About the EnRICH Research Group and Network
Dr. Martin Offringa’s program of research is captured under the Enhancing Research Impact in Child Health (EnRICH) program.
Clinical research in children poses particular methodological, ethical and practical challenges. Recently the paucity of safety and efficacy data informing the rational use of medicines has been recognized with new regulations in the USA and in Europe which mandate proper clinical evaluations in children before a new drug can be labelled and licensed for adults To inform policy decisions researchers need to ensure their research is reliable and relevant. And so, while more research is needed, we need to embrace new conceptual and methodological advances in the design, conduct and reporting of child health research. Current challenges include age specific dosages, age specific formulations and administration, adequate sample sizes, relevant and justified comparators, qualified, relevant and standardized outcomes, contained risk of bias, short term and long term participants’ safety, clear roles of data monitoring committees, harmonized ethics review of research protocols, appropriate engagement of children and families from design to implementation of research.
In 2019, health research is questioned by the public, asking whether it really advances health and improves health outcomes, whether it is not wasted by design, conduct and reporting, and in fact does not inform policy decisions. New initiatives in partnership with patients, researchers, policymakers and other key stakeholders like the REWARD Alliance Meta-Research Innovation Center at Stanford METRICS aim to strengthening the research enterprise and improve the quality and impact of scientific studies in biomedicine and beyond.
The work of the EnRICH Research Group and Network aims to enhance child health through the discovery of innovative methods that will transform the way we design, conduct, and report child health clinical research. In order to provide global solutions to methodological problems in paediatrics, EnRICH is engaged in a number of local and international initiatives including:
- Instrument for reporting of Planned Endpoints in CTs (InsPECT 2019)
- SPOR Innovative Pediatric Clinical Trials Project (IPCT)
- Toronto Outcomes Research in Child Health (TORCH 2019) and the Core Outcome Measures in Effectiveness Trials Initiative (COMET)
- Young Persons Advisory Group Start-up Tool (YPAG)
- Preferred Reporting Items for Systematic reviews and Meta-Analysis – Reporting for Children (PRISMA-PC 2019)
- Consolidated Standards of Reporting Trials –Children (CONSORT-C 2019)
- Standard Protocol Items for Randomized Trials – Children (SPIRIT-C 2019)
- Standards for Research in Child Health (StaR Child Health 2019)
In addition to these initiatives the EnRICH program offers training opportunities in the form of a course on Innovative Trial Design and postdoctoral fellowships in clinical research methodology.
In 2019 the research agenda for EnRICH focuses on two critical paediatric research areas: (1) develop and apply innovative methods needed to select, measure and report valid, discriminative, and feasible outcomes in child health research, and (2) develop and apply innovative methods and tools to inform the design of (adaptive) clinical efficacy studies and comparative effectiveness trials.
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Updated January 2019