The European Medicines Agency (EMA) on Monday released recommendations from its European network of pediatric research (Enpr)-EMA working group on opportunities during various stages of development to consult with pediatric research groups.
“Enpr-EMA suggests that all companies consider using these opportunities in a spirit of shared learning about the best way to collaborate during [pediatric investigation plan] planning,” EMA writes, noting that companies can benefit from the scientific and logistical expertise available within the network.
Specifically, EMA says drugmakers should consider consulting with pediatric research networks at four different points during the drug development lifecycle, “from scientific idea to clinical studies of the PIPs and safety follow-up after marketing authorization.”
According to the document, the four stages are:
- Scoping and Exploring
- Doability and Targeting
- Feasibility and Implementing
- Reporting and Safety Follow-Up
During the scoping and exploring stage, EMA says that consultations can help drugmakers address issues from identifying areas of unmet pediatric need, designing a global clinical development plan or understanding aspects of the natural history or standard of care for a pediatric condition.
EMA says it especially recommends drugmakers consult with a pediatric research network at this stage when developing products to treat rare diseases.
At the doability and targeting stage, EMA says that drugmakers can consult on more specific issues that could factor into the development of a PIP, such as inclusion criteria for pediatric studies, whether the formulation and dosing are appropriate for the target population and ethical considerations.
“This is the most suitable initial option before PIP submission (in order to avoid several amendments rounds and a delayed PIP process) for all diseases and conditions,” EMA writes.
At the feasibility and implementing stage, which occurs after a PIP is agreed on, EMA says sponsors should consider a pediatric network consultation “in order to implement latest changes in the clinical practice and in the occurrence of competing trials.”
Drugmakers can also use the consultation to discuss and confirm details such as the availability and number of possible trial subjects in different countries, the relevance of the study protocol compared to standard practice and other issues relevant to the PIP.
Once a PIP has been implemented, EMA says that sponsors may wish to have a final consultation to discuss issues related to trial documentation and safety follow-up.