What you need to know about clinical trials

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 is better than the treatments or procedures we already have. Studies are also conducted to identify who may be at greater risk for a particular condition and how to diagnose or prevent the disease or prevent a disease from coming back.

How do clinical trials work?

After treatments, procedures, or interventions have been tested in labs and on animals, those that show promising results are moved into clinical trials.

There are several phases of clinical trials.

  • Phase 1 studies: Researchers study whether a new treatment is safe.
  • Phase 2 studies: Researchers examine whether a new treatment works for a specific disease and whether the new treatment is better than available treatments. They also continue to look into 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 effect). Side effects continue to be monitored and other information is gathered to 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 a drug has been 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 disease. Scientists study new treatments in relatively small groups and learn 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 help scientists find 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 react differently to treatments and procedures. Scientists can find the best ways to treat your disease in all kinds of people when they have all kinds 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 available treatments. Clinical trials can offer hope and may give you the chance to get a treatment that might work. You may also get a new treatment before it’s available to everyone else, and access 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. The help you receive in a clinical trial is considered investigational, so talk to your healthcare professional before making any decisions about joining a clinical trial. Standard treatments are the best approaches currently available, while clinical trials are looking for even better treatments.

How do I access a clinical trial?

Your healthcare professional may tell you about clinical trials, or you can look for one on their own. To enter a clinical trial, you’ll need to meet certain criteria, such as 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 healthcare professional or someone 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 am currently being treated?

You can participate in a trial in a different location. 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 being conducted. If you need to travel to a different location, you’ll need to consider travel arrangements, job responsibilities, childcare, pet care, and any other responsibilities that will need to be covered while you’re away.

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

There may be different types of costs associated with participation 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 might normally get. 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 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 participate in a clinical trial?

Not necessarily. If there is a standard treatment for your condition, you will follow it if you are given a placebo in the study. It would be unethical for researchers to stop 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 medical treatment, test, or procedure, have some risks. Researchers 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 they can begin testing, so they must strictly follow the IRB-approved research plan. Following the IRB also helps ensure that your research results are as reliable as possible.

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

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

Are clinical trials always a last resort?

Some people assume that you would only participate in clinical research if you have no more treatment options. But that’s not true: For many people, clinical trials offer the hope of getting an even better treatment than what’s currently available.

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

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

This resource was created with the support of Cancer Care.

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