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Clinical Trials

Why Participate in a Clinical Trial? What Else Should I Know?

There are many reasons why people choose to join a clinical trial. Some join a trial because the treatments they have tried for their health problem did not work. Others participate because there is no treatment for their health problem. By being part of a clinical trial, participants may find out about new treatments before they are widely available. Some studies are designed for, or include, people who are healthy but want to help find ways to prevent a disease that may be common in their family.Older couple posing with their grandson

Many people say participating in a clinical trial is a way to play a more active role in their own health care. Other people say they want to help researchers learn more about certain health problems. Whatever the motivation, when you choose to participate in a clinical trial, you become a partner in scientific discovery. And, your contribution can help future generations lead healthier lives. Major medical breakthroughs could not happen without the generosity of clinical trial participants—young and old.

Here’s what happens in a trial:

  1. Study staff explain the trial in detail and gather more information about you.
  2. Once you have had all your questions answered and agree to participate, you sign an informed consent form.
  3. You are screened to make sure you qualify for the trial.
  4. If accepted into the trial, you schedule a first visit (called the “baseline” visit). The researchers conduct cognitive and/or physical tests during this visit.
  5. You are randomly assigned to a treatment or control group.
  6. You and your family members follow the trial procedures and report any issues or concerns to researchers.
  7. You may visit the research site at regularly scheduled times for new cognitive, physical, or other evaluations and discussions with staff. At these visits, the research team collects information about effects of the intervention and your safety and well-being.
  8. You continue to see your regular physician for usual health care throughout the study.

Where Can I Find a Clinical Trial?

There are many ways you can get help to find a clinical trial. You can talk to your doctor or other health care provider. Or, you can search www.ClinicalTrials.gov. Support groups with a focus on a particular condition sometimes have lists of clinical studies. Also, newspapers in large cities may have advertisements for clinical trials at nearby hospitals, clinics, or universities.

Learn more about participating in Alzheimer’s disease and related dementias clinical trials and research.

What Is the Next Step After I Find a Clinical Trial?

Once you find a study that you might want to join, contact the clinical trial or study coordinator. You can usually find this contact information in the description of the study. The first step is a screening appointment to see if you qualify to participate. This appointment also gives you a chance to ask your questions about the study.

Let your doctor know that you are thinking about joining a clinical trial. He or she may want to talk to the research team about your health to make sure the study is safe for you and to coordinate your care while you are in the study.

How Do Researchers Decide Who Will Participate?

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After you consent, you will be screened by clinical staff to see if you meet the criteria to participate in the trial or if anything would exclude you. The screening may involve cognitive and physical tests.

Inclusion criteria for a trial might include age, stage of disease, gender, genetic profile, family history, and whether or not you have a study partner who can accompany you to future visits. Exclusion criteria might include factors such as specific health conditions or medications that could interfere with the treatment being tested.

Many volunteers must be screened to find enough people for a study. Generally, you can participate in only one trial or study at a time. Different trials have different criteria, so being excluded from one trial does not necessarily mean exclusion from another.

Also see Questions to Ask Before Participating in a Clinical Trial.

For More Information About Participating in Clinical Trials

ClinicalTrials.gov
www.clinicaltrials.gov 

U.S. Food and Drug Administration
1-888-463-6332 (toll-free)
druginfo@fda.hhs.gov
www.fda.gov