
WHY PARTICIPATE IN A CLINICAL TRIAL?
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, such as one that may be common in their family.
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:
- Study staff explain the trial in detail and gather more information about you.
- Once you have had all your questions answered, agree to participate, and before any testing is performed, you sign an ethics approved informed consent form. You are screened to make sure you qualify for the trial. 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, sex, 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.
- 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.
- You are randomly assigned to a treatment or control group.
- You (and if appropriate your family members) follow the trial procedures and report any issues or concerns to researchers. These will be recorded in a dairy to be time stamped and any adverse event specifically documented. These diary cards will be collected at the end of the study and entered into the online data portal for collation and evaluation.
- You may visit the research site at regularly scheduled times for new vision (cognitive), physiological, 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.
- You continue to see your regular physician for usual health care throughout the study. If you feel that it is appropriate, 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.