What You Need to Know About Clinical Trials

What are clinical trials?

Clinical trials are studies of new treatments, procedures or behavioral interventions in people. The goal is to find out if a new treatment or prevention is safe and effective, or if it’s better than treatments or procedures we already have. Studies are also conducted to identify who might be most at risk for a particular condition and how to diagnose or prevent disease, or keep a disease from coming back.

How do clinical trials work?

After treatments, procedures or interventions have been tested in the lab and on animals, those that show promise are moved into clinical trials.

There are several phases of clinical trials.

• Phase 1 trials: Researchers study whether a new treatment is safe.
• Phase 2 trials: Researchers look at whether a new treatment works for a specific disease and if the new treatment is better than available treatments. They also continue to look at safety and side effects.
• Phase 3 trials: Researchers confirm the effectiveness of the treatment and compare it with an existing treatment (if one exists) or a placebo (a substance with no physical effect). Side effects continue to be monitored and other information is collected to allow the drug or treatment to be used safely in a larger group of people.
• Phase 4 trials: Researchers continue to track safety and optimal use after a drug is approved by the FDA.

A patient typically only participates in one phase.

Clinical trials involve testing new things on people, which can put them at risk for side effects.

Why are clinical trials important?

Clinical trials are key to finding new and safe ways to fight and/or prevent diseases. Scientists study new treatments on relatively small groups and learn about the likely effect on other current and future patients.

Why would you want to enroll in a clinical trial?

When you participate in clinical research, you’re helping scientists find new ways to treat your disease.

Clinical trials work best when people of different ages, races, ethnicities and sexes are in them. Diversity in clinical trials is essential because people with different characteristics may experience the disease differently and react to treatments and procedures differently. Scientists can find the best ways to treat your disease in all types of people when they have all types of people in their studies.

Participating in clinical trials helps other people, but it can also help you directly. There may be no approved treatment available for you or you may have tried all of the available treatments. Clinical trials may offer hope and can give you a chance to get a treatment that could work. You also might get a new treatment before it’s available to everyone else and access to healthcare providers (HCPs) and other resources you didn’t have before signing up for the clinical trial.

What’s the difference between standard care and care in a clinical trial?

Clinical trials are different from standard medical care that has already been studied. The care you get in a clinical trial is considered experimental, so talk to your HCP before making any decisions about joining one. Standard treatments are the best approaches that are currently available, while clinical trials are looking for even better ones.

How do I get into a clinical trial?

Your HCP may tell you about clinical trials or you can search for one on your own. To get into a clinical trial, you will have to meet certain criteria, such as your age, specific diagnosis, genetic profile or response to other treatments.

Someone involved in the study can explain the process, help you figure out if you’re eligible, explain the risks and answer your questions. Your HCP or one that you see for a second opinion can help you decide whether to participate in clinical research.

Can I participate in a clinical trial in a different location than where I’m currently being treated?

You can participate in a trial in a different location. In some cases, that might even be your only option if you don’t get care at a large hospital where many clinical trials are done. If you have to travel to a different location, you’ll need to consider travel arrangements, work responsibilities, child care and pet care, and any other responsibilities that will need to be covered while you’re away.

What does it cost to participate in a clinical trial?

There can be different kinds of costs associated with participating in clinical research.

First, you may need routine care, such as doctor visits or hospital stays. Your standard health insurance rules will apply to those costs. For example, your health insurance should pay for care you could normally get. But if you don’t have coverage outside of your health plan’s HCP network, they may not pay for care if you travel to a different medical center to participate in research.

There will also be research costs, such as the drug that’s being studied. Those costs are typically paid for by the study. Sometimes the study will also pay for all or part of your non-research costs.

Some clinical trials include payments to participants.

Will I have to stop all other medical treatments if I’m in a clinical trial?

Not necessarily. If there is a standard treatment for your condition, you’ll stay on it if you’re given a placebo in the study. It would be unethical for researchers to withhold treatment if one exists, so you’ll always get the standard level of care during a clinical trial, even if you receive a placebo.

Are clinical trials safe?

Clinical trials, like any other medical treatments, tests or procedures, do have some risks. Researchers are responsible for telling participants about any potential risks. In addition, to protect study participants from unnecessary risks, researchers must get approval from an independent institutional review board (IRB) before they can begin testing, and then must strictly follow the research plan approved by the IRB. Following the IRB also helps make sure that the results of the research are as reliable as possible.

How is my privacy protected if I join a clinical trial?

Your personal information and data are confidential. Strict rules govern the way healthcare information is stored and shared, and other protections apply to study participants.

Are clinical trials always a last resort?

Some people assume you’d only participate in clinical research if you have no treatment options left. But that’s not true — for many people, clinical trials offer hope of getting an even better treatment than what’s currently available.

Once I start a clinical trial, do I have to stay in it?

No. Participation in clinical trials is voluntary. You can leave a study at any time for any reason.