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What Is a Clinical Trial?
Clinical trials are created so researchers can test how well new medical approaches, such as treatment, work in people. Participation in clinical trials has led to significant progress in the treatment of various cancers, such as endometrial and ovarian cancer. This progress provides doctors with more options for treating their patients and helps improve the likelihood of better health outcomes.
Phases of clinical trials
As a potential clinical trial participant, it’s helpful to have a basic understanding of what clinical trials are all about. To start with, there are four different phases of clinical trials:
Phase 1:
The new drug or treatment is tested in a small group of people to evaluate its safety, including determining the appropriate dose and identifying any side effects.
Phase 2:
The drug or treatment is further evaluated for its safety and the effect it has on the disease that is being targeted within a larger group of people.
Phase 3:
Researchers evaluate the drug or treatment to confirm its effectiveness within large groups of people, monitor side effects, and compare it to the standard treatment.
Phase 4:
After a drug or treatment has been approved and is available to patients, these trials look at the long-term safety and effectiveness.
Who can participate?
Every clinical trial begins with a protocol. This is a detailed plan that explains how the trial will be carried out. The protocol includes strict rules for who can participate in the trial, known as inclusion and exclusion criteria. It also guides doctors and nurses on what steps to follow at specific times during the trial. Regardless of where the doctors are in the world, they conduct the clinical trial in the same manner. Some criteria may include:
- Age
- Health status
- Medical history
- Current medications
When creating a protocol for a clinical trial, statisticians help figure out how many participants are needed. They ensure that the sample size is large enough to help provide greater confidence in the trial’s findings.
Why should I consider participating?
When considering whether to participate in a gynecologic cancer clinical study, there’s a lot to think about, including deciding whether a specific trial is right for you. Your healthcare professional can help you assess and determine whether a clinical trial is right for you.
The informed consent form is a document that explains what the clinical study will involve. This longer document includes information about the details of the clinical study, the procedures involved, and the possible benefits and risks, etc. It also lets study participants know that they are free to withdraw their consent and drop out of the study at any time. Because this form contains so much information, you might want to spend time reading it again at home before deciding whether the trial is right for you. You should discuss informed consent with your healthcare team.
Common Questions About Clinical Trials
1. Will I get a placebo if I am in a clinical trial for cancer?
Placebos, which are inactive substances like sugar pills that look like real medicine, are usually only used when there is no effective treatment for the type of cancer being studied. Even then, patients should expect to still receive the new drug under evaluation or the standard care that is normally given for their cancer.
2. Are clinical trials only for people who have late-stage cancer, after all other treatment options have been exhausted?
Clinical trials offer the opportunity to receive potential new investigational treatments before they are FDA approved and made available to the public. Some trials are designed for patients who have had multiple relapses after various treatments, while others focus on patients who are newly diagnosed and have never been treated before. Since the availability of trials depends on factors such as location, timing, cancer type, and treatment history, it’s crucial to talk to your doctor about which clinical trials might be suitable for you.
3. Does it cost a lot of money to participate in a clinical trial?
Many clinical trial costs are covered by the sponsor of the study and a patient’s insurance plan, if one is available. Sometimes, there are out-of-pocket costs. Before you join a study, ask the trial coordinator which costs are covered and which are not.
4. Will I be stuck in the trial if I agree to participate and then change my mind?
As a participant in a clinical trial, you have the right to leave the trial at any time and for any reason.
5. How do I find out about clinical trials that might be right for me?
Clinical trials are offered throughout the United States and other countries around the world. If you have interest in participating in a clinical trial, talk with your doctor who may be able to help you find options that could be right for you based on your location, cancer type, and treatment history.
6. Will I have to switch doctors if I participate in a clinical trial?
If your doctor is not personally conducting a clinical trial that you want to participate in, you may still continue to see them throughout the trial, as it is important to continue receiving your standard care and to make sure that any new medications do not conflict with your regular treatment plan. You should talk with the trial doctor to be sure they are in contact with your primary doctor regarding your participation in the clinical trial.
7. Can I participate in a clinical trial if I don’t live near a major hospital?
Clinical trials are offered in various medical settings, including community hospitals and clinics, not just at major medical centers.
8. What protections are in place for clinical trial participants today?
Today, clinical trials are conducted under strict guidelines to protect participants. These guidelines include oversight by independent review boards (IRBs), which ensure the trial is ethical and the rights and safety of participants are prioritized. If you’re considering joining a trial, seek out resources that explain the process clearly, connect with organizations dedicated to supporting patients in clinical research, and talk with your healthcare provider.
9. What do clinical trials measure to find out whether a treatment is safe and effective?
Clinical trial investigators often use two main ways (also known as endpoints) to see how well a treatment is working for cancer:
- Overall survival (OS): This looks at how long people live, on average, after they start treatment. It is one of the most important ways to measure how well a treatment works in cancer studies. Overall survival is considered a high standard in cancer clinical trials.
- Progression-free survival (PFS): This looks at how long people live without their cancer growing, spreading, or getting worse after treatment starts.
Clinical trials that show a benefit in overall survival and progression-free survival demonstrate that a cancer treatment is effective. It’s also important to understand how safety was measured in the clinical trial, since tracking side effects and long-term risks helps researchers determine whether a treatment’s potential benefits outweigh its harms.
10. What does statistically significant mean in real life?
Statistically significant means that the results are unlikely to have happened by chance. It tells researchers that a treatment probably had a real effect, but it does not necessarily mean the benefit was large, guaranteed, or right for every person. When you hear the term statistical significance, it’s important to ask how big the benefit was, what side effects occurred, and whether the results apply to you.
11. What does safety profile mean?
The safety profile of a treatment describes what’s known about side effects, including how common they are and how serious they can be. Safety profiles are continually assessed over time as more people receive a particular treatment.
12. What does it mean if my tumor is being used for biomarker testing?
In a clinical trial, biomarker testing means a sample of your tumor is analyzed to look for specific features, such as genes or proteins, that may help researchers understand how a treatment works and who may benefit from it. These biomarkers can be used to decide whether you are eligible for a trial, to help match you to a treatment being studied, or to better understand why some people respond to a treatment and others do not. Biomarker testing in trials also helps improve future treatments, even if it does not change your own care. Learn more about common biomarkers in endometrial cancer and ovarian cancer.
Finding a Clinical Trial
For more information about clinical studies in ovarian, endometrial, or other gynecologic cancers, talk with your healthcare professional. You may also click below to visit the searchable Clinicaltrials.gov website. Additionally, our advocacy organization page may feature groups that can provide information on clinical studies.
Learn Common Gynecologic Terms
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