A clinical trial (also known as a clinical study) is a research project in which interventions are measured in human subjects to evaluate the effects on health-related outcomes. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.

Before the U.S. Food and Drug Administration (FDA) approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans.

There are many reasons why people choose to join a clinical trial. 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.

Researchers and the FDA have determined that the vaccine is safe enough to be tested in human patients. Protecting the safety and human rights of clinical trial patients is universally recognized as the critical requirement to the ethical conduct of research involving human subjects. Researchers are required to follow strict rules to make sure that participants are safe. At Clinical Research Associates, we have a dedicated and compassionate medical staff including doctors, nurses, and dieticians who closely monitor and respond to the health and well-being of trial participants.

Although efforts are made to control risks to clinical trial participants, some risk may be unavoidable because of the uncertainty inherent in clinical research involving new medical products. It’s important that people make their decision to participate only after they have a full understanding of the entire process and the risks that may be involved.

You can learn more about any of our current studies here. 

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.

Studies can last from just a few weeks to a few years. Our recent COVID vaccine studies will last for two years following the initial dosage, and will check in with study administrators at pre-determined times through in-person visits, over the phone, or through a study-specific app. The two-year duration is to study the efficacy and safety of the vaccine over time.

You might experience short-term side effects, similar to those from any vaccination, such as arm soreness or feeling tired or unwell. Since these are the first studies of the vaccines in people, there may be risks or side effects that are not known. We will discuss potential side effects with you before you enroll.

If you feel sick, you should immediately get in touch with our staff to schedule an illness visit. Our medical staff will provide you with care and collect biomedical samples.

1. You can stop taking part in the trial at any time. It is up to you.

2. If you want to stop participating at any point, you can let the study site staff know. 

Most clinical trials will not allow patients to participate in more than one trial at once. This is so that doctors and researchers can measure the results of only one medicine at a time. That way, they will know if positive results or side effects are the result of a single medicine, and not an uncommon combination of two unrelated treatments. Although researchers will sometimes combine medicines into one study, this is less common than studying one medicine at a time.