Global Partners.
International Collaboration
MICYRN’s international partnerships are helping to bring clinical trials for children to Canada. This work is also establishing international differences and similarities between the regulatory and ethics pathways for pediatric clinical trials, and ensures Canada is contributing to global solutions.
Pediatric Trials Network
In 2015, MICYRN was established as the national portal for the Pediatric Trials Network (PTN)—led out of Duke University—to facilitate a coordinated opening of Canadian sites.
MICYRN has presented at annual Enpr-EMA workshops—the only Canadian organization and, along with the Pediatric Trials Network (Duke University), one of only two non- European members on the Coordinating Group. Working groups made up of volunteers from Enpr-EMA members address public-private partnership, ethics, participation of young patients in research, GCP training, and trial preparedness. In addition, MICYRN chairs the working group on international collaboration.
Institute for Advanced Clinical Trials for Children
MICYRN and the Institute for Advanced Clinical Trials for Children (I-ACT) have united to bring industry-sponsored pediatric clinical trials to Canada.
MICYRN has collaborated with I-ACT since 2016, and most recently has been facilitating site identification and selection within the Network to determine potential investigators and connect with operational leads. I-ACT is leading the international working group that created a site qualification survey. The aim is to identify a common set of variables that sponsors of regulated international pediatric clinical trials require in order for a given site to be considered appropriate for participation. MICYRN is contributing to this rich survey by facilitating responses from Canadian industry sponsors The survey will be disseminated to industry representatives from all jurisdictions.
Click HERE to watch a presentation on the I-ACT Quality Improvement Program.
Enpr-EMA
MICYRN contributes to the development of a multi-national infrastructure to support global pediatric trials with European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)— a network of research networks, investigators and centres with recognised expertise in performing clinical studies in children.
MICYRN is an active participant on the Enpr-EMA Working Group on International Cooperation. The working group is comprised of regulator and network representation from Australia, Europe, the United Kingdom, Japan, United States, and Canada. The group conducted an environmental scan of each jurisdiction from both regulator and network perspectives on the clinical trial application submission and review process, and the ethics process from each jurisdiction.
Two manuscripts are under development to present the collected data. The first manuscript summarizes the clinical trial application for drugs, focusing on the current regulations and requirements for a CTA submission as well as proposed future regulations. The second manuscript discusses current ethics committee and independent review board requirements, as well as future harmonization initiatives.
conect4children
MICYRN and conect4children (c4c)—a large collaborative European network that aims to facilitate the development of new drugs and other therapies for the entire paediatric population—are working together to facilitate the development of new drugs and other therapies for the entire paediatric population.
