Understanding Clinical Trials

Myth: Trial volunteers are guinea pigs

Volunteers are not guinea pigs, but rather very much protected during their time in a clinical trial. There are ethical and legal codes that are followed, built in safeguards to protect volunteers and a carefully controlled protocol that doctors adhere to. We will be talking more about these details later in the education program, as well as common misconceptions about funding, safety and how a clinical trial may or may not help you.

But first, let’s understand some of the basics about clinical trials!

What is a clinical trial?

A clinical trial is a research study that determines whether new treatments are safe and effective for humans. Clinical trials are strictly controlled to ensure the safety of the people taking part.

Who comes up with clinical trials?

Ideas for clinical trials usually come from researchers. After researchers test new therapies in the laboratory and in animal studies, the treatments with the most promising results are moved into clinical trials. During a trial, more and more information is gained about a new treatment, its risks and how well it may or may not work.

What are the phases of clinical trials?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

• In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
• In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
• In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
• In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.