Asia as the bed for new clinical trials -- whither accountability?
[Cross posted from my medical devices and biotechnology blog]
[Click on title for link to original article]
So, now Asia is trying to take over expensive clinical trials. But these clinical trials are usually expensive for a reason. The trials have to be well planned out, the IRBs have to be written out properly, and there are a host of other procedures that ensure one thing does not happen - fraud.
What could fraud in a clinical trial lead to? Death, of innocent humans for one. Fabrication of results for another. And then, there are a hundred other things that can happen.
Do we assume that just because the FDA exists, or because the companies will be outside the purview of the FDA, fraud does not happen?
We do not say that, but assume that a country decides to subsidize for the sake of clinical trials. How wary of lawsuits and complaints of unfair play is this country going to be?
These are yet unanswered questions, that need to be carefully examined. One would rather wait and see stringent laws and norms in place, before gladly accepting that the companies would self - regulate themselves.
I would rather wait till India has good laws, before it jumps onto this bandwagon. Especially since it was discovered that certain Ayurvedic pharmaceuticals which were being exported to the US had heavy metals in them, I have been wary of the status of the law surrounding drugs in India. One needs to watch out for these.
Another unanswered question - how many of these clinical trial results obtained in Asia will be accepted by the FDA or the European/Japanese regulatory agencies?
[Click on title for link to original article]
So, now Asia is trying to take over expensive clinical trials. But these clinical trials are usually expensive for a reason. The trials have to be well planned out, the IRBs have to be written out properly, and there are a host of other procedures that ensure one thing does not happen - fraud.
What could fraud in a clinical trial lead to? Death, of innocent humans for one. Fabrication of results for another. And then, there are a hundred other things that can happen.
Do we assume that just because the FDA exists, or because the companies will be outside the purview of the FDA, fraud does not happen?
We do not say that, but assume that a country decides to subsidize for the sake of clinical trials. How wary of lawsuits and complaints of unfair play is this country going to be?
These are yet unanswered questions, that need to be carefully examined. One would rather wait and see stringent laws and norms in place, before gladly accepting that the companies would self - regulate themselves.
I would rather wait till India has good laws, before it jumps onto this bandwagon. Especially since it was discovered that certain Ayurvedic pharmaceuticals which were being exported to the US had heavy metals in them, I have been wary of the status of the law surrounding drugs in India. One needs to watch out for these.
Another unanswered question - how many of these clinical trial results obtained in Asia will be accepted by the FDA or the European/Japanese regulatory agencies?
posted by Srihari Yamanoor at 11:53 AM
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