Frequently Asked Questions
What is a clinical study?
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.
What is the purpose of a clinical study?
Clinical studies evaluate a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people.
How do I participate in a clinical study?
You can sign up for a COVID vaccine study here, and any of our other studies here. You will then enter personal details, including whether or not you have participated in a trial before and any medications that you are currently taking.
Anyone who is at least 18-years-old, generally healthy, and well-managed on medications may be eligible to participate.
What is the process like for a participant?
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.
How long will I be in the study?
Patients will be monitored 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.
Questions on safety:
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.
What other risks are there?
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.
Can I get COVID from the vaccine?
No. None of the vaccines will infect you with COVID-19. We also won’t expose you to or give you COVID-19 after the vaccinations. The vaccines being tested are made from synthetic (laboratory made) pieces copied from SARS-CoV-2, not the whole virus. Therefore, the vaccines CANNOT cause infection or cause you to get COVID-19 illness.
Will I experience side effects?
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.
What happens if I start to feel sick?
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. If you require further care, we will direct you to the appropriate medical facility.
What does the “phase” of clinical trial mean and what phase are we in?
Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects.
The clinical trials in Nashville are currently in Phase 3.
A Phase I trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage.
A Phase II trial uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years.
A Phase III trial gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. In this trial, more than 30,000 patients are being enrolled. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.
A Phase IV trial for drugs or devices takes place after the FDA approves their use. A device or drug’s effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.
What are my rights as a participant in the clinical trial?
The Clinical Center Patients’ Bill of Rights developed by the United States Department of Health and Human Services protects you when you volunteer to participate in clinical research as a patient or as a healthy subject. We believe that concern for every research volunteer is linked closely to the successful conduct of clinical research. The Clinical Center provides hospital facilities and professional care; you, the research participant, make it possible for us to observe health and disease and to measure response to treatment.
Your rights and safety are protected by procedures that provide an awareness of your medical choices, of any risks or benefits, and of possible consequences of participating in research. The list summarizes your rights as a research participant at the Clinical Center.
The rights are:
• To safe, considerate and respectful care, provided in a manner consistent with your beliefs;
• To expect that all communications and records pertaining to your care will be treated as confidential to the extent permitted by law;
• To know the physician responsible for coordinating your care at the Clinical Center;
• To receive complete information about diagnosis, treatment, and prognosis from the physician, in terms that are easily understood. If it is medically inadvisable to give such information to you, it will be given to a legally authorized representative;
• To receive information necessary for you to give informed consent prior to any procedure or treatment, including a description of the procedure or treatment, any potential risks or benefits, the probable duration of any incapacitation, and any alternatives. Exceptions will be made in the case of an emergency;
• To receive routine services when hospitalized at the Clinical Center in connection with your protocol. Complicating chronic conditions will be noted, reported to you, and treated as necessary without the assumption of long-term responsibility for their management;
• To know in advance what appointment times and physicians are available and where to go for continuity of care provided by the Clinical Center;
• To receive appropriate assessment of ,and treatment for, pain;
• To refuse to participate in research, to refuse treatment to the extent permitted by law, and to be informed of the medical consequences of these actions, including possible dismissal from the study and discharge from the Clinical Center. If discharge would jeopardize your health, you have the right to remain under Clinical Center care until discharge or transfer is medically advisable;
• To be transferred to another facility when your participation in the Clinical Center study is terminated;
• To expect that a medical summary from the Clinical Center will be sent to your referring physician;
• To designate additional physicians or organizations at any time to receive medical updates.
The medical community has formed additional rules for conducting research on humans. These include:
• Nuremburg Code, August 9, 1947
• Declaration of Helsinki, June 1964 – seven revisions since
• Belmont Report, 30 September 1978
What are the benefits of participating in a clinical trial?
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.