FAQs

Clinical trials are the primary way to understand how well a new treatment (like a medicine, diet, or medical device [such as a pacemaker]) works and what side effects it might have.

Clinical trials may look for participants who have a specific disease or disorder, but some also look for healthy participants. Volunteers who match study requirements – such as sex, age, condition, or treatment history – may join a clinical trial. A study team member will screen all volunteers to confirm they meet the trial requirements.

No, you are welcome to contact any ongoing study directly.

If a patient is ineligible, they should check with their healthcare provider to seek other care options.

• Playing a more active role in your own health care.
• Receiving additional study-related check-ups added by researchers.
• Possible early access to an investigational treatment before it is available to the general public.
• Help researchers discover better ways to treat health problems and improve care for others in the future.

A placebo is a treatment that looks like the real one but doesn’t have any active ingredients. It’s not meant to help with the condition, but is used in studies to help researchers see if the real treatment actually works.

Because it looks the same, neither the participant nor the study team knows who is getting the real treatment or the placebo. This helps make the results fair and accurate.

Clinical trials are designed with the highest ethical and safety standards and require the review and approval of numerous review boards, such as an Institutional Review Board (IRB) that ensures the risks are minimal compared to the potential benefit. Clinical Trials conducted in the United States must also adhere to all FDA regulations and Good Clinical Practice standards to ensure clinical trials are safe and ethical.

With this said, participating in a clinical trial may still carry risks, including:

• The inability to choose the intervention you receive, including the dosage level or if you get a placebo, which contains no active drug.
• The investigation intervention might not be better than available interventions.
• There is a chance of experiencing unwanted side effects.
• Participation in a clinical trial may require you to manage complex medication doses, to have additional or longer medical appointments, more procedures, or hospital stays.

Participants are valued and treated with quality care and closely monitored throughout the trial to ensure a patient’s health and safety. Participation is always voluntary, and participants can choose to stop participation in the trial at any time. Anyone thinking about joining a clinical trial must weigh the risks and benefits. It’s important to discuss participation with your doctor so you are fully aware of all considerations.

View this infographic to see suggested questions to help you start the conversation.

During any trial, side effects may occur and identifying them is an important part of the intervention approval process. Your study team will closely monitor any side effects and you always have the option to leave the trial at any time.

All trials have different timelines due to various factors, such as the trial phase, study design, treatment duration, or health condition being studied. During the consent process before enrolling, the research team will explain the specifics about the trial.

Each clinical trial has a specific “protocol” that describes how it will study the intervention, including how participants will be divided into groups, required site visits, and the health outcomes being measured. For instance, participants may be randomly assigned to the investigational intervention, the current standard intervention, or a placebo. We measure safety and effectiveness by comparing data from each group.

There are many different types of trial sites. Trial sites can include hospitals and medical centers, universities, or doctors’ offices. In some studies, there may also be virtual options. Some trials have more than one study location, but each has a full research team.

Not all trials pay participants, but some do compensate for time and travel commitments.

Children are eligible for trials that have been designed specifically for them. For greater protection, regulations and ethical standards for these studies are more rigid. Since children’s bodies are still developing and growing, they can react differently to interventions and it’s important to study and understand the differences. In addition, there are some conditions that only affect children.

Regulatory authorities have strict guidelines that study teams must follow to ensure all patients are treated fairly and safely, and that the trial’s potential benefits outweigh risks. Each study has a “protocol” that includes the necessary protections, and an independent body – who can end the trial at any time – regularly reviews the data.

Yes, participants are volunteers and may leave a clinical trial at any time. Clinical trial medical staff will help a participant leave safely.

Your ”informed consent” is required before being enrolled in a trial. This means you have been provided all relevant information about the study design, how you will participate, your right to leave at any time, study alternatives, and the associated risks and benefits. Informed consent is designed to protect patient safety.

“Standard of care” is the treatment or therapy that is already approved for a specific health condition that is available publicly and that is considered or proven to be the best treatment option. Investigational treatments and therapies in a clinical trial are still being tested to ensure safety and/or effectiveness.

There are two main types of clinical studies:

Interventional studies test new treatments that haven’t been approved yet—like new medicines, diets, or medical devices—to see if they’re safe and work well. People in these studies are usually randomly placed into different groups to compare how each treatment works.

Observational studies look at treatments that are already part of someone’s regular care. Researchers don’t change anything—they just follow participants over time to see how their health changes.

Most of the time, when you hear about clinical trials, they’re usually referring to interventional studies using a new treatment.

In some studies, people are randomly placed into different treatment groups to make sure the results are fair and accurate. Each group might get a different treatment—like the new treatment being tested, the typical treatment, or a placebo (a treatment that looks the same but doesn’t have active ingredients).

To understand how well a new treatment works, researchers need to compare it to people who don’t get the new treatment. This comparison group is called the control group. People in the control group might get a placebo (a treatment that looks real but has no active ingredients), the usual treatment doctors already use, or no treatment at all. This helps researchers see if the new treatment really makes a difference.

Your Primary Contacts while in the study are the Study Team, which usually includes the Study Coordinator/Research Nurse and Principal Investigator.

Study Coordinator or Research Nurse are usually your first point of contact. They can answer questions about:

• Visit schedules
• Procedures
• What to do if you miss a visit

Principal Investigator (PI) is the doctor leading the study. You can reach out to them for:

• Medical concerns
• Side effects
• Medications
• Decisions about continuing in the study