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 Phases / steps followed in conducting clinical trials Minimize

New medicines or devices are studied in great detail (extensively) over a long period, in the laboratory and in various animals to establish its initial safety and effectiveness. Trials or testing of medicines and/or devices in people only takes place after they have been tested thoroughly in the laboratory on animal studies. The testing of investigational (new) drugs, vaccines and medical devices in humans usually follows a process that can be broken up into four phases or steps. These are described below:

 

Phase 1: During this first phase a new drug, vaccine or medical device is tested in a small group of usually healthy persons for the very first time. In the Phase I clinical trials the aims are to determine the general safety, the correct dosage and possible negative or undesirable effects of the new drug, vaccine or medical device.

 

Phase II: In Phase II clinical trials the new drug, vaccine or medical device is tested in a larger group (several hundred healthy people). At this stage people with the disease for which the new drug, vaccine or medical device is developed are also given the opportunity to participate in testing it. The purpose of phase II is to further test the safety and effectiveness of the new drug, vaccine or medical device.

 

Phase III: During this phase, the new drug, vaccine or medical device is tested in a larger group (several hundred to few thousand) of people who suffer from the disease/illness for which the new drug, vaccine or medical device is intended. The effectiveness and possible undesirable effects are evaluated in more depth during this phase. The new drug, vaccine or medical device is compared to old registered (licensed) drugs, vaccines or medical devices, or alternative treatment options.

 

Phase IV: Clinical trials in this phase are done after the new drug, vaccine or medical device has been registered and licensed for sale by the Medicines Control Council (MCC). During phase IV the drug, vaccine or medical device is tested in several thousand people to: define its safety, effectiveness, long-term undesirable effects, test the new drug, vaccine or medical device in certain high risk sectors of the population like children, the elderly, people with liver and kidney diseases, and find new uses (indications) of the new drug, vaccine or medical device.

 

Each phase has its specific purposes and the potential for benefits, risks and harms may vary with each phase.

  

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