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Table 2 ERA-NET PRIOMEDCHILD recommendations for framework conditions facilitating medicines for children research

From: Framework conditions facilitating paediatric clinical research

Identified Issues ERA-NET PRIOMEDCHILD recommendations
Decision-making process Open the governance to a collective involvement of all stakeholders including a more active involvement of parents' associations and viewpoints of children as soon as the protocol elaboration begins.
Ethics Committees' expertise Develop criteria for accreditation of paediatric ethics committees in EU countries and identify in EU-member-states the qualified ethics committees to review paediatric research.
Education & Training in clinical pharmacology Promote education and training in paediatric research with formal EU academic recognition. Train a team of experts in paediatric research independently remunerated for the review of study protocols. Implement dedicated units with qualified and trained people in paediatric clinical research within public hospitals, scientific societies, regulatory authorities and ethics committees.
Multinational regulatory approvals Create the function of independent ethics coordinator to facilitate communication between local/national local ethics committee for multicentre/international clinical trials.
Time to come to the decision of consent Establish guidelines i) to allow sufficient time to consider pros and cons for child participation into a clinical trial including the possibility to ask for external advice ii) to give the opportunity to parents and children to debate on ethical issues in dedicated places with trusty persons before and during child's involvement in clinical trials.
Integrated safety data- base Systematic collection, monitoring and analysis of clinical trials data with medicines provided by sponsors and periodic publishing of the reports being accessible to professionals and to the general public.
Sharing strategies and plans Harmonize the interaction between EMA and FDA in order to agree on paediatric development programmes or waivers to avoid exposing children to unnecessary trials.
Adapted methodologies & design Implement urgently methodologies and strategies using the lowest possible number of subjects as outlined in the EMA guidelines on clinical trials in small populations.
Unmet need for children Reduce the prevalence of unmet need for children research by i) amending the regulation to compel the development of new indications and formulations for off patent products, ii) supporting adequate public-private partnership for off label drugs research, iii) developing specific procedures or guidelines adapted to non-profit research.
IPR issues Establish a EU legal framework for the Intellectual Property Right (IPR) issues arising from private-public partnership in paediatric clinical research