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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 preventative measure is safe and effective, or if it is better than the treatments or procedures we already have available. Studies are also conducted to identify who may be at greater risk of having a specific condition or how to diagnose or prevent a disease or prevent its recurrence.

How do clinical trials work?

After treatments, procedures, or interventions have been tested in laboratories and on animals, those that show promise move on to clinical trials.

Clinical trials have several stages.

• Phase 1 studies: Researchers study whether a new treatment is safe.
• Phase 2 studies: Researchers test whether a new treatment works for a specific disease and whether that treatment is better than others already available. They are still evaluating its safety and side effects.
• Phase 3 studies: Researchers confirm the treatment’s effectiveness and compare it to an existing treatment (if any) or a placebo (a substance with no physical effects). Side effects continue to be monitored and other information is gathered that will allow the drug or treatment to be used safely in a larger group of people.
• Phase 4 studies: Researchers continue to monitor safety and optimal use after FDA (Food and pharmaceutical administration) approves the drug.

A patient typically only participates in one phase.

Clinical trials test new things in people, which can put them at risk of experiencing side effects.

Why are clinical trials important?

Clinical trials are important for discovering new and safe ways to fight or prevent disease. Scientists study new treatments in relatively small groups and gain insights into likely effects on other patients now and in the future.

Why would it be convenient to participate in a clinical trial?

When you participate in clinical trials, you help scientists discover new ways to treat your disease.

Clinical trials work best when people of different ages, races, ethnicities and genders participate. Diversity in clinical trials is essential because people with different characteristics may experience disease differently and also react differently to procedural treatments. Scientists can discover the best ways to treat disease in all kinds of people when they have all kinds of people in their studies.

Participation in clinical trials is beneficial to other people, but it can also benefit you directly. There may not be an approved treatment available, or you may have tried all available treatments. Clinical trials could offer hope and give you the chance to receive a treatment that may work. You may also get a new treatment before it’s available to everyone else, and have access to health care providers (HCPs) and other resources you didn’t have before you entered the clinical trial.

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

Clinical trials are different from standard medical care which has already been studied. Treatment you receive in a clinical trial is considered investigational, so discuss it with your healthcare professional before making any decisions about participating in a clinical trial. Standard treatments are the best methods currently available, while clinical trials try to find better methods.

How do I participate in a clinical trial?

Your healthcare professional may tell you about clinical trials, or you may look for one by yourself. To participate in a clinical trial, you must meet certain criteria, such as your age, your specific diagnosis, your genetic profile or your reaction to other treatments.

Someone involved in the study can explain the process, help you determine if you meet the requirements, explain the risks, and answer your questions. Your healthcare professional or someone you seek for a second opinion will be able to help you decide whether you should participate in clinical research.

Can I participate in a clinical trial in a different location than where I currently go for treatment?

You can join a trial elsewhere. In some cases, this may even be your only option if you are not receiving treatment at a large hospital where many clinical trials are taking place. If you have to travel to another location, you’ll need to consider the travel arrangements you need to make, your job responsibilities, the care of your children and pets, and any other responsibilities you need to take care of while you’re gone.

How much does it cost to participate in a clinical trial?

There might be different types of costs related to participation in a clinical study.

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

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

Some clinical trials include payment for participants.

Do I have to stop all other medical treatments if I participate in a clinical trial?

Not necessarily. If there is a standard treatment for your condition, you can continue to receive it if you were given a placebo in the study. It would be unethical for researchers to stop a treatment if one exists, so you will always receive the standard level of care during a clinical trial, even if you receive a placebo.

Are clinical trials safe?

Clinical trials, like any other treatment, test, or procedure, have risks. Investigators are responsible for informing participants of any potential risks. Additionally, to protect study participants from unnecessary risk, researchers must obtain approval from an independent institutional review board (IRB) before testing can begin, and must then strictly follow the IRB-approved research plan. Oversight by the IRB is also helpful in ensuring that research results have the highest level of confidence.

How is my privacy protected if I participate in a clinical trial?

Your information and personal data are confidential. Strict rules govern how health information is stored and shared, and there are other protections for people participating in the studies.

Are clinical trials a last resort?

Some people assume that you only participate in clinical trials if there are no other treatment options. But that’s not true: For many people, clinical trials offer the hope of receiving even better treatment than is currently available.

Once I start participating in a clinical trial, do I have to participate until the end?

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