What are Clinical Trials?
A clinical trial is a research study to answer specific questions about a new medical treatment or new ways of using known treatments. Clinical trials (also called medical research or research studies) are used to determine whether new treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Studies are done with patients to find out whether promising approaches to disease prevention, diagnosis, and treatment are safe and effective.
Clinical trials are usually classified into one of four phases:
Phase I Trials are the first studies conducted in humans and evaluate how a new drug should be given, how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
Phase II Trials continue to test the safety of the drug, and begin to evaluate how well the new drug works.
Phase III Trials test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. Phase III trials often enroll large numbers of people.
Phase IV Trials continue to investigate a drug after its initial regulatory approval. In this phase the focus is on further evaluation of the use for which the drug was approved, for comparison to or combination with, other established drugs and to generate more data on safety under broader use. Phase IV trials are an important tool to strengthen the understanding of the drug and to give guidance to prescribers and patients on the safe and appropriate use under various clinical conditions.
View our interactive explanation of Clinical Trials at
Boehringer Ingelheim.
