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.
- GrowWell - Responsive Bottle Feedingon January 30, 2025 at 5:00 am
Conditions: Bottle Feeding Interventions: Behavioral: Digital Health Intervention; Behavioral: Safety Control Sponsors: Wake Forest University Health Sciences Recruiting
- Dyad Plus Effectivenesson January 30, 2025 at 5:00 am
Conditions: Weight Loss; Pediatric Obesity; Overweight Adolescents; Parent-Child Relations; Family and Household Interventions: Behavioral: Brenner FIT Standard; Behavioral: By Design Essentials; Behavioral: Dyad Plus Sponsors: Wake Forest University Health Sciences; National Institutes of Health (NIH) Recruiting
- Wellbeing and Resilience Among 1-3 Years Old Children of Mothers with Complex Mental Health Problems: a Pragmatic Clinical Trial of Online VIPP-SD Vs. Care As Usualon January 28, 2025 at 5:00 am
Conditions: Child Mental Health; Behavioral Symptoms; Child of Impaired Parents Interventions: Behavioral: Online VIPP-SD; Behavioral: Care As Usual Sponsors: University of Southern Denmark; Mental Health Services in the Region of Southern Denmark Recruiting
- Pai.ACT - An Artificial Intelligence Driven Chatbot Assisted ACTon January 23, 2025 at 5:00 am
Conditions: Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Neurodevelopmental Disorders; Intellectual Disability; Specific Learning Disorder; Communication Disorders; Motor Disorders Interventions: Behavioral: Pai.ACT Group; Other: Control Group Sponsors: Chinese University of Hong Kong; Hong Kong Christian Service; Hong Kong Young Women's Christian Association; Yang Memorial Methodist Social Service; Hong Kong Federation of Youth Groups; The Pamela Youde Nethersole Eastern Hospital Recruiting
- New Parent Support Program Evaluationon January 20, 2025 at 5:00 am
Conditions: Child Maltreatment Interventions: Behavioral: Take Root Home Visitation (TRHV); Behavioral: Services as Usual (SAU) Sponsors: Penn State University; United States Department of Agriculture (USDA) Recruiting
- Promoting Health Through Play Program: Improving Parent and Child Outcomeson January 17, 2025 at 5:00 am
Conditions: Child Development; Parenting Interventions: Behavioral: Playing Playfully to Overcome Adversity Sponsors: Yeshiva University; Head Start Recruiting
- Feasibility Study of a Behavioral Parent Intervention to Support Self-management in Pediatric Typ 1 Diabeteson January 16, 2025 at 5:00 am
Conditions: Type 1 Diabetes Mellitus; Parent-Child Relations; Self-management; Behavioral Intervention Interventions: Behavioral: Parent intervention Sponsors: Karolinska Institutet; Karolinska University Hospital Recruiting
- The Good Start Matters - Parenting Programon January 14, 2025 at 5:00 am
Conditions: Parenting Practices; Co-parenting Practices; Child Eating and Dietary Behaviors; Child Physical Activity/active Play/outdoor Play; Child Screen Time Interventions: Behavioral: Good Start Matters - Parenting intervention Sponsors: University of British Columbia; BC Children's Hospital Research Institute; Canadian Institutes of Health Research (CIHR); Michael Smith Foundation for Health Research Recruiting
- Efficacy of Parent-child Sleep Interventionon January 13, 2025 at 5:00 am
Conditions: Sleep Quality; Psychological Health; Infant Health Interventions: Behavioral: parent-child sleep intervention Sponsors: Taipei Veterans General Hospital, Taiwan Recruiting
- Parents' Experience of Child Loss During Pregnancy or Birthon January 13, 2025 at 5:00 am
Conditions: Stillbirth and Fetal Death; Miscarriages; Experience Interventions: Other: Workshops; Other: Focus group interviews; Other: Narrative interviews; Other: Delphi approach Sponsors: Fritz Sterr Recruiting
- The Effect of Two Different Cognitive-Behavioral Combined Programs in Blood Collectionon January 10, 2025 at 5:00 am
Conditions: Child Behavior; Pain, Acute; Fear Interventions: Other: control group Sponsors: Karamanoğlu Mehmetbey University Recruiting
- Using Social Robots in Children With Rare Diseases and Their Parents: A Feasibility Studyon January 9, 2025 at 5:00 am
Conditions: Rare Diseases Interventions: Behavioral: social robot intervention Sponsors: National Yang Ming Chiao Tung University 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.