Why QST in Analgesic Clinical Trials?
Phenotyping patients based on underlying pain mechanisms
QST is a powerful tool for phenotyping and stratifying subjects based on underlying pain mechanisms. This allows to identify and recruit patients who are expected to benefit the most from the treatment.
Demonstrating the clinical efficacy of potential analgesics is challenging, as observed by the unfortunate high rate of failed analgesic trials. In most cases, only a subgroup of the population responds, while in the entire cohort, the study might fail to demonstrate superiority over placebo. Hence, the ability to predict who will benefit from a given treatment is of enormous importance. Evidence supporting the value of thermal Quantitative Sensory Testing (QST) in phenotyping and predicting analgesic response has accumulated over the past years.
“… the European Medicines Agency (EMA) has recently acknowledged […] that sensory profiling and subgrouping […] is an adequate stratification tool for determining specific sensory phenotypes of patients…” (EMA 2016, Baron et al., 2017)
Secondary outcome measures
QST provides quantitative and standardized secondary measures to assess the analgesic efficacy and support extended labeling of the investigated compound.
Safety outcome measures
QST can be used to monitor small fiber function, and assure that no harm is caused by the investigated compound.