If your liposarcoma treatment isn't working so well, your doctor might suggest you join a clinical trial. It's a way to try a new medicine that isn't available yet to everyone.
Clinical trials are research projects that let doctors make advances in medicine. They're the final step in a years-long process that checks how well new medicines or devices treat conditions and whether they're safe.
The information doctors get from these trials helps them understand how to better diagnose, treat, or prevent diseases like liposarcoma.
Who Can Join?
Every clinical trial has a checklist of requirements for joining a clinical trial. You may hear your doctor call these guidelines "exclusion/inclusion criteria."
The things that you must have to get accepted into a clinical trial are the "inclusion criteria." The ones that prevent you from taking part are "exclusion criteria."
Some of the things that play a role in whether you can join a specific clinical trial are your:
- Stage of disease
- Treatment history
- Other medical conditions
Before you decide to join a clinical trial, you'll need to think about whether you want to take on any risks that may be involved with trying a new drug. You may also need to consider whether you're willing to travel a long way to take part.
Ask yourself these questions to help figure out if you're ready to join:
- What is my goal in taking part in a clinical trial?
- How does my doctor feel about my joining one?
- How do the benefits compare to the risks?
- How much time and money will be involved?
As for safety, the treatments that researchers are studying go through many tests before they make it to a clinical trial. The average time it takes for a new cancer treatment to make it to a clinical trial is 6 years.
All clinical trials are voluntary, and you can decide to leave any time.
How Clinical Trials Work
Typically, clinical trials happen in phases:
Phase I. Researchers try a new drug or test on people for the first time. This phase focuses on safety and side effects. It usually involves a small group -- around 20 to 80 people.
Phase II. More people (100-300) get the treatment, and researchers continue tracking side effects. They also start looking at how well the treatment works.
Phase III. The number of people in the clinical trial expands to 1,000-3,000. Researchers monitor side effects, check how well the drug or device is working, and compare the results to other similar treatments.
Phase IV. At this point in a clinical trial, the FDA approves a treatment for the public while researchers keep tracking its safety and how well it works.
If you're enrolled into a clinical trial phase, you'll have an initial visit, called a baseline visit, where the researchers will perform physical and mental tests to get a good picture of your health. In some phase II or higher clinical trials, you'll be assigned at random to a group:
- Control group. These people receive the current standard treatment.
- Treatment or investigational group. The people in this group get the new treatment.
In some clinical trials, participants don't know which group they're in. This is called a "single-blind" trial.
In other clinical trials, neither the people in the clinical trial nor the researchers running it know who is getting which treatment. This is called a "double-blind" trial. Single- and double-blind trials help prevent bias in both researchers and participants.
You may have heard of clinical trials that assign some participants to use a "placebo" -- something that looks like a medicine but doesn't actually treat any conditions. Researchers hardly ever use placebos in cancer clinical trials. Doctors always let you know if the trial you're in uses placebos.
How to Find a Clinical Trial
First, talk to your doctor about whether any current liposarcoma trials might be right for you. You can also search online for clinicaltrials.gov or the Sarcoma Foundation of America for active clinical trials.
If you find a clinical trial you'd like to join, contact the coordinator in charge, usually called the principal investigator. You'll then go through the screening to see if you meet the requirements to take part. Let your doctor know if you begin the clinical trial process so he or she can help decide if it's safe and also monitor your progress alongside the clinical trial team.
National Cancer Institute: "What are Clinical Trials?" "Randomization and Bias in Cancer Clinical Trials," "Use of Placebos."
National Institute on Aging: "Why Participate in a Clinical Trial? What Else Should I Know?"
National Institutes of Health: "NIH Clinical Research Trials and You."
American Cancer Society: "Making the Decision about Clinical Trials."
Sarcoma Foundation of America: "Sarcoma Clinical Trials."