Newsletter - September 3, 2020
Fraud at a Clinical Trial Company in Ohio Highlights Enforcement Challenges
A five-year long fraud by one clinical trial company on eight of its clients that was undetected by most till one of the clients got suspicious and complained to the FDA raises concerns about how clinical trials are audited by sponsors. Last month the Department of Justice charged eight individuals in Ohio with several counts...Read More
Can You Use Self Experimentation Data for FDA Approval of Products?
Testing products on oneself to demonstrate their potential is as old as science itself. But self-experimentation maximizes concerns regarding the conflict of interest and bias in reported results making any reports anecdotal at best. So, can one use data from self-experiments to support formal additional clinical trials or even market approval...Read More
Fraud at a Clinical Trial Company in Ohio Highlights Enforcement Challenges
A five-year long fraud by one clinical trial company on eight of its clients that was undetected by most till one of the clients got suspicious and complained to the FDA raises concerns about how clinical trials are audited by sponsors. Last month the Department of Justice charged eight individuals in Ohio with several counts...Read More
Can You Use Self Experimentation Data for FDA Approval of Products?
Testing products on oneself to demonstrate their potential is as old as science itself. But self-experimentation maximizes concerns regarding the conflict of interest and bias in reported results making any reports anecdotal at best. So, can one use data from self-experiments to support formal additional clinical trials or even market approval...Read More
