Current Edition

The Essentials of the Informed Consent and Assent Process in Paediatric Clinical Trials

Alex Cvetkovic Muntañola, MD, Executive Director Clinical Development at INC Research, illustrates how everybody involved in paediatric drug development is aware of the complexity and sensitivity of the consent process in clinical trials involving the paediatric population. The specifics are due to the vulnerability of this population and the fact that somebody else (subject’s parents or legal representative) has legal rights to make decisions on a child’s behalf.