Joining a clinical trial is a deeply personal choice. With so many factors to consider, the decision may feel overwhelming. The information provided here is designed to help you make an informed choice about participating in a clinical trial.
A clinical trial is a scientific study that assesses a drug or therapy in people. Clinical trials may also be called clinical studies or clinical research. Clinical research helps us answer specific questions about the drug being studied, such as whether it is safe and effective.
The path to developing a new medicine is a rigorous journey that may have stops and starts along the way. The process and duration can look different depending on the study, but no matter what, the research team will do what it takes to ensure each medicine is tested thoroughly.
You, or your family member! The participant may also be called the patient, volunteer, or study subject.
Where the trial happens: may be a clinic, hospital, academic institution, doctor's office, or even your home.
The doctor or researcher responsible for conducting the trial. May also be called the study doctor.
The research assistant who supports the Investigator to conduct the clinical trial.
Ethics Review Boards
They protect you by reviewing the study to ensure it is ethical and fair.
They are doctors, hospitals, pharmaceutical companies or other groups that initiate the clinical trial.
Every day, all over the world, countless people are involved in clinical trials, on the quest to find new and improved medicines. These medicines may offer potential treatment options for generations to come. Clinical trials provide valuable information that might help improve medical research and knowledge. But at the core of clinical research are the study participants who make it all possible.
People choose to participate in clinical trials for a variety of reasons. They may want to monitor and better understand their own disease or help advance medical research that may benefit others. Whatever the motivation, choosing to participate in a clinical trial is a personal and individual decision.
Every clinical trial is unique. Anyone interested in participating in a clinical trial should know as much as possible about the study and feel comfortable asking the research team questions about the study, the related procedures, and any expenses.
Before meeting with the research coordinator or study doctor, plan ahead and write down some questions to ask. You may also wish to discuss this decision with your family, friends, or doctor. Feel free to bring a friend or relative with you for support and to hear the responses to your questions.
The following questions might be helpful during such a discussion:
Before joining a clinical trial, participants are given information about the study and have the chance to ask questions. This process is called informed consent. The purpose of the informed consent process is to make sure participants understand important details about the clinical trial so they can make an informed choice about participating. Informed consent begins before a research volunteer agrees to participate in a trial and continues throughout the study.
The informed consent document describes the study details. It includes the study’s purpose, length, procedures, risks and benefits, and other information that all participants should know. After discussing the study details, volunteers will sign the informed consent document. There may be more than one document for a study. The informed consent document is not a contract. Participants may withdraw from a study at any time, even if the study is not over.
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participants.
We follow the strict regulatory and ethical guidelines of the FDA and Ethics Review Boards.
We will inform you of the known risks and the benefits before your trial starts (also known as informed consent).
Ask as many questions as you want. We will always answer.
You can withdraw from a trial at any time and for any reason.
You would contribute to the long history of clinical trial volunteers around the world.
You will make a difference.
Your participation may help develop new treatments that can make lives better.
You join the community.
You can discuss continuing treatment.
The trial might move forward and might not.
The drug can be approved for use.
You can access results of the research.