24 January 2020 - Rapid report shows how routine practice data should be collected and processed.
Particularly in the case of accelerated drug approvals and drugs for rare diseases (orphan drugs), the evidence available at the time of market access is often insufficient for the early benefit assessment of drugs. Often, the studies are too short or no data on patient-relevant outcomes were collected.
Comparisons with the German standard of care are also often lacking. In order to close such evidence gaps, in future, routine practice data are also to be included in early benefit assessments of drugs.