What are clinical trials?

Clinical trials study potential new treatments in health volunteers and/or people with a specific illness or condition. These treatments already have had some positive effects on a disease in lab or animal experiments. Clinical trials are the next step in the drug development process to see if a treatment generally safe and effective in people.

Different phases in clinical development

It takes a lot of research to develop a new treatment. Clinical trials are done in several steps, also called “phases”. Each phase has a specific purpose, such as to look at how well the treatment or drug works, what is the best dose and what side effects may occur.

PC

Before clinical trials can be done with human participants, researchers study new treatments in the lab. This is called “pre-clinical development”. Once the researchers have enough information, they ask for permission to do clinical trials from the health authority and independent groups called ethics committees.

PHASE

I

Phase 1 trials are usually the first time a new treatment is studied in humans. These studies are typically conducted on small populations of healthy humans to learn what the body does to a drug, such as how it is absorbed, processed and how it passes out of the body.

PHASE

II

After the successful completion of Phase 1 trials, Phase 2 trials are done in a slightly larger population to learn if a new treatment helps people who have the disease or condition for which the treatment was developed. These trials are also designed to keep learning about side effects people have while using a treatment.

PHASE

III

Phase 3 trials are done to confirm that a new treatment helps people who have the disease or condition for which the treatment was developed. They are designed to learn how a treatment works compared to the standard therapy currently being used for the disease or compared to a “placebo”. A “placebo” is designed to resemble the treatment but does not have any real effect. These trials are also designed to keep learning about side effects people have while using a treatment. The results of these trials usually provide the information that is included in the package insert and labelling.

PHASE

IV

Phase 4 trials are done after a treatment has been approved for all people to use. These trials take place over many years. They are done to learn how a treatment works when people are taking it as part of their everyday lives. Sometimes these trials are “observational” studies. The people in observational studies are prescribed the treatment in the usual manner. They are not assigned to a treatment by the researchers.

Frequently asked questions

Participate in a Bayer trial

Bayer clinical trials study a new treatment’s safety or how well it helps people with a disease/condition. The treatment may be a drug, medical device, or new way of using an existing treatment. You can volunteer to participate in a clinical trial.

Find a Bayer trial that might be right for you.