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 2017, 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 Meta-Research Innovation Center at Stanford METRICS aim to strengthening the research enterprise and improve the quality of scientific studies in biomedicine and beyond.