TheraSim

TheraSim Clinical Trials

TheraSim’s products assist clinicians in the acquisition and processing of medical
knowledge and reduce the variation in clinical care delivery and drug development

 

Sites Make Mistakes And Human Error Is The Largest Cause

  • 44% of clinical error is due to knowledge or skill deficit
  • Current approaches address errors and deviations from protocol after they occur
  • CPM predicts and prevents these errors using simulation, e-mentoring and adaptive learning

Medicine is complicated and prone to error. This ubiquitous problem is costly in terms of both dollars and human life. According to the NIH, avoidable medical error has risen from the #9 to the #6 cause of death in the United States. The same sites that are plagued by this systemic problem are also participating in clinical trials. The error rate in the US alone, is roughly equivalent to the number of deaths that would occur if a commercial airliner crashed every day. Unlike healthcare, however, commercial aviation has a dramatically improving safety record. The death rate on commercial aircraft has dropped from one death for every million miles flown to one death every billion miles. The development and widespread adoption of continuous process improvement (CPI) technology in the form of flight simulators and autopilots are a significant contributing factor in this dramatic improvement.

Managing clinical trials adds several layers of complexity to clinical care, further increasing the opportunity for medical and administrative errors. TheraSim CPM harnessess the power of simulation, analytics and adaptive learning to bring the same benefits of consistent human performance to clinical trials.

 

In a study of budgets for 80 phase 3 clinical trials, 27% of total expenses was budgeted to remediation of protocol violations while only 3% to training and other proactive measures designed to prevent protocol deviations. In addition, many protocol violations go undetected and have a hidden but adverse impact on efficacy and safety data. TheraSim CPM measures the behaviors required to deliver a successful trial based on the protocol. Using interactive computer simulation of study subjects, TheraSim CPM detects and improves weak behaviors and reduces the deviations from protocol saving time, saving money and reducing risk.

Protocal deviations are the greatest area of deficiency in FDA inspections. TheraSim CPM moves this process to prediction and prevention from remediation.

Back