About Clinical Research

Clinical research studies use human volunteers to better understand health and medicine. The people who take part in clinical research can be patients or healthy volunteers.

Clinical research includes studies to:

• Observe how a medical condition changes over time in a person, without treatment or with current treatments
• Develop new medicines or treatments
• Study the biology and genetic aspects of a disease
• Find out what causes a disease or side effect
• Study the long-term effects of treatment or a disease

There are 2 main types of clinical research:

• Observational studies: Look at data to find patterns that answer research questions
• Interventional studies: Test new ways to identify diseases (non-treatment studies), interventions such as exercise that can affect health, or treatment studies that test how safe and effective a drug or device is to prevent, control, or cure a disease

Our researchers, doctors, and care teams work closely with our patients and their families to develop cures and means of prevention for serious childhood diseases.

Patients may take part in clinical research because they can:

• Try a novel treatment if standard medical treatment did not work well for them
• Get new treatments not yet available to the public
• Help find new and better treatments
• Help physicians and scientists learn more about diseases

Find out more about clinical research on the Together by St. Jude™ online resource.

What sets St. Jude apart

St. Jude is a leader in developing groundbreaking clinical trials for serious childhood diseases.

Since it opened in 1962, St. Jude has played an important role in increasing the childhood cancer survival rate in the United States from 20 to 80%. St. Jude scientists, clinicians, and staff work together with our patients so discoveries can happen. St. Jude is the only National Cancer Institute-designated Comprehensive Cancer Center devoted solely to children.

Depending on the disease and where you live, patients may take part in clinical trials closer to their homes. Some clinical trials are offered through our St. Jude Affiliate Program. Children and their families can take part in clinical trials in an area that is more familiar to them with less stress from travel.

St. Jude partners with the World Health Organization (WHO) Global Initiative for Childhood Cancer. We hope to improve the survival of children with diseases worldwide through research and providing education and life-saving treatments.

Learn about many of the important discoveries by St. Jude researchers that have helped children with serious illnesses.

Types of clinical research at St. Jude

Our clinical research helps us learn ways to help patients survive and cope better. Our clinical trials study new treatments and better ways to use standard medical treatments. Information from these studies can help the whole family support their child.

Observational trials

St. Jude observational trials collect data about a patient’s medical condition without making changes to how the medical condition is treated. For example, a trial to study the sleep quality of children with cancer without giving medicines or other interventions to change sleep would be a observational trial.

Interventional trials

St. Jude interventional trials change something about how the medical condition is detected, followed, or treated. These trials are further classified as treatment or non-treatment:

• A treatment clinical trial studies a procedure, drug, or therapy that may provide medical benefit to patients.  

• A non-treatment trial does not provide a treatment. This kind of trial helps us learn about the disease and its impact.

Our patients get care and treatment that meets the highest standards. Treatment clinical trials have a series of steps (known as phases). They are followed to find out if a treatment is safe and works well. St. Jude offers phase 1, 2, and 3 clinical trials.

St. Jude also studies the health of our patients long after treatment ends. We study the long-term and late effects of cancer treatment. This information helps survivors lead healthier lives. Two important survivor studies include:

• Learn more about the St. Jude Lifetime Cohort Study (St. Jude LIFE) and see what we have learned so far.
• Learn more about the Long-Term Follow-Up Study, see examples of what we have learned so far and sign up for the LTFU newsletter.
• View results learned from a variety of St. Jude clinical trials.

Choosing clinical research at St. Jude

It is important to know the difference between standard medical treatment and treatment with a clinical trial.

Standard medical treatment:

• Has been approved by the U.S. Food and Drug Administration (FDA) or is commonly used in children and is recommended by a doctor
• Has benefits and risks that are known
• Can be changed by a doctor when needed

For clinical trials:

• The treatment may not yet be approved by the FDA.
• Patients must meet specific requirements.
• An approved plan (protocol) must be followed closely.
• If the person taking part in the trial desires or needs treatment that is not part of the protocol, they can stop taking part in the trial.

Following the protocol shows if a new treatment works and any side effects. These details help us find safe, effective treatments.

Some research treatments are not fully tested or approved, but they could lead to safe and effective new treatments. The treatment may become the new standard care for patients with that disease. Learn how clinical research studies have helped patients.

You may choose whether your child receives:

• Standard medical treatment
• Clinical research treatment
• Both medical and clinical research treatment

We encourage you to discuss these options with your child and allow them to ask questions of their physician. If your child is 18 or older, they will have the option to choose. The type of treatment depends on your child’s disease, age, health, and what treatment is available. Your child gets clinical research treatment if they meet specific guidelines, known as eligibility, and if the treatment is available at that location.

Safety in clinical research

St. Jude has several ways to protect patients in clinical trials. Clinical trials accept only people who would safely take part and may benefit from those trials.

St. Jude takes quality and patient safety seriously. We follow federal regulations and guidelines to protect the rights of patients in our research studies. A special board of independent experts, known as an Institutional Review Board (IRB), watches over each study. This board is made up of scientists, doctors, other health care professionals, and people from the community.

 This board:

• Reviews and approves all clinical trials
• Considers the benefits and risks of each study
• Periodically reviews clinical studies while they happen
• Makes sure that studies are safe and ethical

The board can approve studies or ask scientists to make changes. The IRB makes sure all patient volunteers are protected. 

St. Jude also has a Clinical Trials Scientific Review Committee. This group reviews the science of clinical protocols. They review why and how studies are done.

Privacy and data protection

St. Jude follows legal requirements to protect patients’ privacy, medical information, and patient data collected for research studies. Learn more about how we protect your child’s privacy in our privacy policy.

Balancing benefits and risks

If you want your child to be part of a research study, or if your child is 18 or older and wants to do so, you will meet a member of the clinical research team. They will tell you more about the study.

They will explain:

• Why researchers are doing the study
• What happens during the study, including any tests, treatments, and procedures
• How long the study lasts
• Benefits of taking part in the study
• Risks and side effects
• Other treatment options, including standard medical treatments
• How the study protects patient privacy.
• The contact person for the study so you can ask questions

Here is a helpful list of questions to ask the research team.

The research team member will tell you that it is your choice if your child takes part in the study. If your child is age 18 or older, they may choose. A patient does not lose any rights to standard treatment if they do not take part in a clinical trial.

Other health care professionals at St. Jude can also provide helpful information. You can talk with your child’s doctor, nurse, social worker, or other members of the care team.

You may also talk with the research participant advocate. This person is not part of the research study team. The research participant advocate can help answer questions about a patient’s rights in a research study and discuss problems or concerns. They can also share your input about the research with the IRB.

To reach the research participant advocate, call 901-258-3849 or 901-355-8242 or (toll-free) 1-866-278-5833, ext. 3849 or 8242.

Consent and assent for clinical research

To take part in a clinical study, St. Jude will ask 1 or both parents or legal guardians (or the patient if age 18 or older) to give written permission, known as informed consent.

Children and teens ages 7–17 may also be asked if they agree (assent) to take part. Children under age 7 are usually not asked if they agree, because they may not understand information about the study.

If a patient does not take part in a study, they may be able to still get treatment at St. Jude. We can also refer patients to a different hospital for treatment. In either case, the St. Jude staff will help you.

If you want your child to stop taking part in clinical research, you can remove your child from a research study at any time, for any reason. If your child is older than 18, they can stop taking part on their own.

Talk to your child’s doctor first about other options or treatments if you want to remove them from a study.