What Comes After Phase III?
If you answered "Phase IV," you're sorta right.
In most cases, the results of a large Phase III trial are submitted to the Food and Drug Administration with all other available information by the sponsor of the drug or device being tested. The FDA considers all of the data and makes a determination regarding approval of the product for marketing.
For a number of reasons, it may be determined that further data are desired. Perhaps the sponsor would like to make a particular advertising claim about the product, but the existing data, while proving the safety and effectiveness of the product to the satisfaction of the FDA, do not fully support the claim. So the sponsor may decide to conduct another clinical trial to specifically demonstrate some feature of the product so that future advertising may include the claim, leading to increased sales. Such additional clinical research is sometimes referred to as Phase IV research.
Similarly, the sponsor may wish to carefully measure certain side effects of the product in wide use. In such a case, a Phase IV trial is conducted following the initial introduction of the product to the market. Also known as "Post-Marketing" studies, Phase IV data are also sometimes used to suggest improvements to be made in a product.
Whatever the motivation, all of the rules for Phase IV clinical trials are the same as for Phase I, II and III research. Participation is voluntary. And the data are collected and analyzed according to predetermined statistical models.
There is a role for Phase IV studies. The defining feature is that they usually occur after a product has entered the market.
-Joe
Related Topics: Sorting Through The Latest Studies, What is a Clinical Trial?
Technorati Tags: clinicaltrials, phase3trial, phase4trials
In most cases, the results of a large Phase III trial are submitted to the Food and Drug Administration with all other available information by the sponsor of the drug or device being tested. The FDA considers all of the data and makes a determination regarding approval of the product for marketing.
For a number of reasons, it may be determined that further data are desired. Perhaps the sponsor would like to make a particular advertising claim about the product, but the existing data, while proving the safety and effectiveness of the product to the satisfaction of the FDA, do not fully support the claim. So the sponsor may decide to conduct another clinical trial to specifically demonstrate some feature of the product so that future advertising may include the claim, leading to increased sales. Such additional clinical research is sometimes referred to as Phase IV research.
Similarly, the sponsor may wish to carefully measure certain side effects of the product in wide use. In such a case, a Phase IV trial is conducted following the initial introduction of the product to the market. Also known as "Post-Marketing" studies, Phase IV data are also sometimes used to suggest improvements to be made in a product.
Whatever the motivation, all of the rules for Phase IV clinical trials are the same as for Phase I, II and III research. Participation is voluntary. And the data are collected and analyzed according to predetermined statistical models.
There is a role for Phase IV studies. The defining feature is that they usually occur after a product has entered the market.
-Joe
Related Topics: Sorting Through The Latest Studies, What is a Clinical Trial?
Technorati Tags: clinicaltrials, phase3trial, phase4trials
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