Ethics in R&D

Medicines for Children and Adolescents

“At Bayer, we take responsibility for young patients. Our commitment to this age group is reflected in our pediatric clinical trial programs.”
  • Dr. Stefanie Breitenstein, Pediatrician and Clinical Expert, Bayer

 

We all hope that our children will never suffer from a serious illness. But if we find ourselves in this position, we also hope that a suitable treatment is available. At Bayer, we are committed to researching and developing novel medicines specifically tailored to the needs of sick infants, children and adolescents.

Why it’s important to make medicines specifically for children

Medically speaking, children are not just “little adults”: a number of diseases only occur in children, or progress differently in children in comparison to adults. In addition, the composition of children’s bodies and the maturity of their organs differ from those of adults. Organs such as the lung, the liver and the kidneys are not yet fully developed in very young children and therefore the concentration of the medicine in the body and its effects might be different than in adults.

For this reason, the safety, effectiveness, and correct dose of a medicine must be determined for each affected age group. Pediatric medicines must also be developed in an application form suitable for children, such as mini-tablets, liquids or infusions.

How we design the development of medicines suitable for children

Everyone involved in pediatric clinical trials holds a special responsibility, both from a medical and an ethical standpoint. Minors who participate in clinical trials need extra protection and have to be actively involved in the decision about their participation. As in all clinical trials, strict regulations and ethical standards have to be applied in pediatric studies.

Pediatric expertise is required to assess the benefits, risks and burden of research with and for minors. At Bayer, we have set up a dedicated Pediatric Clinical Development Structure with pediatric specialists from various disciplines working together to ensure that the extensive specifications for such trials are met.

How to participate in a pediatric trial?

If you are looking for a pediatric trial, you will find our ongoing and completed clinical trials with children and adolescents (birth – 17 years) on www.clinicaltrials.gov.

Consent in pediatric research requires informed permission from the child’s legal guardian(s). In parallel, it is likewise mandatory to explain the process in an appropriate way to the pediatric patient so that the child understands what the trial is about and what it means being part of it and can agree to participate. The child will only be allowed to take part in the trial if all parties agree.