Drug Safety Data from Clinical Trials
It use to be that major pharma companies did not want to share safety data from clinical trials because they considered the information proprietary.
PharmaLive: Taking the Wraps Off Drug Safety Data from Clinical Trials :
There has been much talk recently about changing that. Some companies have said they will start their own database however, having many different database with differing information I don’t feel would be productive. I also don’t think a voluntary program run by a pharma group would be the best solution either. I’m not sure what is the best but think that in the next five to six years you will see some sort of database covering multiple companies.
Here are some recommendations from the article in Health Affairs in the March/April 2007 issue. The authors are Dr. Aaron Kesselheim and Michelle Mello.
Placing a heavier burden of proof on companies to show competitive harm if data are released.
Replacing the current Summary Basis of Approval with a more comprehensive public document that includes all safety data.
Getting Congress to pass legislation requiring public disclosure of safety data if the FDA fails to take action.
“Safety data from drug clinical trials have important ramifications for public health,” said Kesselheim. “The government should do as much as it can to ensure full disclosure of the information.”
I personally think it will take action from Congress before anything concrete will happen.
Technorati Tags: clinical trials, drug development, drug safety
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