Participating in a clinical trial is the only way to access the very latest options, oftentimes years before they become available to other providers.
Every treatment that is now FDA-approved was studied in a clinical trial. Patients who enrolled in that clinical trial had access to that treatment before it was FDA-approved and widely available.
Benefits and risks of participating in a clinical trial
Each study is different, and you will learn more about potential risks and benefits of a specific study through the informed consent process.
Potential benefits include:
- Cancer care provided by top physicians in the field of cancer research.
- Access to new drugs and treatment methods before they are widely available.
- Close monitoring of your healthcare and any side effects.
- A more active role in your own health care.
- An opportunity to make a valuable contribution to cancer research.
When the information from a clinical trial show that the treatment being studied is more effective than standard treatments, it becomes the new standard of care.
Potential risks include:
- New drugs and procedures may have side effects or risks unknown to the doctors.
- New drugs and procedures may be ineffective, or less effective, than current approaches.
- Even if a new approach has benefits, it may not work for you.
Who is eligible for a clinical trial?
Each study’s protocol has guidelines for who can or cannot participate in the study. These guidelines, called eligibility criteria, describe characteristics that must be shared by all participants. The criteria differ from study to study. They may include age, gender, medical history, and current health status.
Eligibility criteria for treatment studies often require that patients have a particular type and stage of cancer, or even a specific genetic mutation. Enrolling participants with similar characteristics ensures that the results will be due to what is under study rather than other factors. In this way, eligibility criteria help researchers achieve accurate and meaningful results. These criteria also make certain that people who could be made worse by participating in the study are not exposed to the risk.
You could be eligible for several trials at the same time. Understanding what each study involves can help you make your decision. Ask your doctor to suggest a clinical trial that is best for your needs.
What is informed consent?
Informed consent is a process by which you learn the important facts about a clinical trial to help you decide whether to participate. This information includes details about what is involved, such as the purpose of the study, the tests and other procedures used in the study, and the possible risks and benefits. In addition to talking with the doctor or research nurse, you will receive a written consent form explaining the study.
If you agree to take part in the study, you’ll be asked to sign the informed consent form. However, signing the form does not mean you must stay in the study. You can leave the study at any time. The informed consent process continues throughout the study. If new benefits, risks, or side effects are discovered during the study, the researchers must inform participants, and you may be asked to sign new consent forms if you wish to stay in the study.
More questions?
Here are a few answers to some of the most common questions about clinical trials:
No. There are many different types of studies, and you don’t have to exhaust all other options. In fact, some studies are only open to patients who have not had previous treatments. Cancer clinical trials test new ways to treat, diagnose or prevent cancer or manage symptoms and side effects of treatment.
Yes, with their parents’ consent. Many clinical trials for adult patients are now available to our pediatric, adolescent and young adult patients. This means your child can have experimental cancer treatment right here in our facility, keeping you and your child closer to family, your support system and care team.
Roswell Park’s Experimental Therapeutics program, led by internationally renowned pediatric oncologist Clare Twist, MD, allows our pediatric patients access to novel therapies only available through early-phase clinical trials.
Most cancer clinical trials do not use placebos (study medication that has no active ingredients) unless it is given along with an active drug. It’s unethical to give someone a placebo if it would deny the person a chance to get a drug that’s known to work. Unfortunately, there are some types of cancer for which there are no proven effective treatments. In rare cases, testing a new treatment against a placebo might be needed to prove that the treatment is better than nothing at all. If a study uses a placebo at all, you will be informed before you give consent.
There are federal rules in place to help ensure the safety and ethics of clinical trials and to protect the rights and welfare of the people who participate in the trials. You will be protected through:
- The informed consent process where the study doctor will fully describe the study to you, including any risks.
- Careful review and approval of the clinical trial protocol by:
- Scientific experts who ensure the study is properly designed
- Clinical research professionals
- An institutional review board (IRB) which consists of doctors, health professionals and community members who review studies to protect the rights and welfare of study participants
- Throughout the study, ongoing monitoring occurs by:
- The IRB
- Data and Safety Monitoring Boards (DSMBs)
- The organization sponsoring the trial
- The research team
Every study is different as to the schedule of events, tests, procedures, clinic visits and more. While learning about the study, the time commitment will be explained thoroughly so that you understand the expectations and requirements.
The results of a study are generally not available until the study closes and the findings are analyzed and published. However, new or important safety information can and is shared throughout the study.
Taking part in a study is entirely voluntary, and you can leave a study at any time. Leaving a study early will not result in any penalty or loss of benefits to which you are entitled. However, if you do decide to stop participation, talk with your doctor first to ensure your safety as you withdraw from treatments.
Clinical trial costs are often covered by the sponsor of the study. Your health insurance may cover some costs, too, but there may also be some out-of-pocket costs. Be sure to ask the study coordinator about any costs associated with the trial and who is responsible for them.