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What Is a Clinical Study?
Clinical studies are created so researchers can test how well new medical approaches, such as treatment, work in people. Participation in clinical studies 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 studies
As a potential clinical study participant, it’s helpful to have a basic understanding of what clinical studies are all about. To start with, there are four different phases of clinical studies:
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 studies are conducted to look at the long-term safety and effectiveness.
Who can participate?
Every clinical study 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 study, 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 study in the same manner. Some criteria may include:
- Age
- Health status
- Medical history
- Current medications
When creating a protocol for a clinical study, 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 study’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.
Questions About Clinical Studies
The following are some common questions about taking part in clinical studies:
1. Will I get a placebo if I am in a clinical study 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 studies only for people who have late-stage cancer, after all other treatment options have been exhausted?
Clinical studies 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 study?
Many clinical study 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 study coordinator which costs are covered, and which are not.
4. Will I be stuck in the study if I agree to participate and then change my mind?
As a participant in a clinical study, you have the right to leave the study at any time and for any reason.
5. Are there clinical trials available that are right for me?
Clinical studies 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 study?
If your doctor is not personally conducting a clinical study that you want to participate in, you may still continue to see him/her throughout the study, 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 can talk with the study doctor to be sure that he/she is in contact with your primary doctor regarding your participation in the clinical trial.
7. Can I participate in a clinical study if I don’t live near a major hospital?
Clinical studies 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 study participants today?
Today, clinical studies are conducted under strict guidelines to protect participants. These guidelines include oversight by independent review boards (IRBs), which ensure the study 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 and underrepresented communities in clinical research, and talk with your healthcare professional.
Finding a Clinical Study
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.
Click here for definitions of common gynecologic terms.
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