Your Guide to Understanding Cancer Clinical Trials
Clinical trials play a critical role in developing advanced treatments for cancer. Sylvester Comprehensive Cancer Center offers patients opportunities to participate in cutting-edge research, providing potential early access to promising therapies.
This guide explains the clinical trial process in detail, clarifies common misconceptions, and helps you decide whether a clinical trial might be right for you.
What Are Clinical Trials?
Clinical trials are carefully managed research studies designed to test new cancer treatments, diagnostic methods, or procedures. These trials are crucial for determining if novel therapies are safe and effective, potentially improving upon or replacing current standard treatments.
How do Cancer Clinical Trials Work?
Trials begin with promising ideas tested in labs. If successful, these therapies move into clinical trials involving patient volunteers.
Principal Investigators (PIs), usually experienced cancer doctors or researchers, lead clinical trials. They are responsible for designing the study, ensuring participant safety, and analyzing the results.
Each study has a research team that includes doctors, nurses, clinical trial coordinators, and sometimes social workers or financial navigators.
Types of Clinical Studies
There are two broad categories:
Interventional Trials
- A new drug or drug combination
- A new form of radiation therapy or surgery
- An experimental immunotherapy or targeted therapy
- A different schedule or dose of a standard treatment
Observational Studies
- Collect data on long-term cancer survivors
- Study cancer risk factors or biomarkers
- Monitor quality of life or side effects over time
As the clinical trial moves through a series of steps, called phases, researchers collect information about the proposed treatment's effectiveness and safety.
Clinical Study Steps
- Informed Consent – You’ll be given detailed information about the study and asked to sign a consent form. You can leave the trial at any time.
- Screening – The study team will make sure you qualify. Trials often have strict eligibility criteria based on:
- Cancer type and stage
- Previous treatments
- Age and overall health
- Genetic markers or lab results
- Randomization — In some trials, participants may be randomly assigned to a treatment group (experimental or standard). You’ll know if this applies before enrolling.
- Treatment & Monitoring – You’ll receive the study treatment and be closely monitored for side effects, treatment response, and any health changes.
- Follow-up – Even after the treatment phase ends, you’ll usually have scheduled visits or check-ins for ongoing evaluation.
Clinical trials at Sylvester are governed by strict safety standards and ethical guidelines, and they are overseen by independent Institutional Review Boards (IRBs) to protect patient welfare and rights.
What About Placebos?
Placebos (inactive treatments) are rarely used in cancer treatment trials.
If a placebo is involved, it’s typically added to standard treatment to test whether the new drug adds any benefit. You’ll always be told if there’s a chance of receiving a placebo, and you won’t be left untreated.
Phases of Clinical Trials Explained
Each phase of a clinical trial has a different purpose. The further a new drug or treatment moves through the phases, the closer it gets to earning regulatory approval from the Food and Drug Administration (FDA).
- Phase I
- Sylvester researchers test a drug or treatment in a small group
- Purpose: to study the drug or treatment, learn about its safety, and identify any side effects
- Question to answer: Is it safe?
- Phase II
- Researchers test the new drug or treatment in a larger group
- Purpose: to determine effectiveness and further study safety
- Question to answer: Does it work?
- Phase III
- Researchers test the new drug or treatment in a large group
- Purpose: to confirm effectiveness, monitor side effects, compare with standard or similar treatments, and collect information that will allow safe use of the new drug or treatment
- Question to answer: Is it better?
- Phase IV
- Researchers track the safety of a new drug or treatment in the general population after it wins FDA approval.
- Purpose: to learn more about benefits and optimal use
- Question to answer: What else is there to know about it?
Learn about our Phase 1 clinical trials program.
Who Can Join a Clinical Trial?
Clinical trials develop eligibility criteria for two main reasons. The first is identifying patients with enough in common to determine the effectiveness of a proposed cancer drug or therapy. The second is to protect patients whose participation may endanger their health (e.g., they have another medical condition that could put them at risk).
Some of the standard eligibility criteria consider a patient’s:
- Age
- Current medical condition
- Medical history
- Prior treatments received
- Type and stage of cancer
Contrary to some myths, clinical trials are not only for those who have exhausted standard treatments. Many trials aim to find better first-line treatments, offering promising alternatives to standard care even at early stages.
Another misconception is that participants will not have access to the experimental treatment after a clinical trial ends, even if it is working. However, patients can continue with the treatment after the trial ends.
How to Enroll in a Cancer Clinical Trial
- Talk to Your Doctor. Ask if there are trials available for your type of cancer and situation. Your doctor can help identify options.
- Search for Trials. You can also do your own research and look through our database of ongoing clinical trials. However, you must still discuss your findings with your doctor and get a referral.
- Contact the Study Team. The clinical trial coordinator or navigator can answer questions and explain the requirements.
- Pre-Screening. You may need blood work, scans, or a review of your medical records to determine your eligibility. If you meet the eligibility criteria, we’ll initiate you into the trial and start treatment.
- Informed Consent. You’ll receive detailed written information about the study, including:
- Purpose of the study
- Treatments involved
- Potential risks and benefits
- Your rights (including the right to withdraw at any time)
- Begin the Trial. If enrolled, you’ll follow a treatment and monitoring plan, with regular check-ins and data collection.
Benefits and Risks: What to Know
Potential Benefits
- Access to cutting-edge treatment
- Specialized care team and frequent check-ins
- Helping advance cancer research
Possible Risks
- Side effects (known and unknown)
- Treatment may not work
- Time commitment (more visits, tests, travel)
- You might be placed in a control group that doesn’t receive the new treatment
Questions to Ask Before Joining a Clinical Trial
Here are some questions that can help you make a confident decision:
- What’s the goal of this study?
- What treatment will I receive?
- What are the possible risks and benefits?
- What will my costs be? Will my insurance cover them?
- How often will I need to come in?
- What happens if I leave the study?
- Will I be able to continue the treatment after the study ends?
Bring these questions to your oncologist or the study coordinator—they’ll walk you through everything.
Additional Tips for Participants:
- Bring a family member or friend to discussions about enrollment for support and assistance.
- Prepare a list of questions ahead of time to discuss all concerns.
- Keep track of all trial-related information and documents for your records.
Learn answers to frequently asked questions about clinical trials.
Why Choose Sylvester for a Clinical Trial?
Sylvester is South Florida’s academic-based cancer center. We’re home to more than 3,100 doctors, researchers, and staff members working together to discover, develop, and deliver world-class care for cancer.
Our experts receive international recognition for their advancements in cancer research and care. They work in multidisciplinary, collaborative teams to offer personalized treatment plans tailored to your specific cancer and individual health needs and goals.
We are South Florida’s only:
- National Cancer Institute (NCI)-designated cancer center
- Academic-based comprehensive cancer center
- U.S. News & World Report-recognized high-performing cancer center
- Phase 1 clinical trials program
The NCI designation means we meet rigorous standards for transdisciplinary, state-of-the-art research focused on developing new and better approaches to preventing, diagnosing, and treating cancer. It also further expands our ability to care for patients, including increased access to novel therapies and clinical trials.
To schedule an appointment at Sylvester, call 1-844-324-HOPE (4673) or request an appointment online.