About Clinical Trials

Researchers conduct clinical trials to learn whether an intervention or experimental treatment works and is safe for people with specific conditions before it can be approved for use by the general population or those diagnosed with a specific disease.

“Children are not just small adults – their bodies work in very different ways and they often undergo many changes as they grow from infancy towards adolescence and adulthood. Because their bodies work differently, it’s important to create child-specific medicines and treatments instead of just modifying adult doses and therapies.”

- Clinical trials in children - World Health Organization

Phases of a clinical trial

Clinical trials are done in several steps, which are also called “phases." Each phase is designed to answer specific questions about the experimental treatment to see if it works and to understand what side effects may occur. As an experimental treatment moves through these phases, researches learn more about the treatment, its risks and its effectiveness.

Pre-Clinical Development
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Before clinical trials can involve people like you, the experimental treatment may need to be researched in the lab. Once the researchers have enough information, they ask for permission from the government and independent groups called ethics committees to begin clinical trials.
Phase 1
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These clinical trials are usually the first time an experimental treatment is studied in a small group of people. Phase 1 trials may study an experimental treatment in healthy volunteers. They may also research the late stage of diseases, like cancer where standard treatments are no longer effective. Phase 1 trials help researchers test the safety of a treatment and determine a safe dose or range of doses to be used in the next phase. Researchers also find out how the treatment acts in the body and may identify side effects people have when using the experimental treatment.
Phase 2
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These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials. Researchers continue to study the safety of the experimental treatment. If the treatment is an experimental drug, researchers continue to learn about which dose works.
Phase 3
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These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo. A placebo looks like a drug or treatment but does not have an active product or treatment in it. Using a placebo without another active treatment may not be appropriate in some conditions or diseases. In phase 3 clinical trials researchers also continue to study the safety of the treatment. After Phase 3, researchers share all the information learned from all phases of clinical trials with government regulatory agencies, such as the United States Food and Drug Administration, European Medicines Agency, or Pharmaceuticals and Medical Devices Agency in Japan. Based on the information, these agencies decide if a treatment can be approved for patients to take.
Phase 4
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These clinical trials happen after a drug or treatment has been approved for patients to take. Clinical trials in phase 4 usually take place over many years because researchers want to learn about long term use and safety of a drug or treatment. Researchers may also look at other aspects of the treatment after it is approved, such as impact on quality of life. Phase 4 clinical trials usually include thousands of participants.
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Why participate in a clinical trial?

You don’t have to be a doctor, scientist, or researcher to play a part in advancing medicine. You can be a clinical trial participant, even if you do not have a medical illness. Many clinical trials include healthy volunteers.

The reasons for joining a clinical trial are personal, and as different as the conditions or diseases being studied. Here are a few common reasons why people participate in clinical trials. You may find some that you can relate to, or you may have other reasons for participating.

Access experimental treatments and care
As a clinical trial participant, you may have access to experimental treatments before they are widely available. In addition, participation in a clinical trial provides an opportunity for you to play an active role in your own healthcare.
Help others by advancing medical science
Your participation helps researchers gather important information that may guide future research. When you participate, you are helping researchers learn of new ways to manage, treat or monitor a disease or condition.
Help researchers discover new treatments
What researchers learn from clinical trials helps them discover new or better treatments or tests that may help future patients.

It is important to note that participants in a clinical trial may or may not benefit from their participation. For some people, taking part in a clinical trial is a way to leave a legacy for future generations.

What to expect when participating in a clinical trial

Here are some steps you can expect when you participate in a clinical trial:

  • You will talk to a member of the clinical team to learn about the clinical trial and to see if it may be a good fit for you. A research team member will explain the trial and ask you some questions about your health so you can decide together if the clinical trial is a match for you. This is also a good time to ask questions about participation details. The clinical trial doctor will also explain if participating in a clinical trial may impact other treatment options for your condition or illness.

  • If you are eligible and decide you want to participate in the clinical trial you will need to sign a document called an informed consent form. This document contains information about the clinical trial and possible risks and benefits of being in the clinical trial. It also includes information about what is required from you if you choose to participate. By signing the consent form, you confirm that you understand the information in the form and agree to participate. You can still choose to leave the clinical trial at any time, even after signing this consent form. Withdrawing from a clinical trial would not impact other treatment options available through your doctor.

  • The research team will review your medical history and perform a physical exam and other tests to see if you can participate in the clinical trial. Tests for screening usually include recording your height, weight, temperature, and blood pressure. They often require a collection of samples such as blood and urine. You may also have other types of tests (such as a CT or MRI scan) or measurements done if they are needed for the particular trial.

  • If you meet the clinical trial requirements and choose to participate, you may join the clinical trial. When you enroll, the research team will review what you need to do and how often. You may be given instructions to take home with you.

  • Your clinical trial visits may be days, weeks or months apart. They may be at a clinical trial site such as a doctor’s office, clinic, or hospital, or even at your home. During those visits you may receive treatments and tests. You may be asked to complete questionnaires or perform other procedures to help understand how you feel and how the treatment is working. The clinical trial team may also ask you to do some tasks at home. You will also be asked questions about any health changes or new symptoms, also called adverse events or side effects, you may be experiencing.

  • When you complete the clinical trial treatment or if you stop the trial treatment for any reason, you may be asked to complete an end of treatment assessment. This usually includes an exam and some tests. In some clinical trials, even after all trial treatments are done, additional visits may be needed; or the clinical trial team may follow up with you over the phone to see how you are doing. This allows the researchers to continue monitoring progress and finding out if participants are having any new medical problems.

Find an Astellas Clinical Trial Near You

Search Astellas Clinical Trials to see if any might be a match for you or for someone you care about.