Drugs and Medical Devices Regulatory Agencies
If a clinical trial concerns a new regulated drug or medical device, or an existing drug for a new purpose, the appropriate regulatory agency for each country where the manufacturer wishes to sell the drug or device is supposed to review all study data before allowing the drug or device to proceed to the next phase, or to be marketed. However, if the manufacturer or sponsor withholds negative data, or misrepresents data it has acquired from clinical trials, the regulatory agency may make the wrong decision.
In the United States the Food and Drug Administration can audit the files of local site investigators after they have finished participating in a clinical trial, to see if they were correctly following the required procedures. This audit may be random, or for cause (because the investigator is suspected of fraudulent data). Avoiding an audit is an incentive for investigators to follow study procedures.
Different countries have different regulatory requirements and enforcement abilities. An estimated 40 percent of all clinical trials now take place in Asia, Eastern Europe, central and south America. “There is no compulsory registration system for clinical trials in these countries and many do not follow European directives in their operations”, says Dr. Jacob Sijtsma of the Netherlands-based WEMOS, an advocacy health organisation tracking clinical trials in developing countries."
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