Clinical Trials Administrator Archives – July 1, 2006
July 1, 2006
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For-profit vs. non-profit: Sponsor type affects study outcomes
It may not surprise most people in the clincial trials industry, but a new study says that when cardiovascular trials are funded by for-profit sponsors they are more likely to report positive findings. -
National registry has grown to near 30,000 studies
Clinical trial registration rapidly is gaining acceptance and soon could be a standard for researchers and sponsors alike. -
UPenn's clinical trials registry going public
The University of Pennsylvania in Philadelphia rolled out its own on-line clinical trials registry nearly a year ago as a trials recruitment tool. -
Investigator training often lacks practical info
Studies continue to show a high turnover rate of investigators, which has resulted in a pattern in which only 10% of investigators have significant experience in clinical trials. Furthermore, there was a 1,000% increase in complaints to the FDA about investigators between 1998 and 2003. -
Research or innovation? Document differences
The IRB process has become more prominent and formal in recent years, and as a result of that change there have been conflicts about the IRB's reach: Is everything that involves a new treatment and outcomes measurements considered research and subject to IRB review? -
UK clinical trial disaster: One man still hospitalized
Two months after the clinical trial disaster that sent six healthy volunteers into intensive care and left one man still hospitalized by the end of May, a British investigation found no apparent errors or cause for the adverse events.