CLINICAL TRIALS

What clinical trials do and why they're needed

Clinical trials test medicines, vaccines or medical devices that are in development to see to see if they're safe and effective. It may take many clinical trials all around the world to understand which treatments work and how they work. New treatments are tested in clinical trials before government agencies can approve them for doctors to prescribe to people.

Most clinical trials are classified as a Phase I, Phase II or Phase III trial. In addition, after a treatment has been approved and is being offered to patients, the drug’s maker may study it further in a Phase IV trial.

Phase I: Safety

Phase I trials test therapies that have already shown effectiveness in the laboratory. The goal of Phase I studies is to determine safety, the appropriate dose and how the treatment is processed inside the body. Researchers also look for an initial signal of effectiveness in treating the tumor. Generally, the best way to administer the drug (by mouth or injection) has already been determined. Participants are closely monitored for side effects and doses are adjusted as needed. Some trials are combinations of Phase I and II.

Phase II: Efficacy

Phase II trials involve a larger number of participants, usually between 25 and 100 women. These trials continue to test the safety of the drug, or a combination of drugs, and evaluate how well the new drugs(s) work. Phase II trials usually focus on a particular type of cancer, such as ovarian cancer, and are designed to learn more about side effects of the drug(s).

Phase III: Comparison

Phase III trials test how a new drug or combination of drugs, or a new surgical procedure, compares with the currently approved standard treatment. In many cases, for example, trials compare the approved, standard chemotherapy, versus standard chemotherapy plus an additional treatment. Phase III trials are randomized, meaning that women have an equal chance of being assigned to either the new therapy group or the approved treatment group. In order to prevent bias, the participant and the doctor administering the treatment may not know to which treatment group the woman has been assigned.

Phase IV: Expansion

Phase IV trials take place after a therapy has been approved by the FDA. The drug manufacturer may continue, or be required by the FDA, to continue to test the drug over a longer period of time with a larger number of participants to determine long-term safety and cost effectiveness, and to improve the management of side effects. standard treatment vs. new treatment Phase III trials often enroll large number of women (between 100 and 1,000 patients) and are used to determine if the new treatment is more effective than the standard of care. These trials may be conducted in doctors’ offices, clinics and cancer centers nationwide, or even worldwide. If the new therapy is found to be effective and meets safety requirements, an application will be submitted for FDA approval.

Our goal to:

• Help save and improve lives

• Learn more about how our bodies respond to investigational treatments

• Find new and better ways of advancing science

Reasons to consider participating in a clinical trial

Trial participants will:

• Learn more about their health condition and take an active role in their own health care

• Help future patients by advancing medical research

You're never required to join or complete a clinical trial. Trials are volunteer-only, and you may leave a trial at any time.

Risks include:

• Unwanted side effects

• The treatment may not work

• You may not receive the new treatment being studied

• Extra time and attention needed for trial-related tasks and visits

HOW DO I KNOW A CLINICAL TRIAL IS RIGHT FOR ME?

Once you find a clinical trial that you are considering, you will need to talk to your doctor or clinical trials staff who can answer questions as they relate to your particular case.

Here are some questions to ask:

• What kinds of therapies, procedures and/or tests will I have during the trial?

• How will the trial affect my current treatment plan and daily life?

• Will I be taken off my current treatment plan or will I continue to take my regular medications while in the trial?

• Where will I receive my cancer care and who will be in charge of my care?

• If the person in charge of my cancer care during the trial is different from the doctor from whom I receive my current care, what will be the communication/interaction between the two?

• What are the benefits to my treatment offered by this particular trial?

• Are there any potential side effects or risks connected to this particular trial?

• Who do I call if I have questions about the trial once I am enrolled?

• How can I drop out of the trial if I don’t like it or change my mind?

• Will my insurance cover the costs of my participation?

• Will I have any out of pocket expenses?

• How long will the trial last?

• What is the purpose of the study—is it to determine the effectiveness of a new drug or a new combination of drugs/treatment?

• Who is the sponsor of the study?

• Who has reviewed and approved the study?

• How are study results and participant safety being checked while the study is underway?

WHAT ARE CLINICAL TRIALS?

