The process of obtaining approval for a new medication takes years. Clinical trials are one of the most important steps in the approval process.
Phases and Questions
What Is a Clinical Trial?
A clinical trial is a series of research studies in which people 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 trial. Most clinical trials look at a specific illness; however, many evaluate new medical procedures or even preventive measures.
- Before a clinical trial can begin with humans, it is first tested extensively in the laboratory and in animals.
- Clinical trials are carefully supervised, monitored, and documented. The applicable regulatory authority must grant approval to conduct testing in humans, and clinical trials are overseen by an independent review body.
Why is it important to participate in a clinical trial?
Participating in a clinical trial can sometimes have an impact on a person’s daily routine, and there is no guarantee that the treatment will work.
However, clinical trial volunteers play a critical role in determining whether new drugs are safe and effective. In the case of hereditary illnesses, effective medications can help not only this generation, but generations to come. Without a large pool of participants, it takes far longer to get drugs approved and, to bring life-saving treatments to those who need them.
How are clinical trials conducted?
ERIB conducts clinical trials in accordance with International Conference on Harmonisation Good Clinical Practice (ICH GCP) standards, the Declaration of Helsinki and the local laws of the country in which the clinical trial is conducted.
Learn more about clinical trials and learn how to enroll.