FDA on conflicts of interest in clinical trials.(Medication Update)

As medications grow in importance in the treatment of addictions, the Food and Drug Administration (FDA) is overseeing the regulatory process for more of these drugs in pharmaceutical "pipelines," as the drug development process is called. Because the clinical trials that evaluate the effectiveness and safety of drugs are increasingly paid for by the drug "sponsor" (pharmaceutical company)--and less often by the federal government (National Institutes of Health, typically)--there have been significant concerns about conflicts of interest in the process, especially in the area of psychiatric drugs. The FDA has issued rules about disclosure of conflicts by researchers so sponsors can address potential bias with studies as they are being designed.

"Proper study design includes blinding, randomization, and objective endpoints," said FDA spokesman Jeffrey Ventura in an email on the topic this month. "Other tools to minimize and eliminate bias include third …