Moores Cancer Center boasts one third of the approximate 60 active immunotherapy focused clinical trials. Options are being investigated including chimeric antigen receptor (CAR) T-cell therapy, which uses patient immune response to eliminate abnormal cells through genetic modification; combination therapy for advanced cancers, which has shown a mix of checkpoint inhibitors and chemotherapy to be effective against typically resistant metastatic cancer in study models; and how modulating tumor microenvironments can achieve improved efficacy of checkpoint inhibitors.
What are Clinical Trials?
- Research studies that involve people
- Designed to answer specific questions about new and existing treatments
- Aim to improve treatments and the quality of life for people with disease
What are Clinical Trial Phases?
Phase 1
| Phase 2
| Phase 3
|
Is the treatment
safe?
| Does it work?
| Does it work better?
|
First study in humans
| Look for effect on specific type/s of cance
| Compare new treatment (or new use of a treatment)
|
Find best dose,delivery method, schedule, monitor for side effects
and determine safety
| Continue monitoring for side effects and safety
| Determine risk vs. benefit
|
Number of people:
20-100
| Number of people:
100-500
| Number of people: 1,000-5K+
|
Pros and Cons of Clinical Trials
Potential Advantages | Potential Disadvantages |
| Access to best possible care | Unknown side effects or risks |
| Receiving new drugs before they're widely available | Unknown benefits-drugs may not work as intended |
| Close monitoring by medical team | Not all patients may benefit |
| Chance to play active role in healthcare and research | Frequent tests and clinic visits |
| Help future generations | Possible need to travel to trial sites |
Questions to Ask Before Volunteering
Why is this trial being done? Why is it believed that the treatment being studied may be better than the standard treatment? What are my other options (standard treatments, other trials)? How did patients do in any previous studies of this treatment? How will the doctor know if treatment is working? How long will the trial last?Can I continue to receive this treatment after the trial ends? What kinds of procedures or tests are involved? What impact with the trial have on my daily life? Will I have to travel for treatment? Will I be compensated? How often will I need to travel to receive treatment? Will I be hospitalized as part of the trial? What costs (if any) will be my responsibility to pay?
Getting into a Clinical Trial Isn’t Always a Given
Trials are designed to ask specific questions, and must adhere strictly to entry criteria to ensure data is accurate and meaningful.
Common criteria include:
• cancer type or stage
• treatment history
• genetic factors
• age
• medical history
• current health status
Clinical Trials: Myth versus Fact
MYTH | FACT
|
| I might only get placebo (“sugar pill”) instead of treatment. | Placebos are rarely used and never given in the absence of some form of treatment. |
| Trials are only for people who have run out of treatment options (a “last resort”). | Clinical trials are designed for people with cancer of all types and stages. |
| My health insurance doesn’t cover the cost of care in a clinical trial. | Doctor visits, hospital stays, and certain testing procedures may be covered by insurance. Research costs are typically covered by the trial sponsor. |
| Signing a consent form “locks” me into staying in a trial. | You are free to change your mind for any reason about participating in a trial anytime before or during a trial. |
| I will be made to feel like a “guinea pig” experiment. | The overwhelming majority of trial participants say they were treated with dignity and respect, and report having had a positive experience in a trial. |
| Clinical trials aren’t safe. | Safeguards including an Institutional Review Board, Data and Safety Monitoring Board, and an ongoing informed consent process ensure patients’ rights and safety are protected. |
A Word About Informed Consent
Informed consent = having all the facts before and during a trial
Study purpose
Length of time of the study
Predictable risks
Possible benefits
Expectations
Patient's rights
Patient health monitoring
Safeguards in place
How to withdraw from study
Be bold in asking for details. It’s YOUR treatment plan.
Patient Resource, "Understanding Clinical Trials: A Guide for Patients and Their Families"