As announced by two officers from the Food and Drug Administration (FDA), in a perspective published in the Clinical Journal of the American Society of Nephrology, real-world data quality issues are increasing.

Considering the growing interest supported by the improvement of technologies in this sector, the agency is currently investigating when the use of observational data “may be appropriate for evaluating effectiveness from a broad policy perspective and also how individual drug manufacturers submit proposals for using real world data to support marketing applications”, in the words of Aliza Thompson and Mary Ross Southworth of the Division of Cardiovascular and Renal Products within the FDA Center for Drug Evaluation and Research (CDER).

Even though it is recognized that real world data and real world evidence can make an effective contribution to accelerating the development of therapies, there is still much to be done, and the authors have explained that efforts will have to be made to define “how and when real world data and real world evidence can be used”.

In addition, it will be necessary to ensure data quality in order to make reliable decisions, and at the same time to understand which study designs and analytical approaches, using real world evidence, will guarantee a level of certainty and scientific rigor as close as possible to what is requested by regulatory standards.

While we are waiting for the FDA’s key considerations: ”There is also widespread recognition that there will be a learning curve, and that stakeholder engagement and demonstration projects will be critical”.