Biomedical companies hiring research organizations, many not scrutinized by the FDA...how credible are the results reported, as this article investigates...are there any standards...any standards available? BD
The huge cost and complexity of testing potential new medical products - a forbidding burden for fledgling Silicon Valley biotech firms - has given birth to an army of entrepreneurs offering to do the tests for others. Hundreds of Contract Research Organizations have cropped up over the past two decades around the world, creating a multibillion-dollar industry that many people say provides an essential service and is bound to expand. But some say the trend has a troublesome side, according to The San Jose Mercury News.
“CROs are just out there kind of doing their thing,” Arthur Caplan, who heads the BioEthics center at the University of Pennsylvania, tells the Merc. “They need to be the object of more regulatory attention partly just to establish how well they are doing. It will take a scandal a la Chinese lead paint in toys for that to happen.” He contends the FDA barely keep tabs on companies now, given its limited resources.
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