Monday, February 4, 2008

Offshoring clinical trials - welcome to 2008

It almost seems like an ethical nightmare when companies are considering offshoring so many vitally American business processes, such as when the Orlando Sentinel wanted to send our journalism overseas.

What about offshoring clinical trials? I am sure that there are many ethics involved in that one. I'm not a doctor, I'll admit, but I did once work in a company that marketed clinical research trials to American doctors. I signed a confidentiality on that one, but from my short-lived perspective, many pharmaceutical companies were, well, desperate to get doctors to test their products on patients. It wasn't pretty and I was relieved when that temporary assignment was over.

Does this scare anybody else? 10% of the trials listed at Clinicaltrials.org, out of the 50,000 of clinical trials currently underway - are being tried outside North America, typically in western Europe and Japan. On top of that, ClinicalTrials.org is the website that our government uses to do clinical testing. Creepy, anyone? There's a really long article about the trend of companies like GlaxoSmithKline transfer of clinical trials overseas at the Financial Times, but you have to register to get access to it. It's interesting to note that some big corporations don't see it as a problem - in fact, they may even see it as a solution to the prying eyes of the FDA and the regulations that slow down the drug approval process... Which they view as an unnecessary evil...

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