Drug Policy Question of the Week – 5-28-11
As answered by Mary Jane Borden, Editor of Drug War Facts for the Drug Truth Network on 5-28-11. http://www.drugtruth.net/cms/node/3403
Question of the Week: What are Clinical Trials?
Wikipedia defines clinical trials as,
“a set of procedures in medical research conducted to allow safety and efficacy data to be collected for health interventions such as drugs, diagnostics, devices, and therapy protocols.”
Clinical trials in the United States begin with the Food and Drug Administration or FDA that
“regulates both the safety and effectiveness of prescription pharmaceuticals and certain medical devices.”
The National Bureau of Economic Research overviews this process that,
“begins when a firm files an Investigational New Drug [IND] application, which requests permission from the FDA to conduct clinical trials on humans … Once the FDA gives its approval, the firm may begin conducting clinical trials for the drug, which proceed in three phases.”
“The goal of Phase I is to evaluate the drug’s safety and to obtain data on its pharmacologic properties. Typically, phase I trials enroll small numbers of healthy volunteers. Phase II trials then enroll slightly larger numbers of sick volunteers. The goal of these trials is to begin investigating a drug’s efficacy and optimal dosage, and to monitor the drug’s safety in diseased patents. Finally, Phase III testing typically involves larger numbers of sick patients and is the most costly stage of the approval process. Phase III testing seeks to establish more definitively the efficacy of a drug, as well as to discover any rare side effects. Upon the completion of Phase III testing, the firm submits a New Drug Application to the FDA, which is accompanied by the results of the clinical trials. The FDA may then reject the application, require further clinical testing, or approve the drug outright.”
These facts and others like them can be found Regulation of Prescription Drugs section of the United States Chapter of Drug War Facts at www.drugwarfacts.org.