Authors include representatives from PAHO/WHO, Critical Path Institute, FDA (CBER and CDER), EMA, NIH, IMI, ACRO, CDISC, Lilly (TransCelerate), Sanofi (DataSphere), Pfizer, and Elligo Health Research.
Clinical research is vital for improving health around the world, yet its complexities are immense. The use of data standards are key to ensuring interoperable, comprehensible and reusable data, and yet the practice of research data standardization is often neglected. This neglect contributes significantly to irreproducible research; limiting the sharing or secondary use of data; delaying and obstructing the development of evidence reviews to support decision-making by physicians, regulators and policy makers; and ultimately eroding the public’s trust in the research enterprise. Mature clinical and translational research standards exist, as do tools that enable efficient analysis to encourage transparency and collaboration. Policy makers and funders have the opportunity to play a pivotal role in improving research through support or requirement of standards in regulated and unregulated research to enable the collection of the most robust evidence to inform healthcare decisions and future research.