Clinical trials are research studies that investigate how treatments affect a patient’s disease. They play an important role in developing new therapies for cancers, including gynecologic cancers. Before any treatment can be tested in humans, it must show positive results in the laboratory and/or in animal studies. Gynecologic cancer clinical trials are necessary to determine whether new treatments developed in the laboratory are beneficial to women living with a gynecologic cancer. There are two primary entities devoted to ensuring that clinical trials are conducted in an ethical and scientific manner. The United States Food and Drug Administration (FDA) monitors clinical trials to protect participants and the general public. In addition, institutions conducting clinical trials must establish an Institutional Review Board (IRB) which is a committee that has been formally designated to approve, monitor and review biomedical and behavioral research involving humans. A clinical trial is one of the final stages of a long and careful gynecologic cancer research process. The research usually includes new drugs, new treatment combinations, or new medical devices or technologies. Most clinical trials are classified as a Phase I, Phase II or Phase III trial. In addition, after a treatment has been approved and is being offered to patients, the drug’s maker may study it further in a Phase IV trial.

Phase I: Safety

Phase I trials test therapies that have already shown effectiveness in the laboratory. In Phase I studies, a small group of patients, usually between 20 and 40 women, are tested with the new treatment. The goal of Phase I studies is to determine safety, the appropriate dose and how the treatment is processed inside the body. Researchers also look for an initial signal of effectiveness in treating the tumor. Generally, the best way to administer the drug (by mouth or injection) has already been determined. Participants are closely monitored for side effects and doses are adjusted as needed. Some trials are combinations of Phase I and II.

Phase II: Efficacy

Phase II trials involve a larger number of participants, usually between 25 and 100 women. These trials continue to test the safety of the drug, or a combination of drugs, and evaluate how well the new drugs(s) work. Phase II trials usually focus on a particular type of cancer, such as ovarian cancer, and are designed to learn more about side effects of the drug(s).

Phase III: Comparison

Phase III trials test how a new drug or combination of drugs, or a new surgical procedure, compares with the currently approved standard treatment. In many cases, for example, trials compare the approved, standard chemotherapy, versus standard chemotherapy plus an additional treatment. Phase III trials are randomized, meaning that women have an equal chance of being assigned to either the new therapy group or the approved treatment group. In order to prevent bias, the participant and the doctor administering the treatment may not know to which treatment group the woman has been assigned.

Phase IV: Expansion

Phase IV trials take place after a therapy has been approved by the FDA. The drug manufacturer may continue, or be required by the FDA, to continue to test the drug over a longer period of time with a larger number of participants to determine long-term safety and cost effectiveness, and to improve the management of side effects. standard treatment vs. new treatment Phase III trials often enroll large number of women (between 100 and 1,000 patients) and are used to determine if the new treatment is more effective than the standard of care. These trials may be conducted in doctors’ offices, clinics and cancer centers nationwide, or even worldwide. If the new therapy is found to be effective and meets safety requirements, an application will be submitted for FDA approval.

What clinical trials do and why they're needed

Clinical trials test medicines, vaccines or medical devices that are in development to see to see if they're safe and effective. It may take many clinical trials all around the world to understand which treatments work and how they work. New treatments are tested in clinical trials before government agencies can approve them for doctors to prescribe to people.

Clinical trials are a key part of the drug development process and our goal to:

Help save and improve lives

Learn more about how our bodies respond to investigational treatments

Find new and better ways of advancing science

Reasons to consider participating in a clinical trial

Trial participants will:

• Learn more about their health condition and take an active role in their own health care

• Help future patients by advancing medical research

You're never required to join or complete a clinical trial. Trials are volunteer-only, and you may leave a trial at any time.

Risks include:

• Unwanted side effects

• The treatment may not work

• You may not receive the new treatment being studied

• Extra time and attention needed for trial-related tasks and visits

HOW DO I KNOW A CLINICAL TRIAL IS RIGHT FOR ME?

Once you find a clinical trial that you are considering, you will need to talk to your doctor or clinical trials staff who can answer questions as they relate to your particular case.

Here are some questions to ask:

• What kinds of therapies, procedures and/or tests will I have during the trial?

• How will the trial affect my current treatment plan and daily life?

• Will I be taken off my current treatment plan or will I continue to take my regular medications while in the trial?

• Where will I receive my cancer care and who will be in charge of my care?

• If the person in charge of my cancer care during the trial is different from the doctor from whom I receive my current care, what will be the communication/interaction between the two?

• What are the benefits to my treatment offered by this particular trial?

• Are there any potential side effects or risks connected to this particular trial?

• Who do I call if I have questions about the trial once I am enrolled?

• How can I drop out of the trial if I don’t like it or change my mind?

• Will my insurance cover the costs of my participation?

• Will I have any out of pocket expenses?

• How long will the trial last?

• What is the purpose of the study—is it to determine the effectiveness of a new drug or a new combination of drugs/treatment?

• Who is the sponsor of the study?

• Who has reviewed and approved the study?

• How are study results and participant safety being checked while the study is underway?