What are Clinical Trials?
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General Information
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Clinical Trials Office
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HCI-Clinicaltrials@hci.utah.edu
Looking for a research study?
Research studies explore the different factors that affect health and lead to disease.
Clinical trials test the safety and effectiveness of new cancer drugs and treatments. They help us find better ways to prevent, diagnose, and treat cancer. Nearly all current cancer treatments started in a clinical trial.
At any given time, Huntsman Cancer Institute has more than 300 cancer clinical trials open to patients. Taking part in clinical trials is voluntary. Our goal is to find new cancer treatments and improve the quality of life for people with cancer.
Researchers design cancer clinical trials to find new ways to do many things:
- Find and diagnose cancer
- Treat cancer
- Prevent cancer
- Manage cancer symptoms
- Manage side effects caused by cancer treatments
The U.S. Food and Drug Administration (FDA) must approve new treatments before they can be widely used. Clinical trials are part of the approval process for new drugs and treatments. Learn more about from the National Cancer Institute.
How to Find a Clinical Trial
Clinical Trials Search for Patients
Looking for a cancer clinical trial? You can search for a clinical trial by disease, drug, or doctor. You can also look for a clinical trial in a specific phase.
Clinical Trials Search for Providers
Benefits & Risks
Clinical trials are experiments, so they may have benefits and risks. Researchers hope to discover benefits for treating cancer or managing symptoms. The risks depend on the treatment being studied and the health of the people who participate.
Benefits
Patients in clinical trials may receive treatments not yet available to everyone. However, there is no guarantee that clinical trial treatments will help. Taking part in finding new and better cancer treatments can be personally satisfying, as you would be helping others.
Risks
Clinical trial treatments may cause side effects and other health risks. The risks depend on the type of treatment and your health. You always make the final decision about taking part in a clinical trial. You will not start treatment until you fully understand all of the potential benefits and risks. You have the right to stop participating in a clinical trial at any time and for any reason.
Phases of Clinical Trials
Clinical trials start with early discovery and ongoing research. After approval by the FDA, the research goes through the following phases.
Phase 1
- Determine safety and best dosage levels
- 12-24 participants
Phase 2
- Determine how the new treatment affects the body and certain cancers
- Record and analyze data
- Under 100 participants
Phase 3
- Compare results between new and standard treatment
- Hundreds of participants
Phase 4
- Approve and market treatment
- Determine drug safety over time
- Thousands of participants
How to Participate
Patient participants are essential to clinical trials. Ask your doctor if a clinical trial is right for you. Each clinical trial accepts patients with a specific type and stage of cancer. In general, you must meet these conditions:
- Doctors have diagnosed and checked the stage of your cancer.
- A doctor has reviewed your general health, and your health meets study requirements.
- We have answered all your questions about the clinical trial.
- You understand the possible benefits and risks of participating in a clinical trial.
- You have signed and submitted your informed consent form.
Before you decide to take part in a clinical trial, doctors and research teams will tell you all of the known benefits and risks. The research team closely watches the health and safety of every patient who participates.
Informed Consent Form
An informed consent form tells you the purpose, steps, and the benefits and risks of taking part in the clinical trial. These are included to inform you of the details of the clinical trial so you can decide if it is right for you.
Frequently Asked Questions
Why are clinical trials important?
Clinical trials test the effectiveness of new drugs or drug combinations. They provide important insight that cannot be found in a lab setting, helping researchers determine effective cancer treatments.
Are clinical trials safe?
Clinical trials do have risks, like other medical tests, treatments, or procedures. The risks are higher in Phase 1 or Phase 2 clinical trials where fewer participants are involved. Clinical research is overseen by the FDA to ensure trials are designed, conducted, analyzed, and reported according to federal law and good clinical practice regulations.
Clinical trials at Huntsman Cancer Institute are run through a series of committees to determine safety, usefulness, and need prior to opening to patients.
How do I know if a clinical trial is right for me?
The clinical research team will discuss the potential benefits and risks of the clinical trial with you. You will then determine if the possible benefits outweigh the risks. You may want to take part in a clinical trial to help find treatments that could help future patients.
Will my doctor find clinical trials that I may qualify for?
Your doctors may recommend clinical trials to you, depending on the treatment you have previously received and your type of cancer. You can also look for clinical trials you might want to take part in by reviewing the clinical trials available at Huntsman Cancer Institute.
What kind of drugs are available through clinical trials?
A variety of treatments are used in clinical trials. Some are designed to help your immune system. Others target specific genetic changes that cause cancer. The type of treatments or therapies you get will depend on your cancer type and any treatments you have received. You may receive new therapy alone or combined with treatments like chemotherapy or hormone therapy. Other clinical trials may use surgery or radiation to see if they are more effective and/or have fewer side effects.
Your doctors and clinical research team will let you know about the possible benefits of each treatment and any known risks before you begin.
Are clinical trials only for people that have no other treatment options?
Clinical trials are for anyone who meets the trial鈥檚 eligibility criteria, regardless of treatment options. You and your care team can talk about whether you would need to adjust your current treatment plan to consider a clinical trial.
Is there a cost to take part in a clinical trial?
When you take part in a clinical trial, much of the care is the same as if you were receiving a standard treatment. You will continue to see a doctor, have regular lab tests, and get imaging scans as needed. Health insurance often covers these costs, along with any approved treatments that you receive while taking part in the trial.
The clinical trial may require extra tests and procedures to ensure your safety and to gather important information. These research costs are usually not covered by insurance. However, they may be paid for by the study sponsor.
Your doctor or clinical research team will discuss any additional costs with you and answer your questions before you begin treatment. You can also speak with Huntsman Cancer Institute鈥檚 financial advocates about insurance or billing concerns.
How long are clinical trials?
It depends on the phase of the study. You may get a specific number of treatments, or you may stay on the new therapy as long as it is working.
You should always tell your health care team if you have any side effects from the clinical trial. They can treat your symptoms and make sure if is safe for you to continue.
Which providers are involved in my care during the trial?
All clinical trials have a research study team with physicians, advanced practice clinicians, nurses, clinical coordinators, etc. The research study team is available to help answer questions, treat side effects, and assist you.
Can I leave a clinical trial?
Taking part in a clinical trial is always your choice. You can tell your doctor if you want to stop at any time and for any reason.
Clinical Trials Video Series
