About Clinical Research Trials

The process of obtaining approval for a new medication takes years. One of the most important steps in the approval process are the clinical research trials.

What Is a Clinical Research Trial?

A clinical research trial is a series of research studies in which people like you volunteer to receive a treatment (such as a drug) and be observed for its effects — both in terms of its safety and its effectiveness.

• Any type of treatment can be tested in a clinical research trial. Most clinical research trials look at a specific illness; however, many evaluate new medical procedures or even preventive measures.
• Before a clinical research trial can begin with humans, it is first tested extensively in the laboratory and in animals.
• Clinical research trials are carefully supervised, monitored, and documented. The US Food and Drug Administration (FDA) must grant approval to conduct testing in humans, and clinical research trials are overseen by an independent organization called the Investigational Review Board (IRB).

Why is it so important to participate in a clinical research trial?

Participating in a clinical research trial can sometimes have an impact on a person's daily routine, and there is no guarantee that the treatment will work.

However, clinical research trial volunteers play a critical role in determining whether new drugs are safe and effective. In the case of hereditary illnesses, such as HAE, effective medications can help not only this generation, but generations to come. Without a large pool of volunteers, it takes far longer to get drugs approved and, to bring life-saving treatments to those who need them.

Learn more about clinical research trials and find out what is involved in enrolling in a clinical research trial.