About Clinical Trials | Astellas Clinical Trials

Clinical trials help find new ways to treat, diagnose, and even prevent disease. They can also find “risk factors” for disease, such as genetic changes or lifestyle habits, that might make someone more likely to get a disease later. In some countries, clinical trials are also called “clinical studies” or “clinical research studies” or simply “trials.”

Before starting clinical trials with people, sponsors first study the investigational treatment in the lab on cells or animals. These are called pre-clinical studies. Sponsors must get approval from government regulatory agencies before studying investigational treatments in people. These agencies look at the results from pre-clinical studies and review the sponsor’s plans for the investigational treatment, to decide if it is okay to start clinical trials.

The 4 Phases of Clinical Trials

Clinical trials happen in several steps, called “phases.” Each phase has a different purpose and helps sponsors answer specific questions about the investigational treatment. As an investigational treatment moves through these phases, sponsors learn more about how safe and effective it is for treating a condition or disease.

Phase 1

Phase 1 trials check if an investigational treatment is safe in a small group of people, usually fewer than 100. They look for common side effects and find the right dose to use in the next phase. Sometimes, they study a treatment in healthy volunteers or in people with the disease when other treatments are not available or not ideal.

Phase 2

Phase 2 trials usually have more participants, up to several hundred people. They still check the treatment’s safety, but they also start to see if it works for people with the disease or condition.

Phase 3

Phase 3 trials collect more information about how safe an investigational treatment is and how well it works. Phase 3 clinical trials usually have many participants, sometimes thousands.

Phase 4

While pre-approval trials check safety and efficacy, many questions remain, especially about long-term use. Phase 4 trials watch larger groups of people of different ages, sexes, ethnicities, and with different health conditions. These trials may find side effects that did not show up in smaller, shorter trials. They also look at how the treatment affects patients’ quality of life.

Learn more about how long each phase of clinical trial lasts

What to expect when deciding to take part in a clinical trial

Joining a clinical trial is your choice, and there are many factors to consider before deciding. Learn more about the steps to join and what to expect after joining.

Prescreening

You will talk to clinical trial staff to learn about the clinical trial and to see if it may be a good fit for you. A clinical trial staff member will explain the clinical trial and ask you some questions about your health. Together, you can decide if the clinical trial is a match for you. This is also a good time to ask questions about what you need to do and how much time it will take. The staff will also tell you if joining the trial may affect other treatment options for your disease or condition.

Complete Informed Consent

If you are eligible and decide you want to join the clinical trial, you will need to sign a document called an informed consent form. This form tells you about the clinical trial and the possible risks and benefits. It also explains what you need to do if you choose to take part. By signing the consent form, you acknowledge that you understand the information and agree to take part. You can still choose to leave the clinical trial at any time, even after signing.

Screening

The clinical trial staff will review your medical history and do a physical exam and other tests to see if you can join. They will measure your height, weight, temperature, and blood pressure. They might also take samples of your blood and urine. Sometimes, you may have other types of tests like a CT or MRI scan, depending on the clinical trial.

Enrollment

If you meet the criteria and choose to take part, you may join the clinical trial. When you enroll, the clinical trial staff will review what you need to do and how often. They may give you instructions to take home with you.

Clinical trial participation

Your clinical trial visits may be days, weeks, or months apart. They may be at a doctor’s office, clinic, hospital, or even at your home. Some clinical trials may also offer virtual visits through telehealth. During these visits you may get treatments and tests. You may need to fill out questionnaires or do other tasks to show how you feel and how the treatment is working. The clinical trial team may also ask you to do some tasks at home. They will also ask questions about any health changes or new symptoms, also called adverse events or side effects. All changes in your health or symptoms must be recorded, even if you and the healthcare team are not sure if they are because of the investigational treatment.

End of treatment

When you finish the clinical trial treatment or if you stop it for any reason, you may need to do an end-of-treatment check-up. This usually means an exam and some tests. The end of your participation is different for each clinical trial. In some trials, you might need more visits even after all clinical trial treatments are done. The clinical trial team may call you to see how you are doing. This allows the sponsors to keep track of your progress and to find out if you are having any new medical problems.

Prescreening

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THE PURPOSE OF THIS WEBSITE IS TO OFFER EDUCATION AND INFORMATION TO PATIENTS AND THEIR FAMILIES AND FRIENDS, THE PUBLIC, AND HEALTHCARE PROFESSIONALS ABOUT THE CLINICAL TRIAL PROCESS. IN ADDITION, THE WEBSITE WILL PROVIDE SPECIFIC INFORMATION ABOUT ASTELLAS CLINICAL TRIALS. PLEASE READ THE COMPLETE ASTELLAS TRANSPARENCY POLICY TO LEARN ABOUT THE CLINICAL TRIAL INFORMATION AVAILABLE ON THIS WEBSITE