Dr. Martin Offringa’s program of research is captured under the Enhancing Research Impact in Child Health (EnRICH) program.
In 2019, health research is questioned by the public. Does it really advance health and improve health outcomes? Is it not wasted by design, conduct and reporting?
In response to these questions, new initiatives in partnership with patients, researchers, policymakers and other key stakeholders are underway. They aim to strengthen the research enterprise and improve the quality and usefulness of scientific studies in biomedicine and beyond.
Clinical research in children poses particular methodological, ethical and practical challenges. In the last 10 years, the paucity of safety and efficacy data informing the rational use of medicines has been recognized. New regulations have been implemented in the USA and in Europe which mandate proper clinical evaluations in children before any new drug can be labelled and licensed for adults.
To inform policy decisions researchers need to ensure their research is reliable and relevant to decision making. Current challenges include
- age specific drug dosages
- age specific drug formulations and administration
- adequate sample sizes
- relevant and justified comparators
- qualified, responsive, and child and family relevant 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 study design to reporting to implementation of results
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.
The work of the EnRICH Research Group and Network aims to enhance child health through the discovery and implementation of innovative methods that transform the way we design, conduct, and report child health clinical research. In addition, the EnRICH program offers training opportunities in this field.
In 2019 the primary research agenda for EnRICH focuses on two critical areas for paediatric research: (1) developing the methodology needed to select, measure and report valid, discriminative, and feasible outcomes child health research, and (2) innovative methodology and tools (Bayesian Decision Analysis, Value of Information) to inform the sample size for clinical efficacy studies and comparative effectiveness trials.
For an overview of current projects, click here.