Similarly to older adults, children are a unique population with different physiological and developmental needs than adults. Children are effected by diseases and medicines in unique ways, which in turn means that the effectiveness of specific drugs should be measured independently.
It is important to perform clinical trials in children because scientists need to determine how different treatments, medications, and devices work on these populations.
Clinical research studies in children are what have helped develop child-appropriate medications and figure out which doses are the safest for each age group.
Sometimes when a child is suffering from a medical condition the doctor might ask the parents to consider enrolling him or her in a clinical trial to become part of a group of patients that are testing of a new drug or treatment.
What is a Clinical Trial?
Clinical trials are a type of research study designed to test the effectiveness of a new drug or treatment. Clinical trials are meticulously designed, planned, and carried out by scientists and other experts. These trials are carefully monitored by internal and external agencies in order to maintain the highest standards possible and to ensure the safety and comfort of its participants. Before a clinical trial even begins, it needs to be approved by the FDA and by an Internal Review Board that makes sure no part of the study poses a more than minimal risk for its participants and that the proposed research is clinically necessary and relevant.
External Link: For Parents and Children
All research studies are completely voluntary, meaning that the choice of participating in a clinical trial is completely up to the individual or legal guardian of the individual. This also means that any person has the right and freedom to withdraw their consent at any point in time. Withdrawing consent during the research study will not yield any physical or monetary consequences, nor will it affect their ability to receive adequate medical care.
If a parent agrees to enroll their child in a research study they must sign an informed consent document, which will outline all relevant information about the study as well as all the potential risks and benefits this trial might pose to the participant.
It is important to note that by the time a drug has reached advanced stages of the clinical research, it has generally been extensively tested on animals and sometimes even on healthy individuals to assess its potential toxicity, bioavailability, and general safety.
- PACT Programme for Parents of Children With SHCN
on May 13, 2026 at 4:00 amConditions: Urologic Diseases; Gastrointestinal Diseases; Vascular Diseases; Cleft Lip and Palate; Neurodevelopmental Disorders; Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorder; Developmental Delay Interventions: Behavioral: Prosocial-orientated Acceptance and Commitment Training plus positive parenting advice; Behavioral: Positive parenting advice Sponsors: Chinese University of Hong Kong; Hong Kong Children's Hospital; Hong Kong Young Women's Christian Association Recruiting
- The Effect of Mobile Devices on the Development and Health of Young Childrenon December 19, 2025 at 5:00 am
Conditions: Development and Health; Behavior and Behavior Mechanisms; Cognition; Physical Health; Parent-Child Relations; Education; Technology Use Sponsors: Sheffield Hallam University; University of Huddersfield; University of Leeds; University of Strathclyde; Edge Hill University; University of Wollongong; Teesside University Recruiting
- Loving Habits: A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habitson December 19, 2025 at 5:00 am
Conditions: ADHD Interventions: Behavioral: Behavioral Parent Training Sponsors: Okinawa Institute of Science and Technology Graduate University Recruiting
- Acceptability and Feasibility of a Single-Session Online Parent-Focused Intervention Targeting Child Body Image Developmenton December 18, 2025 at 5:00 am
Conditions: Eating Disorders; Body Image Disturbance; Weight Bias Interventions: Behavioral: Child Body Image Development Workshop Sponsors: University at Albany Recruiting
- A Trial to Improve Family Clinical Note Access and Outcomes for Hospitalized Childrenon December 18, 2025 at 5:00 am
Conditions: Hospitalized Child; Pediatric Patient Safety; Medical Errors; Parental Engagement in Care; Inpatient Pediatric Care Interventions: Other: Access to medical notes Sponsors: University of Wisconsin, Madison; Agency for Healthcare Research and Quality (AHRQ); Pediatric Research in Inpatient Settings (PRIS) Network Recruiting
