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What to Expect During a Clinical Trial

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Learning about the clinical trial process can help you make an informed decision about joining.

Most clinical trials follow similar steps before, during, and after you sign up.  

If you are thinking about joining a trial, talk with your doctor about ones they recommend. You can also find a trial and reach out to the study team on your own. Review our Steps to Find a Clinical Trial and Facts about Clinical Trials pages for more information. 

Before you are enrolled

Pre-screening

The first step to joining a clinical trial is a pre-screening meeting. All studies have specific requirements that outline who can take part. For example, you may need to be within a certain age range or have a certain type of cancer to proceed.

At the pre-screening stage, a study team member such as a research nurse or study coordinator will tell you more about the trial and ask questions to see if you might be able to join. They may go over:

  • the goals of the trial
  • the drug being tested, how it works, and what is known about its side effects
  • the number of visits required
  • types of support the trial provides
  • insurance coverage and alternatives

Be sure to ask questions along the way. Participating in a trial is safe, and each one follows ethical rules and regulations to make sure of this. Your privacy is also protected, and you can leave at any time.

Informed consent

If you are found eligible to take part during the pre-screening, you will be asked to go through the informed consent process and sign a consent form. During this process, the study team will explain the trial in-depth, as outlined in the trial protocol. At this stage, you decide if you want to participate.

What is a clinical trial protocol?

The trial protocol is a detailed plan that a clinical trial follows. It describes the goal, who is eligible to take part, participant protections, details about any testing, procedures, and treatments, the length of the trial, and what information will be collected.

For children, the process is a little different. Clinical trials already have a lot of safety guardrails. But extra protections are often added when children are involved, including during the consent process. Children under 18 cannot give informed consent. If you are a parent, you would need to give permission for your child to participate in a trial, and your child would have to go through the assent process to agree to take part.  

Screening

Around the time you sign the informed consent form, the study team will review your medical history and conduct any necessary tests to make sure you meet all the requirements. You may not be able to take part in the trial based on insights from your medical history or test results. This is called the screening stage, which is more thorough than pre-screening.  

Taking part in a trial

Your participation begins after screening and informed consent. The study team will provide detailed instructions on visits and procedures. Your health and safety are regularly monitored.

Where a trial is located, what procedures (if any) are involved, how many visits are needed, and other details differ between trials. So, your time commitment will vary depending on how the trial is designed.

The type of support you get will also vary. Support may include:

  • communication with your current health care team
  • specific guidance and information related to managing symptoms and ongoing care
  • reimbursement for your time
  • travel, transportation, and lodging cost coverage, or even
  • notes for your employer or school stating that you may miss days due to appointments

Not all trials cover expenses. The study team will go over these details at pre-screening, during the informed consent process, and before you begin any trial procedures. Learn more about paying for clinical trials and federal support.

When your time in a trial ends

Your participation can end in a few ways:

  • The trial has ended, been completed, or discontinued.
  • You have gone through all visits and procedures.
  • You decide to leave.
  • The study team decides it is in your best interest to leave.

Here’s what you can do after your participation ends:

  • Request access to the results of your trial, if they are available.
  • Work with your study team or regular care team to discuss the best next steps for your care.
  • You may have the option to continue treatment outside of the trial.
  • The study team may follow up with you in the future to see how you are doing after the trial.
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