Problem/Solution in Clinical Research
To gauge a patient's pain state, clinical researchers use the visual analog system (VAS) which is a scale between 0-10 (0: no pain & 10: worst pain imaginable). Patient’s are ASKED to report their pain levels between 0-10 pre and post intervention; if a reduction is shown relative to placebo than the drug is considered efficacious.
Problems with Current Methodology:
Patients are terrible at providing a good estimate of their internal state and have no good basis for differentiating between pain states especially in the middle of the scale: 3-7.
Problems with Current Methodology Lead to:
High failure rate of pain drugs due to heterogeneous/internal variability patient pain reporting
Increased cost of clinical trials caused by the necessity smooth out variability in patient pain reporting by having large patient sample sized
Lack of investor interest due to erratic measurement of end point
Current Standard of Care
PainQx solves the logic chain below by providing:
Objective Pain Measurement: Reduces clinical trial costs and risks
Scaled Pain and Neurological Side-effect Biomarkers: Improves data, research outcomes; validates research products
Measuring A Patient’s Pain State With PainQx:
Patients’ brain waves are analyzed pre and post intervention. PainQx generates a PQ score for each patient between 0 – 10. If a reduction is shown relative to placebo than the drug is considered efficacious.
Advantages of PainQx Methodology:
The PQ score is a quantifiable and objective measurement that can be used to use to evaluate the efficacy of analgesic drug:
Removes the need of a patient to verbalize their pain state.
Removes sociological influences on the patient as clinician does not have to verbally administer the test.
Requires no esoteric equipment and can be easily implemented in IRB.
Advantages of PainQx System Lead to:
Reduces failure rate of pain drugs by providing objective, homogenous patient pain reporting.
Clinical trial costs are significantly curtailed due to reduced sample sizes needed since patient reporting variability has been decreased.
Increased investor interest as end points become less erratic, increasing the likelihood of FDA approval.