What’s a Clinical Trial?

Whenever a new chemical substance is discovered that may have some beneficial effect on the human body, it needs first to be developed and tested before it can be used. These substances come from various sources such as plants, but these days most are made synthetically. For every new medicine to make it to market, around 10,000 chemical substances have been examined and of these only about 1,000 make it into animal testing. Then only 5 to 10 of the substances that have been through this stage will go forward to be tested on human beings.

Before human testing can begin, all the pre-screening data has to go before an independent Ethics Committee, who will evaluate and check that it is safe, and not likely to cause harm to volunteers.

A clinical trial is a medical research study to determine the safety and effectiveness of a new chemical or treatment and discover any side effects. Clinical trials use humans; pre-clinical trials use animals.

The drug or treatment under investigation in the clinical trial may be:

• new and never been tested on people before
• an existing one being used in a new way

In some clinical trials, a new drug or treatment may be compared with the best-known standard therapy to see if it is more effective or causes fewer side effects.

Information from clinical trials is essential to new drug approvals and refining the proper use of existing treatments and medications. Without human volunteer testing, new drugs and treatments could not make it to market.