FAQs

Clinical trials are the primary way to understand if an investigational treatment, such as a drug, diet, or medical device (such as a pacemaker) is safe and effective in people.

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. Clinical trials may look for participants who have a specific disease or disorder, but some also look for healthy participants.

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.
• Having the chance to help others by identifying treatment options for those who are affected by a disease or condition.

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. 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.

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.

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.

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.

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.

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.

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

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.

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 safely support removing a patient from a trial when needed.

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.

Interventional studies test new treatments that are not yet approved by regulators, while observational studies evaluate approved treatments by tracking participant health outcomes over time. In interventional studies, participants are often assigned randomly to different groups with different treatments for comparison. In observational studies, participants are not assigned a treatment, it is already part of their healthcare regimen. (Most references to clinical trials on this site refer primarily to interventional studies.)

To ensure quality data and no bias when comparisons need to be made between study groups, each participant is randomly assigned to a group (i.e., experimental intervention, standard intervention, or placebo).

A placebo is an inactive version of an intervention that is not intended to provide any medical benefit. It is designed to look the same as the active intervention, so the participant and study team do not know it is a placebo. The placebo is used by comparison to confirm any effects of the intervention being studied, if not approved intervention is available.

Researchers must compare the effects of a new intervention on participants to those who do not receive the intervention. They are called the “control” or “control group,” and may receive either a placebo, the standard of care, or nothing at all.