Q & A About Pediatric Clinical Studies

Q & A about studies

Every research study is different. You’ll find answers to some questions parents and children often ask when thinking about enrolling below. These answers are brief, general explanations of typical research practices. Before enrolling in a specific study, you will receive comprehensive information and have many opportunities to have all questions answered to your satisfaction.

Why is research with children important?

Most medications doctors prescribe were tested and approved for adults. Such treatments may not work the same way in infants, children, or teens. Children are constantly growing and developing. There are a host of similar reasons for conducting research with children.

Doctors undertake studies to: 

What is a clinical study?

A clinical study evaluates the effectiveness and/or safety of new treatments or medical devices on patients with a known health problem. A study might also test medical procedures (better surgical techniques, etc.).

The goal is to better understand, diagnose, treat or cure a disease or condition. Well-designed, closely monitored studies are often the fastest, safest way to find new or better therapies. When a study shows a new therapy is effective and safe for disease prevention, treating a specific medical condition, or provides treatment benefits, the Food and Drug Administration (FDA) approves the medicine or device for all doctors to offer to their patients.

How do I know if my child qualifies for a study?

Every study specifies who can participate. Known as “inclusions” and “exclusions,” these factors are determined by the specific illness or medical condition and a child’s age, weight, medical history and other traits relating to the study’s goals.

Some studies need healthy volunteers, such as tests for new vaccines. If you are interested in a study but your child is ineligible, explore whether an alternate study may benefit your child’s health.
 

What is a study protocol?

Doctors conducting a clinical study must follow detailed pre-approved procedures and guidelines. For instance, the protocol may specify how often a patient must take a specific dose of medicine.

The protocol also includes a schedule for any special tests, X-rays, or examinations that are required. Sometimes a protocol may also alert patients and their parents to watch for potential side effects.

This written “recipe” forms the foundation for all protocols. It ensures every study physician follows identical practices no matter where the study takes place.

How can I weigh the benefits and risks of placing my child in a study?

There is no one answer to this question. Some things to consider include:

You should also seek advice from your pediatrician or family doctor. Talk it over at home. If you have more questions, continue to ask the doctors or study team members who are conducting the research. They encourage you to ask questions at any time throughout the course of your child’s study participation. If their response is unclear to you—ask them to provide a different explanation.

Before putting your child in the study, you must feel at ease about the goals, requirements, and potential treatment results. Having all your questions answered is critical to reaching such a comfort level.

Can my child leave a clinical study after it begins?

Yes. You may remove your child from the study at any time.

Are there additional charges or financial considerations?

Sometimes a study sponsor may reimburse expenses such as travel, meals, and similar costs that could be required for being in the study. Each study varies. You should also find out what insurance may or may not cover.

Who sees my child's medical records?

Research investigators collect only the data or patient information needed to meet the study goal. Investigators and research sponsors (governmental agencies, universities, healthcare companies, etc.) must adhere to strict guidelines to ensure a child’s medical and research information stays confidential.

Known as “Protected Health Information,” this includes items such as name, address, medical record number, and similar individual data. Sometimes medical journals publish study findings to inform the wider medical community. However, patient names or other identifiable information is never published without the parent’s permission.


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