Clinical Trial Basics
Interventions can include drugs, vaccines, medical devices, medical procedures and behavioral interventions.
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.
No, you are welcome to inquire about participating in any ongoing study directly.
If you don’t qualify due to not meeting the trial criteria, you should check with your healthcare provider to seek other options.
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.
If you are living with a medical condition, joining a clinical trial may give you access to a new potential treatment before it is publicly available. Just as importantly, it can help researchers understand how this potential treatment affects the body and increase their knowledge about the disease and how to treat it. Participation can also play a vital role in helping others who have a similar condition, both now and in the future. Healthy volunteers in trials contribute to this medical progress as well by helping understand the effect of the potential treatment and any safety concerns.
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.