Frequently Asked Questions

Informed consent is a very important part of participating in a clinical study. Before you enroll in a study, you will always talk with our research navigator to learn all about a clinical trial before you decide to take part in it and have the time to have all your question answered. We call this Informed Consent. After you understand why the trial is being done, how it is being done, what the risks are and how you could benefit from taking part, you may choose to sign an Informed Consent document. The purpose of Informed Consent is to make sure your safety is the most important part of the clinical trial. We want you to understand the trial and your part in it before you agree to take part.

Parkland takes privacy very seriously and wants to protect you and your personal information fully. The Health Insurance Portability and Accountability Act (HIPAA) is a federal law that protects your health information from being disclosed without your knowledge or consent. The Genetic Information Nondiscrimination Act (GINA) protects you from being discriminated against based on your genetic information, in both health insurance and employment. Researchers are required to follow strict guidelines to make sure that you are safe. Many clinical trials are supervised by a Data and Safety Monitoring Committee, who frequently check the progress of the trial.

What are some of the reasons you might want to take part in a clinical trial?

• You have a chance to help other patients get better cancer treatment in the future. The treatments and cures for diseases that we have today only came to be because of past clinical trials. When you take part in a clinical trial you are part of the research that will one day help us cure cancer.
• You may be able to have to a new treatment that is only available in the research setting: A new treatment may be more effective and have fewer side effects than your current treatment. Sometimes people taking part in a clinical trial can get treatments that are not yet available outside of the trial.
• Treatment may be free or low cost: Some clinical trials may pay for part or all of the treatment, check-ups, transportation, and other expenses during the study. Make sure you know what you are going to have to pay for before you agree to be part of the clinical trial.
• Your health will be closely monitored: By taking part in a clinical trial, your health will be cared for by a large team of medical professionals, both at Parkland and UTSW.

What are some of the drawbacks of taking part in a clinical trial?

• The new treatment may not improve your health: While all clinical trials hope to better the health of the patients taking part in them, we cannot promise the new treatment will be better than your current treatment.
• Possible side effects. Since the purpose of interventional clinical trials is to study how a new treatment works in the body, we may not know ahead of time if it might cause severe side effects.
• Insurance companies may not cover it. Depending on the clinical trial, your insurance company may not cover extra costs that have to do with the clinical trial.
• More frequent testing and visits. Some clinical trials require the patients taking part to be tested and screened more often to closely monitor how they are doing with the treatment.

Not all clinical trials are suitable for all patients. One trial may be safe for one patient but not for another. Each clinical trial has strict rules that doctors must follow to decide who can join the clinical trial. These rules are called eligibility criteria. The eligibility criteria include information about you and your general health and are also specific to your cancer. This can include the type and stage of your cancer, and other treatments you may have had.

Yes. In cancer clinical trials, everyone receives at least the care you would have gotten for your cancer even if you were not enrolled in the clinical trial. Some trials want to find out if a new treatment is better than the standard treatment. Other trials are testing to see if treating a patient with usual care and a study medicine together is a better treatment option. In these trials, it may be that you receive the usual care and a placebo medicine (usually a sugar pill) while other participants receive the usual care plus the study medicine. These trials would be considered “placebo-controlled”. If you are asked to join a trial that is described as “placebo-controlled”, you should feel free to ask questions about how this will change what you might usually receive if you were not in the trial.

It depends on the clinical trial. At Parkland, you will be in touch with Financial Services who will inform you of any costs you will need to pay or how you may receive any payment. Some clinical trials pay for the cost of the trial, but not all clinical trials pay you to take part. Ask your patient navigator questions about what parts of the study will be paid for by the study.

Depending on the clinical trial, some may cover the transportation cost of your visits. For those that do not, our Social Work office will help you find another way to meet your transportation needs.

After your treatment is complete, researchers will continue to carefully monitor your health for a period of time depending on the study. This may include our team reaching out to schedule follow-up visits and testing.