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Old 05-05-2012, 07:22 AM   #1
jpm
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Default Clinical Trials

Hi,

Clinical Trials - Everyone talks about the FDA trials - which I presume is solely American?

What about the rest of the world, how do these treatments get passed for approval say in the UK/EU/Asia etc. Is it a case that as soon as they pass FDA trials they can be sold anywhere in the world. I never hear of any other country doing trials on these new treatments.

Also, people have mentioned that treatments could be available in Asia sooner than other countries? Why is this?

Cheers
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Old 05-05-2012, 10:18 PM   #2
Pate
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It could be available sooner in Asian countries because there is less red tape and fewer administration issues standing in the way of getting them approved.

The FDA is sort of the benchmark for two reasons, firstly the US is the biggest single target market (though the combined EU is probably now bigger) and secondly the FDA protocols are pretty strict. I think this partly came out of the thalidomide scare in the 1950s. The US never approved thalidomide for sale but it was a near-run thing, and the US and world in general learned about the importance of proper clinical trials from what happened with thalidomide.

In most other countries there is a similar organisation to the FDA, but if a company comes to them and can point to their product having received FDA approval, it will probably be easier for them to get approval in those other countries.

It's more practicality than anything else. In reality in most western countries the protocols are probably pretty much identical.
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Old 05-06-2012, 04:11 AM   #3
jpm
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Quote:
Originally Posted by Pate View Post
It could be available sooner in Asian countries because there is less red tape and fewer administration issues standing in the way of getting them approved.

The FDA is sort of the benchmark for two reasons, firstly the US is the biggest single target market (though the combined EU is probably now bigger) and secondly the FDA protocols are pretty strict. I think this partly came out of the thalidomide scare in the 1950s. The US never approved thalidomide for sale but it was a near-run thing, and the US and world in general learned about the importance of proper clinical trials from what happened with thalidomide.

In most other countries there is a similar organisation to the FDA, but if a company comes to them and can point to their product having received FDA approval, it will probably be easier for them to get approval in those other countries.

It's more practicality than anything else. In reality in most western countries the protocols are probably pretty much identical.
Cheers Pate! Very informative. What about the EU are treatments there generally release before or after the US?
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Old 05-06-2012, 07:11 PM   #4
Pate
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It depends if the treatment is European or American. From what I can tell there are treatments like Eucapil which are developed in the EU and marketed there but they aren't available in the US due to the fact the regulatory requirements don't dove-tail exactly.

For Eucapil the problem (by my understanding) is that in the EU they are allowed to market it at a cosmetic level, whereas in the US they would require full FDA drug approval to market it. So it's available in the EU but not in the US.

That's what I mean about the FDA requirements being more rigorous.

If it's developed in the US then it will generally pass EU requirements at the same time so it's just a matter of paperwork rather than a full new set of clinical trials.
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Old 05-06-2012, 07:49 PM   #5
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UK is a paranoid red tape socialist nightmare - it takes 621 days to go from recruitment of a candidate to them actually partaking in the clinical trial for say a cancer threapy on the National Health Service, thats going from filling in a form to actually beginning the first day of the trial.... 621 days. The biggest issues impacting progression in the medical field is red tape & OUTDATED SCIENCE.
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