CLINICAL TRIALSWHAT EVERYONE SHOULD KNOW

What are Clinical Trials?  Why Do They Matter?

Clinical trials are research studies that involve people. Clinical trials for cancer investigate new treatments, prevention strategies, ways to manage symptoms, and ways to improve the quality of life of cancer patients.

Reasons to Consider Participating in Clinical Trials

• Opportunity to receive the newest treatments
• Improve treatment for future ovarian cancer patients
• Sometimes receiving more frequent care and testing, as the research team will watch you closely during the trial

 As with any treatment, it is important to carefully weigh the benefits and risks. There are possible risks or drawbacks that come with participating in a clinical trial, including:

• The side effects of new treatments being tested in clinical trials are not always known.
• You may need additional doctor visits and lab tests.
• You may not have a choice or know which treatment you will receive. This is because clinical trials are often randomized and blinded.

Randomization means that participants in the trial are randomly assigned to treatment groups, or in other words, the type of treatment you receive in the trial is not up to you or your doctor. Depending on the phase of the trial, the groups could also be different doses of the same treatment. If you are needing treatment for active cancer, all groups in the trial recommended will include a treatment, meaning there are no placebo only groups.

Blinding in clinical trials means not knowing the treatment a patient is receiving. In single-blinded trials, the patients do not know which treatment they are receiving. In double-blinded trials, neither the patients nor the doctors know who is receiving which treatment. This helps make sure that interpretations of how well the treatment is working or side effects aren’t biased by the knowledge of what treatment is being administered.

What are the Phases of Clinical Trials? 

• Phase 0 trials are small studies that explore if a drug works in humans the same way that it does in pre-clinical studies (experiments on cells and animals).
• Phase I trials determine what level of drug dose can safely be tolerated in humans, and to identify adverse (undesired) effects of the treatment. Phase I trials are generally not randomized or blinded.
• Phase II trials ask the question, “Does the new treatment dose and duration work?” These may be randomized and/or blinded.
• Phase III trials test to see if the new treatment is better than the treatments that are already available. These are also usually randomized and blinded.
• Phase IV trials follow people over a longer period of time after a treatment is on the market, and assess for adverse effects that might only be evident after many years.

Who Pays for the Cost of a Clinical Trial?

Your patient care costs, such as doctor visits, standard treatments, lab tests, and imaging are often covered by your health insurance. However, if you participate in a clinical trial, there will be research costs that are usually not covered by insurance. These are costs for the treatment being tested in the study, as well as any labs or imaging that are being done for research purposes only. These research costs, while not usually covered by insurance, may be covered by the sponsor of the trial.  

• If you have Medicare, routine costs of participating in the trial are covered. However, research costs may not be covered. Read more about Medicare and clinical trial cost coverage here.
• If you have Medicaid, coverage of routine costs of participating in clinical trials depends on what state you live in. As of 2020, Medicaid is covering some of these costs in Michigan.

Talk with your doctor, the research study coordinator, and your health insurance to figure out which costs will be covered. More details on insurance coverage and clinical trials can be found from the National Cancer Institute.

Where Can I Find Information on Clinical Trials?

One way to look for ovarian cancer clinical trials is the Ovarian Cancer Research Alliance’s Emerging Med application. This site is specific to ovarian cancer and is easy to use.

In addition, a database of clinical trials can be found at clinicaltrials.gov. Each study entry on the site contains information including the disease, treatment being tested, requirements to participate, locations where its being conducted, and contact information. You can search for trials based on subtype ovarian cancer, drug, or location.

When browsing clinical trials, be sure to look for the eligibility criteria each trial you are interested in. These requirements can be very specific in terms of age, tumor genetics, stage of cancer, and medical history.

Additional Information

• The National Cancer Institute has additional information about clinical trials for patients and caregivers, as well as series of short videos on clinical trials. Check out these links to watch their videos on joining a trial, phases, randomization, and the costs.
• A helpful discussion of common misconceptions of ovarian cancer trials can be found at the Ovarian Cancer Research Alliance.
• Check out the American Cancer Society for a detailed list of questions to ask before joining a clinical trial.