Joining a clinical research study helps physicians and scientists learn more about specific pediatric diseases, helps discover new therapies and ultimately improves care for children. Always feel free to speak to a member of the research team about any questions or concerns you may have. If they don’t have the answer, they will be happy to find the answer for you.

More information on clinical trials and children:

• National Institutes of Health – Kids and Research
• American Academy of Pediatrics – Should my child join a clinical trial?
• U.S. Food and Drug Administration – Would your child benefit from a clinical trial?

If you want to learn more about current or past clinical trials across the United States, visit ClinicalTrials.gov.

We have two locations in downtown Louisville, Kentucky: Norton Children’s Hospital, 231 E. Chestnut St.,  where we enroll hospitalized patients in clinical trials. Most outpatient studies are conducted at the Novak Center for Children’s Health, sixth floor, at 411 E. Chestnut St.

• Norton Children’s Hospital:  The hospital is located at 231 E. Chestnut St., with a parking garage on corner of Floyd Street and Abraham Flexner Way, on the back side of the hospital. See a map of the area. You will be reimbursed for parking expenses.
• Novak Center for Children’s Health: Parking is available at the UofL Health parking garage located at 414 E. Chestnut St. Valet parking is available at the main entrance for a $10 fee. You will receive reimbursement for self-park, but not for valet parking.

A research nurse is available via a 24-hour pager. If you have a question, medical issue while on a study or emergency, call (502) 629-5820, option 5. This will connect you to our 24-hour line. Leave a voicemail, and the nurse will return your call shortly.

• From Norton Children’s Hospital, walk across the second-floor pedway to Norton Hospital and visit the cafeteria on the first floor.
• From the Novak Center for Children’s Health, there is a Panera on the first floor of the UofL Physicians adult outpatient center, which can be accessed through a pedway or across the driveway. There also is a cafeteria in the basement of the ambulatory care building, which can be accessed either by pedway or short walk outside.
• Delivery is available to either facility from several nearby restaurants.
• Food trucks often are parked outside Norton Children’s Hospital on Chestnut Street and/or on Preston Street outside Novak Center for Children’s Health.

Yes, if you would like them to know. We want to make sure your child’s primary care provider is aware of your participation and will notify them after you sign the consent to take part in the study. We are happy to update any specialists seen by your child to ensure participation in the study will not conflict with other treatments. Your child’s health and well-being is our top priority.

If you would like to keep your child’s participation private, we will not notify providers. Confidentiality is very important to our team.

The provider who was caring for your child’ diagnosis will still be involved. We are used to working closely with pediatric specialists. Being involved in a study may change the treatment your child receives, but at the end of the study we will ensure your child has appropriate follow-up appointments to continue regular care and treatments as necessary.

Your child’s regular care will remain the same, as it currently is, if you decide not to join the study. Your child’s medical care and safety is still our priority, and we want to ensure their health is being taken care of.

No, your insurance should not be billed for research procedures. If you receive a bill or explanation of benefits (EOB) from your insurance company, let us know. If the study your child is participating in requires a procedure where insurance could be billed, your coordinator will review this with you during the consenting process.

Most studies are performed at no cost to patients or their caregivers. Depending on the study, your research coordinator will discuss any potential charges ahead of time.

It is very important to keep track of all study medications, supplies and forms to ensure study quality. However, we understand that occasionally accidents happen. If you misplace medication, contact your study coordinator immediately so they can replace the medication or supplies and get you back on track. Study medications must be tracked to ensure your child is getting the appropriate treatment. All study medications and supplies generally must be returned at the next scheduled visit, even if the bottles are empty.

Your child’s safety and well-being are our top priority. Each study has a list of prohibited medications. Before taking a new medication, it is important to notify your coordinator of what you have been prescribed. We want to make sure there are no medication interactions that could be a problem for your child.

Part of being in a research study is looking for side effects of medications. We want you to report any issues your child has so we can determine if it is related to the study treatment. Sometimes we know it may seem silly to report a headache or the common cold to the study team, but it may be more important than you think. We would rather have too much information than not enough, so we know your child is getting the best care possible.

Every study is different. Usually, the trial consent form will include the number of visits your child will be expected to attend. The study coordinator will go over this information with you during the consenting process. It is important that you understand the expectations of the study and your requirements before it begins. Sometimes a study can be short, needing only two or three visits that may be completed within a week. Some studies last for years, with study visits weekly or every couple of months. Discuss this with your study coordinator and they will be happy to explain the expectations for any studies you may be interested in. Visits can be short, such as about 30 minutes, or they can be longer, such as a few hours or even overnight.

Every study is different and is looking for different information. Some studies may involve collecting vital signs (heart rate and blood pressure), while some studies may involve drawing blood and/or imaging exams, such as X-rays. Your study coordinator will review this information with you before beginning a clinical trial.

This is a myth about clinical trials and research studies. We don’t want anyone to feel like we are “testing” drugs on them or their child. Our job is to make sure that the medications we are researching are the best, most effective dose for your child. All studies must be approved by a human subject’s protection office and our Institutional Review Board to make sure the risks are minimal and we are not putting your child (medically or ethically) in harm’s way.

You or your child may or may not directly benefit from research studies. Your participation may provide additional information that could benefit other children in the future. Some medication studies may offer a placebo, or fake drug, while some may offer a new investigational drug that we hope is better than the current options available. Because these medications are still being studied, we cannot guarantee your child will respond to the treatment. Your child’s health and safety are always our priority, and we want to make sure they are being given the most appropriate treatment.

There are always risks involved with any medication and/or medical device. Until a medication or device is studied, we cannot guarantee that we know every potential risk factor. Allergic reactions are a possibility. All our research studies are reviewed by our Institutional Review Board to ensure that they have minimal, if any, risk(s) involved for potential participants. It is important that you know the risks involved with the research study, so you are able to make an educated decision regarding your child’s participation. Your study coordinator will review any known risks with you before beginning a clinical trial.

We hope research visits are as nonintrusive as possible in your life. If we can accommodate schedules, we absolutely try to combine visits or try to schedule the visits back-to-back as much as possible.

Children ages 7 and older are asked to sign a simplified version of the consent form, called an assent. Out of respect for children, we want to make sure they consent to what we are asking them to do. For example, if a child is terrified of blood draws and the study they are participating in will need them to get a blood draw often, they may not want to do the study if they don’t see an immediate benefit. We are happy to talk with you and your child regarding how we can make clinical trials as comfortable as possible.