Real world data

The enormous progress that has been made in digitalisation has opened up access to medical data which, in contrast to data from conventional clinical trials, are generated in the patient’s everyday setting. This is known as real world data (RWD).

RWD have a wide range of uses, from assessing the safety and efficacy of therapies and risk-benefit assessments for certain diseases, to complex diagnoses and conclusions about patterns and striking features in specific patient groups.

The recruitment and participation of patients in clinical trials can also be facilitated by RWD. Hospitals can select suitable participants faster and better using their own patient data. Smartphone apps and wearables help patients to record and transmit their health data wherever they are, thus reducing the number of hospital visits.

Creating fair conditions

The use of RWD in research can only be beneficial, however, if the data are of high quality, obtained under defined conditions and evaluated carefully. Here, there is a need to create a framework that ensures fair compensation for the major effort involved in generating and curating this kind of data and for the innovations that RWD make possible. Data intended to promote health should be widely available. At the same time, compliance with data protection regulations must be ensured. The effort involved in generating, curating and making the data available must be rewarded and the necessary awareness of the different types of RWD must be created. On the one hand, there are RWD that are obtained almost as a by-product under uncontrolled conditions, and on the other, there are RWD that need to fulfil very high quality requirements. RWD obtained specifically for clinical authorisations should be accorded protection similar to that given to conventional clinical data.