DRUG TRIALS MORE TRANSPARENT

DRUG APPROVAL GETTING TIGHTER

The United States (US) Food and Drug Administration (FDA) approves new drugs based on sponsor-submitted clinical trials. 

Over half of all supporting trials for FDA-approved drugs remained unpublished more than 5 years after approval.   Selective reporting of trial results exists for commonly marketed drugs.

Before a new drug becomes available for the treatment of a specific human disease, its benefits and harms are carefully studied,  Trials are done first in the laboratory and in animals, and later in clinical trials.

The efficacy and safety of the new drug are compared to present day treatment. These outcomes indicate whether the new drug is more effective than the standard treatment .

After a drug receives FDA approval, information about the clinical trials supporting the FDA's decision is included in the FDA “Summary Basis of Approval”.

In addition, some clinical trials are described in medical journals. Ideally, all the clinical information that leads to a drug's approval should be publicly available to help clinicians make informed decisions about how to treat their patients.

 A full-length publication in a medical journal is the primary way that clinical trial results are communicated to the scientific community and the public.

Unfortunately, drug sponsors publish the results only of trials where their drug performed well. And the drug companies selectively reported on drug trials that had good results.  When the drug did no better than the standard treatment or had side effects it never got unpublished.

Seventy six percent of the pivotal trials did appear in medical journals, but only3 years after the drug had already received FDA approval. In addition, only 43% of all of the submitted trials were ever published.

More than half the clinical trials undertaken to support drug approval remain unpublished  5 or more years after the drug got FDA approval. 

This is where we stand now in monitoring the effects of the FDA Amendments Act 2007, which was introduced to improve the accuracy and completeness of drug trial reporting.

 Under this Act, all trials seeking FDA-approval must be registered when they start, and the results and details must be publicly posted within a year of drug approval on the US National Institutes of Health clinical trials site.

Sounds like a good start with this overseeing institution.  Lets hope the drug companies cooperate.  Perhaps fewer drugs will be approved that compromise the safety of the public.

Source:  Public library of science Sept. 08 www.PLoSMedicine.com

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