Patient care not accounted for in FDA

In a recent blog post by Erik Greb, he addresses the current unmet needs of patients when participating in clinical trials. The Department of Health and Human Services is proposing that personnel who conduct, review and oversee clinical trials with humans should be trained.

Greb was surprised that this need was not already met, and took time to inform us of other standards that are not set for clinical trials. According to Erik’s post the following are not standards when it comes to clinical trials:

-The training mentioned above is not formalized
-The FDA does not know how many people are currently in clinical trials in the United States
-The FDA has only inspected 1% of clinical trials sites