What to expect during a clinical trial

The first steps for any clinical trial are to determine that you are eligible, provide your informed consent to participate, and formally enroll in the study. What happens next can vary depending on the specific clinical trial that you join, but the sections below cover some common steps in the process to  help you understand what to expect.

Where do clinical trials happen and for how long?

Clinical trials can take place in many different settings,  including hospitals, clinics, and universities. Though you may find some local clinical trials, others may require you to travel to appointments over the course of days, weeks, months, or even years. In some instances, a clinical trial could require you to stay for an extended period of time at a hospital or another medical facility.

It’s important to know that if you want to leave the study at any point, you have the right to do so and can speak with staff about how to safely stop participating.

The specific steps involved in a clinical trial will depend on the type of trial that you participate in. One of the most common types of clinical trials involves testing new treatments. For these trials, you can generally expect:

• Check-ins: You will probably have a quick physical exam where someone from the trial team checks your vital signs (temperature, blood pressure, etc).
• Treatment: You will receive or take part in the treatment that is being studied. What this looks like depends on exactly what kind of treatment is being tested (i.e., device, medication, therapy, digital tool, supplement, etc.).
• Assessments: You will discuss your symptoms and how you’ve been feeling since your last visit. You may also answer questions from the trial team and review treatment logs. Depending on the type of treatment being studied, you may be asked to provide a blood or urine sample or get imaging done.
• Medical history review: The trial team will ask if there have been any changes in your health or if you have started taking any new medications every time you meet.

Remember, if you decide to participate in a clinical trial, you have the right to say no. This means that you can decline to answer questions, refuse tests or procedures, or leave the trial entirely. 

The members of a clinical trial team are specially trained to monitor your symptoms and ensure your safety during the study. Below is some information about the key roles of clinical trial team members.

• Principal investigator (PI): This is the head researcher who manages the study. The PI makes sure the trial is conducted according to the approved plan and keeps participants safe. You may meet with the PI during your first visit (also called a baseline visit) or for other key check-ins.
• Study coordinator: This will likely be your main point of contact. They handle visit scheduling, appointment reminders, and respond to questions about the study schedule.
• Study clinicians/therapists: These are the nurses, doctors, therapists, or other trained professionals who give you the treatment, monitor how you feel, and do tests (like taking blood samples or doing physical exams) to monitor your health.

Communication is key when you participate in a clinical trial, and you are encouraged to ask questions and voice your concerns. Every clinical trial must follow strict legal and ethical rules to protect the safety and rights of the people who participate.

• Reporting side effects: The clinical trial team will tell you when and how to let them know if you experience any side effects or unusual changes. You should report these right away. If people are experiencing serious side effects or reactions, a trial will be stopped.
• Mental health crises: The clinical trial team needs to have a clear emergency plan. During the informed consent stage (before the trial begins), find out who to contact and what actions they will take to keep you safe if you have a crisis during the study. If you need immediate help, you can always call or text 988.
• Talking to your usual providers: Keep visiting your usual care providers to get your regular healthcare during the study. Talk to your usual providers about joining the trial so they know how it can affect your regular treatment and can work with the study team.