Most of us believe that prescription drugs are tested for safety. And we believe that theses tests are reviewed and drugs which are not safe are not prescribed. Yet, according to a recent review of over 900 clinical drug trials, most failed clinical trials are never published. In fact, more than half the studies showing a drug was ineffective were never published.
Sponsors seek approval by submitting a new drug application (NDA) to the Food and Drug Administration (FDA). The application includes information about the ingredients, pharmacology, manufacturing, processing, and packaging of the drug. It also includes clinical trial information.
The FDA assumes that sponsors submit all data, including data from failed trials, so that the FDA can decide whether to approve the drug based on the sponsor´s conclusion that it is safe and effective. However, this is not the case according to a recent study.