The Marco-Polo Studies

Information on Clinical Research Studies

1. Why do research in children?
2. Why are clinical studies in children important?
3. What is a clinical investigator?
4. What is an informed consent?


1. Why do research in children?

Medicines, devices, and treatments are often not tested in children. At nearly half of medical visits, children are given a medicine, and 70% of those medicines have only been tested in adults.

Children are not little adults. But without clinical research in children themselves, we have no choice but to treat them that way.

Doctors and nurses often give medicines to children even though they have not been studied and approved by the Food and Drug Administration (FDA) for use in children. This is known as "off-label" use.

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2. Why are clinical research studies in children important?

Clinical research in children helps us to treat our children like children, rather than as little adults, in several ways:

• it may uncover the best dose of medicines to prevent harmful effects or under-treatment

• it may lead to the development of chewables, liquids, or tablets that are easier for children to take, yet still safe

• it may result in treatments for problems that occur only in children, like prematurity

• it may lead to treatments for diseases or conditions that occur in both children and adults but that act differently in children and adults, like arthritis or heart disease

• it may result in treatments for new or existing diseases that improve the health of children in the future, like vaccine studies that were done years ago and help children stay healthier today

• it may help us understand how medicines affect children's brains and bodies as they grow and develop.

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3. What is a clinical investigator?

A clinical investigator is a medical researcher who is in charge of conducting a clinical trial and ensuring the well-being of study volunteers. Researchers are usually doctors, nurses, pharmacists, or other health care professionals

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4. What is an informed consent?

Anyone entering a clinical clinical research study in the United States is required to sign a form indicating that they understand what will happen to them during the clinical research study. If the patient is a child, a parent or guardian as well as the child must sign the form. This form will tell you what study drugs will be given, what kind of problems might occur,Marco-Polo Research Studies Spy Glass and Captain's Wheel and what other treatments might work for your condition. The amount of help expected from the clinical research study will be given if any. The informed consent form also indicates which costs are covered by the clinical research study and which must be paid by you (or your insurance).

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