Understanding Clinical Studies

Thanks to those who have participated in clinical studies, advances in treatment have been made possible for many types of cancers, including ovarian cancer. This gives doctors more options to choose from and increases the chances for better outcomes for their patients.¹

Phases of clinical studies²

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 different phases of clinical studies²:

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 cancer 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 available to patients, these studies are conducted to look at the long-term safety and effectiveness of a treatment.²

Who can participate?

Every clinical study starts with a protocol that is a detailed description for the study doctor of exactly how the trial should be conducted. It includes strict criteria for eligibility (inclusion criteria and exclusion criteria) and lets the doctors and nurses know exactly what procedures must be done at specific time points throughout the trial. Every doctor who conducts the clinical study, no matter where in the world they are located, conducts it in exactly the same way. Some criteria may include³:

Age
Health status
Medical history
Current medications

When a protocol is first being written, statisticians help figure out how many participants are needed for a particular clinical study in order to have enough information to be able to conclude whether or not the trial was successful.⁴

Why should I consider participating?

When considering whether to participate in an ovarian cancer clinical study, there’s a lot to think about, including deciding if a trial is right for you.

The informed consent form is a document that explains to the study participant what the clinical study will involve. This longer document includes information about the details of the clinical study, the study procedures involved, and the possible benefits and risks, etc. It will let the study participant know that she is free to withdraw her consent and drop out of the clinical 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.⁵

Misperceptions about clinical Studies

Following are some common misperceptions about clinical study participation:

1. I’m afraid of getting a placebo.
Although it is not common to use placebos in cancer clinical studies, they are sometimes used when no standard treatment would otherwise be given. They can also be used to compare standard treatment + a placebo with standard treatment + an experimental treatment. A placebo is an inactive substance (like a sugar pill) that is made to look just like the active medication.⁶

2. Clinical studies are only for those who have late stage cancer and are a last resort for people who do not have other treatment options.¹
Having access to clinical studies allows for the opportunity to receive potential new treatments before they are commercially available. Clinical studies are used by medical professionals to advance scientific knowledge, and frequently compare the current standard of care with a potential new treatment option.⁴ Often, drugs or treatments that are being studied in a clinical study may be approved for other cancers or even for a different stage of ovarian cancer. As such, a clinical study might be the right choice at different times throughout the course of your cancer treatment. However, it’s important to take into consideration the treatments and medications that you have already received as they may impact your ability to participate in a clinical study.

3. Clinical studies are expensive.
Most health insurance covers patient care costs associated with participating in a clinical study. The experimental drug is often provided free of charge by the company conducting the trial. Patient care costs would likely include study visits and any procedures that are being done strictly for purposes of the clinical study. Your study doctor can help you understand what costs, if any, you will have.⁷

4. I’m afraid that if I agree to participate and then change my mind, that I’ll be stuck.
As a participant in a clinical study, you have the right to leave the study at any time throughout the trial.⁵

5. If my doctor hasn’t talked to me about a clinical study, they don't think that one is right for me.
Clinical studies are offered throughout the United States and other countries around the world, and it is something to ask your doctor about when discussing your treatment options. If your doctor is not able to offer a clinical study, they may have information regarding a clinical study that may be right for you, or may tell you where you can find information on a clinical study that is being conducted.⁸

6. If I participate in a clinical study, I’ll have to switch doctors.
If your doctor does not offer a clinical study that you want to participate in, you may still continue to see them 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.⁴ You can talk with the study doctor to be sure that they are in contact with your primary doctor regarding your participation in the clinical study.

7. I don’t live near a major hospital so I can’t participate in a clinical study.
Clinical studies are offered in a variety of medical settings (including community hospitals and clinics), not just at major medical centers. Visit https://clinicaltrials.gov/ to find a clinical study that is being offered near you.⁸

Finding a clinical study

For more information about clinical studies in ovarian cancer, please visit https://clinicaltrials.gov/. The National Ovarian Cancer Coalition (NOCC), Ovarian Cancer Research Alliance (OCRA) and The Clearity Foundation have information available for the community.