Joining A Greater Cause

While any investigational treatment involves some risk, every clinical trial has a detailed plan reviewed by many experts to make sure it is as safe as possible. When you participate, you are protected from any unnecessary risk.

Experts from federal health agencies and the Institutional Review Board (IRB) must review and approve all trial plans. They will not approve a trial plan if the potential risks to a participant are too high. Any potential risk must be explained to you during the informed consent process before you agree to be in a clinical trial. Doctors will monitor your health throughout the trial, and you can leave the trial at any time for any reason.

While any medical treatment involves some risk, every clinical trial has a detailed plan reviewed by many experts to make sure it is as safe as possible. When you participate, you are protected from any unnecessary risk.

Experts from federal health agencies and the Institutional Review Board (IRB) must review and approve all trial plans. They will not approve a trial plan if the potential risks to a participant are too high. Any potential risk must be explained to you during the informed consent process before you agree to be in a clinical trial. Doctors will monitor your health throughout the trial, and you can leave the trial at any time for any reason.

Every clinical trial is led and supervised by doctors, who we call Principal Investigators and Sub-Investigators. If you have a regular doctor, you can continue to see them as usual.

No, you don’t need health insurance to participate in a clinical trial.

In a clinical trial, there are usually no costs for tests, doctor visits, and treatments related to the study.

Typically, you will be paid for your time and any travel expenses when you participate in a clinical trial. You may also get assistance in identifying and enrolling in financial assistance programs, for those who qualify.

Some trials only require short visits every few weeks, while others may include weekly visits or even overnight stays. We’ll let you know how many visits and the length of time required to complete the trial before you sign up, so you can decide if the trial fits into your schedule.

Yes, even after you enroll, you can leave a clinical trial at any time, for any reason.

In a clinical trial, you may receive care and treatments related to the study, like doctor visits, tests, and medications.

Every trial has specific criteria for eligibility. The trial team will determine whether or not you meet those criteria.

There are many reasons to join a clinical trial. Joining a clinical trial could be a great way to learn about your disease or condition, it may give you access to new investigation treatments and additional medical attention from the study care team who can provide additional tests, check-ins, and follow-ups at no cost to you. For many, joining a clinical trial is about helping researchers find new ways to prevent or treat disease and to benefit future generations.

You have many rights during a clinical trial, including the rights to:

• Leave the trial at any time, for any reason
• Ask questions about any part of the trial
• Be informed on what the goal of the study is and what you can expect
• Know who will have access to information about you
• Be aware of all the risks and benefits
• Keep your identity confidential and understand how your information is being protected

Every clinical trial has requirements, called eligibility criteria, that will either include or exclude you from being able to participate in a trial. The study team will let you know if you are eligible to participate in a trial. If you don't qualify for one trial, you may still qualify for a future trial.

A placebo is a pill or other substance that looks like an active treatment but doesn’t have any actual treatment in it. It could be a sugar pill or a tablet that contains the same ingredients as the potential new treatment, except for the active ingredient.

Placebos are only used when receiving a placebo would not be dangerous to anyone in the study, and are never used if it would put someone at risk by not allowing them to have effective medicine. You’ll only be considered for a trial that uses a placebo when it’s safe and medically appropriate.

If a placebo is being used in the trial you’d like to participate in, you will be informed ahead of time. During the trial, you won’t know whether you receive the active treatment or the placebo. This is called blinding and is an important aspect of scientifically sound research, for certain types of studies.

Not every trial uses placebos. In cancer clinical trials, placebos are rarely used. If they are, participants who receive the placebo will not have to stop their current cancer treatment.

In any clinical trial, the kind and amount of care you receive depends on the specific study. You can ask any questions about the use of a placebo when you meet with your Patient Educator before the trial begins.

In most trials, you’ll continue to see your regular doctor. This is because most clinical trials focus on a specific medical condition and don’t provide long-term healthcare once the trial is complete.

You don’t need a doctor to participate in a clinical trial. During the trial, your care team will include study doctors as well as other dedicated nurses, medical specialists and support staff who can guide you.

Many clinical trials offer the option to maintain your existing treatment. You can discuss any current medications you are taking with the study team before you begin a trial.

Most clinical trials are designed to study the effects of an investigational treatment, so usually they will not require any changes in daily activities or diet. However, in some trials, you may have to follow a particular diet or exercise routine. The study team will discuss the requirements of a particular trial before you join.

Children’s bodies work in different ways than adults, so there is a need to test if medicines are safe and effective for children. Many children participate in clinical research, and as a result, treatment options for pediatric patients continue to improve. When clinical research involves children, parents and guardians are fully informed and involved throughout the entire process.

Yes, some clinical trials include healthy people. Healthy volunteers can help researchers understand the effects of certain treatments like vaccines.

Your information is protected by privacy laws, like the Health Insurance Portability and Accountability Act (HIPAA). HIPAA mandates privacy protections for any health information that could identify you, such as your full name, diagnosis, or treatments you receive during a trial. The informed consent process will tell you how your information will be protected. Our staff go through advanced training on the security of medical records.

In addition, our research teams ensure all members follow Good Clinical Practice (GCP) guidelines, an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial participants.

We want clinical research to be available to everyone and are working with local communities and doctors to build out more locations for you to access clinical trials. If you decide to join a trial in your area, we can assist you in finding transportation to and from any visits. In some trials, home and virtual visits are available too.

Once the trial is complete, the treatment and study results are submitted to the FDA for review. If approved, the investigational treatment becomes available to those who need it.

Often participants can continue to have access to the trial drug even after the study is complete. Before you start a trial, your Patient Educator will discuss these details with you during the informed consent process.

Yes, you will be informed of the results of the trial you participate in. Without you, new treatments wouldn’t be available for others, so sharing the results helps you understand the positive impact you’ve made not only for yourself and your family, but for your community too.