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Studies for Seniors »

By: Clinical Trials of Texas, Inc.

Ever take a minute to think about the process your daily medications had to go through in order to get to your local pharmacy? You may be surprised.

Most medications take a minimum of 12 years to hit store shelves. And that’s if the medication makes it that far. Only about 5 out of 5,000 drugs actually make it to market.

So why does it take so long?

All medications once created, go through pre-clinical testing meaning that the pharmaceutical company conducts its own testing before ever being tested in the human population. This takes about 2-3 years to complete. Once the testing has been completed and results are satisfactory, the drug goes to the FDA for approval to begin testing in humans.If approved, the medication then goes through several phases of testing, which you may be familiar with.

Phase I studies are the first tests done on a specific drug in healthy volunteers. This phase is testing safety of the drug and is usually only done on very small groups of people. This phase takes about a year to complete.

Phase II studies are done on a slightly larger scale and are almost always conducted on volunteers that have the certain condition that the medication is made for. This phase generally takes about 2 years to complete and is used to determine the minimum and maximum effective dose.

Phase III studies are done to show safety and effectiveness of a proposed medication and are typically conducted on thousands of people. This phase takes about 3 years to complete. Once this phase is completed and the pharmaceutical company finds that the medication is effective, they will file a new drug application (NDA) wtih the FDA. It usually takes about 2 and a half years for the FDA to complete their review.

The final phase of testing, Phase IV, is done to test the ongoing safety and effectiveness of a medication after it has been FDA approved.

Phew! Now that’s a long time.

The good news is that because people like you volunteer to be in research studies, we are able to have many of the life-saving medications we have today. Want to know more about the benefits of participating in research? Click here.