What is a clinical trial?
In order to understand what a clinical trial is, one must understand how medications are developed. Pharmaceutical companies employ teams of scientists to develop and research new compounds to treat an array of diseases and conditions. After the initial laboratory testing is complete and the new compound has passed preliminary safety and efficacy testing in the lab, the pharmaceutical company files an application to the FDA to begin Phase I clinical trials. The average time a new medication takes from the beginning of a Phase I trial to FDA approval is approximately 12 to 14 years.

A clinical trial is the process by which pharmaceutical companies test the safety and efficacy of new medications. There are four phases to every clinical trial:

Phase I.
The new medication is given to healthy individuals who do not have the condition the new medication is intended to treat. These are usually small studies, fewer than 100 patients. This is also the phase in which the initial safety data gets collected.

Phase II.
This is the phase when the new medication is first introduced to patients who have the condition the medication is intended to treat, and also when preliminary efficacy data is collected. During this phase safety data continues to be collected, and changes to dosages are made.

Phase III.
This is the last phase before a medication is presented to the FDA for approval. Phase III clinical trials are usually large trials that often enroll thousands of patients in several states and even in other countries. This phase is also when efficacy and safety of the medication are established.

Phase IV.
Also called “after-market trials,” these trials are conducted after a medication has received FDA approval and is available to the public. FDA requires pharmaceutical companies to continue monitoring their medications even after they have received approval.

Why are clinical trials important?
Clinical trials are important because they are the only vehicle by which any medication will ever become available to the general public. Every single medication, whether it is over the counter or available by prescription, must go through the clinical trial process. But perhaps the best way to describe the importance of clinical trials is by asking the following question: Have you ever taken a medication to treat any condition? If you answer “yes,” then you should thank the thousands of participants who volunteer for clinical trials so that medications become available to the rest of us.

Who sponsors a clinical trial?
Most clinical trials are sponsored by pharmaceutical companies; however, some trials are sponsored by government agencies such as the National Institute of Aging and the National Institute of Health. In some cases, clinical trials are a collaborative effort between pharmaceutical companies and government agencies.

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