A visit to our unit
When you visit the Clinical Trial Unit for Paediatrics and Adolescent Medicine, you will be welcomed by a dedicated team of physicians, research nurses, and a dietitian, all of whom have extensive experience in conducting clinical drug trials involving children and adolescents. We are committed to providing a safe and supportive environment for both patients and their families, and we take the time to answer any questions you may have along the way.
A visit to the unit may include consultations with our staff, clinical examinations, sample collection, or follow-up assessments as part of a clinical trial. The specific activities at each visit will depend on the study in which you are participating.
We place great importance on ensuring that children, adolescents, and their families feel well informed, supported, and comfortable throughout their participation.
Throughout the study, you will have a designated point of contact who will help coordinate visits and answer any questions, ensuring that you always know who to contact if you need assistance.
Learn more about our unit and meet our team
What is a Clinical Drug Trial?
A clinical drug trial is a research study that investigates a new treatment or medicine that has not yet been approved for use or has not yet been approved for a specific disease or patient population. The purpose is to generate new knowledge about the safety and effectiveness of treatments and thereby help develop new therapeutic options that can benefit patients in the future.
At the Clinical Trial Unit for Paediatrics and Adolescent Medicine, we conduct clinical drug trials across a range of disease areas affecting children and adolescents. Through our research, we provide children and adolescents who have limited or no existing treatment options the opportunity to access new and promising therapies. At the same time, we contribute to the knowledge needed to develop future treatments for the benefit of children and adolescents in Denmark and around the world.
Before a clinical drug trial can begin, a number of requirements must be met to ensure both the quality of the research and the safety of participants. These include:
- The trial must be approved by both the Danish Medicines Agency and the Medical Research Ethics Committees.
- The trial must be conducted by qualified personnel with the necessary education, training, and experience.
- The trial site must have the required facilities, equipment, and access to relevant examinations, laboratory tests, and imaging procedures.
- The trial must follow a detailed study protocol that precisely describes how the study will be conducted.
- The trial must be conducted in accordance with the international quality standard known as Good Clinical Practice (GCP), which is designed to ensure both the quality of the research and the safety and rights of participants.
What happens if I participate?
If you are invited to take part in a clinical drug trial, you and your family will first receive comprehensive information about the study. You will have the opportunity to ask questions and will be given time to consider your decision before deciding whether participation is the right choice for you. There is always a legally required reflection period, allowing you to make an informed decision based on a full understanding of the study.
If you decide to participate, informed consent will be obtained, and an assessment will be carried out to determine whether you meet the study's eligibility criteria. If you are eligible, your participation will be planned and conducted according to the study protocol.
Every study is different, and therefore the duration, number of visits, and procedures involved may vary. Before the study begins, you and your family will receive detailed information about what participation involves, so that you know what to expect throughout the study journey.
Your rights as a participant
Participation in a clinical drug trial is always voluntary. Before you or your child decides whether to take part, you will receive comprehensive verbal and written information about the trial, enabling you to make an informed decision.
As a participant, you have the right to:
- Receive information about the purpose, procedures, benefits, and potential risks of the trial.
- Ask questions and be given sufficient time to make your decision.
- Withdraw your consent at any time without any consequences.
Read more about clinical trials on the Danish Medicines Agency's website
Read more about your rights as a research participant on videnskabsetik.dk