The conduct of PONV clinical trials has significant impact on their assay sensitivity. This is in part due to the strict experimental controls needed to demonstrate an effect in PONV, which are sometimes contrary to standard clinical practice.
Rescue vs. Prophylaxis
One key study conduct issue to manage in PONV trials is the threshold for PONV rescue medication, and delineating the difference between rescue and prophylaxis for investigators and staff. Clinicians are accustomed to a much lower threshold for PONV rescue than is optimal for a clinical trial, where some PONV must be observed to demonstrate an effect.
In many hospitals, when a patient experiences even mild nausea, or might get nauseated, the patient is treated. This can occur to the point where the medication is prophylaxis rather than treatment, which negatively affects study outcomes. Lotus uses proprietary investigator training methods to ensure that PONV investigators are properly educated to prevent unnecessary prophylaxis/ pre-treatment and avoid falsely negative outcomes.
Controlling Confounding Medications
Many intraoperative analgesics and anesthetics have antiemetic properties (such as Decadron and others). It’s critical to achieve alignment from anesthesia staff prior to initiating PONV treatment and to strictly control these medications. Lotus employs multiple techniques to ensure that study staff accustomed to standard of care treatment maintain strict compliance to PONV clinical trial protocols.
The below abstract provides some perspective on some of Lotus’ scientific work Lotus has performed to optimize the methodology of PONV studies. This abstract discusses comparative PONV effect sizes at Lotus’ Pasadena site vs. an aggregate of multiple sites. It also highlights the enrollment rate at our single high-enrolling center in a PONV study (Lotus enrolled 95 subjects while 28 other sites collectively enrolled 638 subjects).
Treatment Effect May Be Easier to Detect in a High Enrolling Single Center- Case Study in PONV