Home > Property & Casualty > Computer simulators mean heightened standards for clinical drug trials

Computer simulators mean heightened standards for clinical drug trials

drug simulatorRecent reports in the Wall Street Journal outline important developments in safety and efficacy standards for human clinical trials of drugs and devices. Drug companies are now using computer simulations in order to determine key clinical trial design features. Previously, issues like the length of trial were based on judgment and experience of the trial sponsor. With this new United Stated Food and Drug Administration and European Medicines Agency endorsed design protocol simulators, the bar has been raised for human testing.

Every time that regulators approve and endorse new technologies, they increase the standards for trial sponsors. In a case where a participant alleges harm from the trial, the absence of this capability may weaken the defense of any claims. So, drug and device companies need to strongly consider raising their game in order to have the additional legal protection that the program implies. Insurers certainly look for sponsors to work at the cutting edge of accepted trial practices. It would not be surprising to see insurers using this new development in their applications and rating of insurance premiums.

About the Author

Phil Edmundson is the Chairman and CEO of William Gallagher Associates, insurance brokers and consultants for businesses with over 30 years in the insurance industry. He manages strategy, talent acquisition and development, and management / acquisitions at WGA.

617.646.0229 | PEdmundson@wgains.com | Connect with Phil on LinkedInFollow Phil @PhilEdmundson

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