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Guide to Clinical Studies

Learn more about clinical research at Lurie Children’s and Manne Research Institute below. 

What Is Clinical Research?

When doctors and scientists work together to understand diseases and to search for new and better medicines and other treatments by studying patients, they are performing clinical research. Patients who choose to take part in the clinical research study are called “participants.”

Types of Clinical Research

There are two types of clinical research: observational and interventional. 

Observational research involves carefully gathering information about the participant by looking at their medical records or taking information from them over an extended period of time. These research data are collected by observing the participants, rather than studying new medicines or treatments.

Interventional research involves adding something new or different to the usual treatment. This may include giving the participant a drug or using a device that is different than the regular care they would receive. Sometimes this is an experimental drug or device that is not yet approved for widespread use, and sometimes it is a new way of using a drug or device that is already in use, or comparing two different treatments for the same disease. The results of this intervention are then followed to determine its effectiveness and its safety. 

What Is a Clinical Trial?

A clinical trial is a kind of interventional research study that often involves testing new medicines to see if they work better than the current ones. Some clinical trials may take place only at Lurie Children's. At other times, Lurie Children's may be part of a multi-center clinical trial, in which a large number of investigators study a new medicine at the same time.

Why Should My Child Participate in a Clinical Trial?

Sometimes clinical trials are testing drugs already approved for use in adults to find the best dose for children. This helps to ensure that the medicine is strong enough to do the job, but safe enough to not cause any bad side-effects in children who are still growing and developing. Other times treatments are being tested for conditions that start during childhood. Finally, some clinical trials test for ways to make medicine easier to take by making it chewable or better tasting.

What Guidelines Do You Have to Ensure Patient Safety?

A child will not be enrolled in a clinical trial without the permission of her parents. There are very strict laws that govern research in humans. Everyone who is interested in participating in a clinical trial should ask questions about the study to make sure that the study procedures and risks are acceptable to them. Both the child and the parent need to be comfortable with the research. We use the following policies to make sure that children and families are well informed and that their rights are protected:

Provide Information About Risk Factors

Researchers will always tell participants about the study and let them know things like how long it will last, what the researchers are trying to learn and what risks may be involved in the research study.  

Keep Your Information Private

We never tell anyone the names of the people who are participating in a clinical trial and we make sure that all of the information we gather for a study is never disclosed to those outside the research team unless the participants give their permission.

Receive Your Permission

No one is ever forced to take part in clinical research. People who choose to participate in a study can choose to stop participating at any point during the study. We are never angry or upset if you choose not to participate.

Make Sure Patients Meet the Study’s Criteria

Not everyone can be accepted to participate in clinical research. Patients who want to participate may not meet all of the study’s requirements. Clinical research may require that participants be a certain age, have a certain medical condition or be taking certain medication. Sometimes clinical research requires healthy children too, so that researchers can compare them to children with an illness.

Obtain Institutional Review Board Approval

At Lurie Children’s, we are extremely careful about how we do our research. A panel of experts from our Institutional Review Board (IRB) monitors each step of the study to make sure it is as safe as possible. Every bit of information we gather is carefully analyzed by doctors, scientists and biostatisticians.

Clinical research is one of the most important ways to improve the care and treatment of our patients. Every research study teaches us something that takes us a step closer to finding cures for many diseases and disorders that affect children.