trials across the US, Europe and APAC.
Lastly, QST supports establishing the safety of the investigated compound by continuous monitoring of small-fiber function, and assuring that no sensory deterioration is caused during the trial.
The application of Medoc’s QST devices is simple and easy to use in a multi-site setting, even with inexperienced operators. This is possible by virtue of Medoc’s hand-in-hand approach as well as the extensive professional services provided by Medoc through the planning stages, investigator meetings and training, and throughout the duration of the clinical trial itself.