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For Patients and Families
You may not think about it, but every medication you receive is the result of a medical advance made possible through research. And at the heart of treatment research are clinical trials that test new medications, devices, or interventions in an attempt to better understand and treat a disease or disorder. At Kennedy Krieger Institute, our researchers have long been conducting clinical trials to test promising new treatments for patients. But with the expansion of the Clinical Trials Unit, we now have a center of excellence to conduct, coordinate, and complete them.
What to Expect During a Clinical Trial
Each individual participating in a clinical trial at Kennedy Krieger receives expert assessment, careful screening, and diligent monitoring throughout the entire course of the study. All participants, or their parents or guardians, are informed about the details of the study and any known risks or potential benefits before they agree to participate in the trial, a process known as informed consent.
All research is undertaken with the utmost care and concern for the safety, health, confidentiality, and privacy of each participant. Every clinical trial is approved and monitored by the Johns Hopkins Institutional Review Board—an independent committee that ensures the trial is ethical and that the rights of participants are protected—and many are also monitored by the Food & Drug Administration. We monitor each participant closely via multiple on-site clinic visits, and each participant is provided multiple contact numbers if there are concerns in between visits.
- The first step in a clinical trial is to establish whether you are eligible to participate in the study (this is called ‘screening’). Depending upon the inclusion/exclusion criteria of the study, a clinical research coordinator or the principal investigator will determine if you can participate in the study. If you are not eligible, the representative may take down your details as a prospective candidate for any future clinical trials or refer you to other ongoing clinical trials.
- If eligible, you will be guided through the process of what will happen during the course of the study, the benefits you may receive (such as compensation of time and travel), and any restrictions you may have to follow. The risks involved in the study will also be explained to you at this stage.
- Once the clinician is sure you understand all details of the study and are still willing to participate in the trial, you will be asked to sign a consent form declaring that you understand the clinical trial and are ready to participate and undergo all the procedures required (a process known as informed consent).
- Following this, you will be given specific instructions and schedules for the trial (the trial requires periodic visits, called study visits). Any required doses of medication will be handed out with clear written instructions.
- You will be monitored carefully throughout the trial. Some of your visits may involve blood draws, or urine to be sent to the lab. These visits may also include physical exams, and questions by the physician or an experienced rater. There could be some testing or questionnaires to fill out for both the participants and the parents. After the study is complete, there will usually be routine follow-up visits and/or calls to help you withdraw from the medicine in a safe manner and to answer questions.
To learn more about clinical trials, visit our Frequently Asked Questions page.
Kennedy Krieger conducts clinical trials for numerous diseases and disorders. Visit our Current Clinical Trials page to find a list of ongoing trials. If you would like to find out more about participating in a clinical trial, email email@example.com.