Before a new medical intervention can be approved for use, it must be shown to be safe and effective. Clinical trials are a critical part of this process.

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 experimental intervention, the current standard intervention or a placebo. The comparison of data from each group is how safety and effectiveness are measured.

Volunteers who match study requirements, such as gender, age, condition, or treatment history, can join a clinical trial. A member of the research team will screen all volunteers to confirm they meet the requirements of the trial.

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 withdraw at any time, study alternatives, your personal data protection and the associated risks and benefits. Informed consent is designed to protect patient safety and privacy.

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.

Trial sites include hospitals and medical centers, universities and doctors’ offices. Some trials have more than one study location, but each has a full research team.

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, they can react differently to interventions and it is important to study and understand the differences. In addition, there are many conditions that only affect children. They will need to have a parent or legal guardian who signs the consent forms and oversees whether a child should continue to participate in the study.

For the best possible clinical trial results, participants should attend each scheduled trial visit. If you have a conflict, please contact your research team in advance to adjust your schedule.

Participants are always welcome to visit their usual healthcare providers during a trial. Sometimes, it is important for healthcare providers to collaborate with the research team to ensure success.

There may be some potential and real risks in participation. The experimental intervention might be less effective than current, standard interventions if available for the indication being studied. You could experience side effects. However, precautions are built into the study design to help ensure the safety of participants as much as possible. Many clinical trials have a Data Safety Monitoring Board (DSMB), a group of experts that is separate from the company and researchers running the trial who regularly reviews trial data. The DSMB has the ability to end the trial if the intervention being studied is found to be unsafe or far less effective than the standard of care or placebo. You may always withdraw from the trial at any time if desired.

Not all trials pay participants, but some do receive modest compensation for reimbursement for travel, and study-related time and commitment. The amount varies. The research team will provide you these details if they apply.

Due to the many differences in insurance plans across the country, coverage in clinical trials can vary. You will learn more about your options during pre-screening.

As with all medical records, participant privacy and confidentiality in trials are protected by law. Once consent is signed, you will be given a trial code. Your trial records will not include your name or personal identity but will identify you with a trial code. This code can only be tracked back to you via a code key which is held by the responsible physician. Your name or personal identity will never be disclosed.

Yes, participants are volunteers and may withdraw from a clinical trial at any time.

Regulatory agencies have strict guidelines that research teams must follow to ensure all patients are treated fairly and safely, and that the trial's potential benefits outweigh risks. Each trial has a "protocol" that includes necessary protections, and an Institutional Review Board/Ethics Committee (IRB/EC) that reviews the data and can end the trial at any time.