Both US and EU paediatric regulations can be a strong incentive to generate the data patients, clinicians, and the society need, that is, more data on the effective and safe use of drugs in children. However, to ensure a successful impact of these regulations, numerous challenges have to be considered including the specific challenges related to recruitment in paediatric clinical studies. A stakeholder approach might be an appropriate way to understand the current position of all the relevant contributors needed to turn paediatric regulations into a useful tool. Caregivers started to develop clinical research networks and specific clinical research skills in addition to their clinical care. Knowledge of parental perceived barriers and incentives is of relevance to facilitate recruitment and retention, while the child neither is ‘an innocent bystander’ of a trial based on the concept of ‘assent’. In paediatric research, the trial design probably affects recruitment to a greater extent compared with adult studies. In general, if a study is designed well, with a clear clinical question with which parents/children can identify, they are likely to consider participation. Just like children are not small adults, paediatric studies are not just subgroup-adult studies. Active, open communication with all stakeholders involved will most likely result in the initial idea that drove the EU regulation, that is, ethically correct, practically feasible, scientifically sound, and economic reasonable studies are the most effective way to provide the children with the appropriated drugs and treatment they need.
|Title of host publication||Woodhead Publishing Series in Biomedicine|
|Place of Publication||Boston|
|Number of pages||8|
|Publication status||Published - 2020|