- Potential Benefits of Parent Child Interaction Therapy (PCIT)on December 17, 2025 at 5:00 am
Conditions: Autonomic Dysregulation; Anxiety; Depression; Parent-Child Relations Interventions: Behavioral: Parent-Child Interaction Therapy (PCIT) Sponsors: University of Florida Recruiting
- Emotion and Symptom-Focused Engagement (EASE) for Caregiverson December 17, 2025 at 5:00 am
Conditions: Trauma and Stressor Related Disorders; Pediatric Cancer; Caregiver Burden Interventions: Behavioral: Emotion and Symptom-Focused Engagement (EASE) Sponsors: University Health Network, Toronto; The Hospital for Sick Children; Canadian Institutes of Health Research (CIHR) Recruiting
- Investigating the Efficacy of a Paediatric Fertility Preservation Decision Aid in Parents and Adolescents and Young Adults (CAYA) Cancer Survivorson December 16, 2025 at 5:00 am
Conditions: Unmet Fertility Information Needs Interventions: Other: Decision-aid Sponsors: Murdoch Childrens Research Institute; University of Melbourne Recruiting
- Recognizing Children's Needs: Impact on Early Childhood Regulatory Problemson December 15, 2025 at 5:00 am
Conditions: Regulation, Self; Reflective Functioning; Mentalization; Child Sleep; Parent-Child Relation; Crying; Feeding Problems Sponsors: Marmara University Recruiting
- A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolerson December 11, 2025 at 5:00 am
Conditions: Healthy; 24-Hour Movement Guidelines; Feasibility Studies; Sleep; Physical Activity; Screen Time; Sedentary Behaviors; Motor Skills; Cognition; Parent-Child Relations; Mobile Application; Health Education; Child Development Interventions: Behavioral: Shining Star mHealth App Sponsors: University of Kansas Medical Center; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Recruiting
- Parent Encouragement And Coaching of Happiness in Youthon December 5, 2025 at 5:00 am
Conditions: Depression; Parent-Child Relations Interventions: Behavioral: Parent Coaching; Behavioral: Active Control Sponsors: University of Pittsburgh; National Institute of Mental Health (NIMH) Recruiting
- Impact of Preterm Birth on Symptoms of Anxiety and Depression in Parents, and on the Precursors of Cognition, Including Social Cognition in Their Childon December 2, 2025 at 5:00 am
Conditions: Parental Anxiety Following Premature Birth Interventions: Behavioral: State-Trait Anxiety Inventory - Y ou STAI-Y Sponsors: CHU de Reims Recruiting
What Happens During a Clinical Trial?
All clinical trials are different and they depend on what the researchers are investigating. Most clinical trials are carried out in a hospital setting and all of them are performed under strict supervision.
One of the most common designs for a research study is called a randomized controlled trial (RCT). During an RCT the child will be randomly assigned into a treatment group or a placebo group, and participants will not know which group they were assigned to until the end of the study. This type of study is only carried out when participants are healthy enough to withstand a short amount of time without treatment. Regardless of the group they were assigned to, all participants will receive the necessary medical treatment after the study ends.
External Link: Is a Clinical Trial Right for Your Child?
What Are the Benefits of Enrolling My Child in a Clinical Trial?
Children clinical trials are very important to determine the safety and effectiveness of different medications and treatments for kids. Without clinical trials, doctors can only guess what is the appropriate dose for a child, so research studies are extremely important for taking the guesswork out of the clinical practice.
External Link: Why PTN Research Matters and Patient Safeguards in PTN Research
Scientist and pharmaceutical companies only carry out a research study when they have sufficient scientific knowledge to believe that a medication might actually be beneficial, so although it is never a guarantee, it is possible that the child has the opportunity to receive a potentially beneficial treatment even before it’s widely available.
What Are the Risks of Enrolling My Child in a Clinical Trial?
It is important to remember that a clinical trial is, after all, a trial; so parents should be prepared for the possibility of the treatment not working at all. Another potential risk is side effects; when a medication is being tested it is possible for some side effects to come up that were not present in previous phases of the study. To ensure that participants are safe, doctors and investigators monitor the effects of the treatment very closely by performing constant tests and assessments.