Let’s talk
Start with a question.
Tell us what you’re looking for. We’ll ask a few questions and explain which studies may be worth exploring. You don’t need to decide on that first call.
Asking about a study doesn’t sign you up for it.
For patients and families
Curious about a clinical trial?
You don’t need to know all the medical terms. Let’s walk through what joining a study could be like, one step at a time.
A little information. Room for questions. No pressure to decide today.
First, what is a clinical trial?
It’s a research study with volunteers. It helps us learn how a treatment affects people, including its benefits and risks. Taking part may or may not help your own health.
Your experience, step by step
Here’s what it could look like.
Every study is different. This is a starting point, and you can take your time.
Your decision
Your questions come first.
We’ll explain the visits, possible risks and benefits, and your other options. Read the consent information and take time to decide. If you choose to join, consent comes before any study-specific tests.
A good question to ask: “How would this fit into my everyday life?”
Your first visit
Does this study fit you?
A screening visit may include health questions, an exam, or tests. The research doctor checks whether you meet the study’s requirements. Being screened doesn’t guarantee you can join.
Each study has different requirements. Not qualifying is not your fault.
Study visits
Know the plan. Stay in touch.
If you join, we’ll explain your visits and what to do between them. You may need to take study medicine, answer questions, or keep a health diary, depending on the study.
Tell us about health changes or trouble making a visit. We’ll talk it through.
What’s next
Know what comes next.
Your team explains any final visits and follow-up. Ask about your regular care, whether study treatment continues, and how to hear about the results. Continued access to study treatment isn’t guaranteed.
What researchers learn can help guide future studies, even when a treatment doesn’t work.
Step 1 of 5
You can change your mind.
Joining is voluntary. You can leave a study at any time without losing your regular medical care. Let the team know so you can discuss how to stop safely and any follow-up you may need.
Real questions. Clear answers.
You might be wondering…
These are good things to ask. If you’re thinking it, bring it up.
Will the treatment help me?
It might, but there’s no guarantee. The treatment may not work, and side effects can be mild or serious. Ask the team what is known, what is still uncertain, and how the study compares with your other options.
Will everyone get the same treatment?
Not always. Some studies assign treatment groups by chance, like drawing names. A group may receive a usual treatment or a placebo, which has no active study medicine. You may not know your assigned group during the study. The team will explain whether this applies before you decide.
What about costs, payment, or travel?
These depend on the study. Ask which costs are covered, whether there is payment or reimbursement, and whether travel support is available. It’s okay to ask for the details before deciding.
Can I keep seeing my regular doctor?
A study doesn’t replace your regular healthcare. Talk with your doctor and the research team about how your care would work together, including any study rules about medicines or treatments.
Who looks out for me?
The research team follows your health during the study. An independent review board also reviews the study and consent information to help protect participants. These safeguards don’t remove every risk. Ask who to contact if something changes or you have a concern.
A little more, if you’re curiousHow do studies lead to new medicines?Explore the bigger picture, from the first idea to life after approval.
Medicines take time to develop, often years. Volunteers help researchers learn what works, what doesn’t, and what risks to watch for. Joining one study doesn’t mean going through every phase.
It starts with an idea.
Researchers look for new ways to treat a condition. Laboratory and animal studies help them decide which possible medicines are ready to be studied in people. Many ideas don’t make it that far.
Volunteers help answer the questions.
Before a new drug trial starts, its plan and safety information go through required reviews. Studies then ask different questions, in stages called phases.
- Phase I
- What dose and side effects should we understand first?
- Phase II
- Does it seem to help people with this condition?
- Phase III
- What do larger studies tell us about benefits and risks?
The evidence gets a close look.
If the developer asks for approval, the FDA reviews the results, how the medicine is made, and its proposed labeling. Approval isn’t automatic.
The learning continues.
After approval, safety monitoring and further research, including Phase IV studies, help us learn more as a medicine is used by more people.
Start wherever you are
Still have questions? That’s okay.
Talk with our team in English or Spanish, in Miami Lakes or Puerto Rico. You don’t have to be ready to join to reach out.
Sources and further reading
This is a general guide. Your study team and consent information explain the details for a particular study. These FDA and NIH resources are in English.