Children's Medicines Working Party
The EFGCP's Children’s Medicines Working Party (CMWP) promotes the highest scientific, ethical, safety, and quality standards for the design, conduct, and analysis of biomedical research and medicines development for children of all ages.
The CMWP is a Multi-Stakeholder Working Group with its scope of activities focusing on:
- Contributing to ethical, scientific, legal, safety and societal issues related to the design, conduct, analysis and reporting of biomedical research and development of new medicines for children of all ages. This includes addressing the specific needs of children for child appropriate formulations.
- Enhancing and maintaining effective cooperation with European and International organisations and relevant stakeholders (academic researchers, patient organisations, regulators, policy makers, pharmaceutical industry, learned societies, professional organisations and others) to facilitate the development of medicines to improve children’s health using the highest practical and ethical standards at the European and global level.
The main objectives of the CMWP relate to supporting the development of safe and effective medicines for children by:
- Providing a communication platform for members to identify issues, share best practices and latest information related to paediatric medicines and clinical trial designs in a global context
- Contributing ethically and scientifically to sound development processes and research practices in order to increase children’s access to effective and safe medicines
- Contributing to continuous training on paediatric medicines for experts in collaboration with European organisations (e.g. European Medicines Agency, Drug Information Association)
- Facilitating the discussion in Europe towards a broader public agreement on the needs for better medicines for children.
Working Party Projects
The European Forum for Good Clinical Practice (EFGCP) Children’s Medicines Working Party (CMWP) has identified a need within the research community for a tool to support decision-making on the appropriateness of adolescent inclusion in adult trials.
The team has developed an open-access ‘Adolescent Inclusion Decision Tree’ for use by trial sponsors, trial investigators, IRBs/ethics committees, and health regulatory agencies, when a trial with age-inclusive trial design is being explored, developed or reviewed. The tool outlines over-arching principles for consideration, and guides users through 5 categories to ascertain the appropriateness of the clinical trial for adolescent inclusion: (1) disease, (2) product, (3) statistical, (4) operational, and (5) legal & ethical.
This tool is not designed to establish a minimum “cumulative score” which must be met to allow adolescent inclusion in an adult trial. This tool is intended to provide a general framework upon which trial sponsors, investigators, health agencies, and/or ethics committees can systematically and reliably evaluate areas of potential conflict within the development of the trial protocol and engage in robust conversation on the appropriateness of adolescent inclusion in relevant adult trials.
This tool is intended to be updated periodically. The CMWP welcomes hearing about your experiences using the tool and will be more formally seeking suggestions for improvement in the near future.