Methods for the collection of routine practice data for new drugs

The Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to develop a scientific concept on the methods used for the generation and analysis of routine practice data in the context of so-called routine practice data collection. This becomes important whenever studies on drugs for rare diseases or drugs with special approval in which the new drug was compared with the therapeutic standard have not been carried out.

Due to legal requirements, routine practice data collections can currently only be conducted as non-randomized comparative studies. The rapid report addresses seven topics that are important for the conduct of such studies, such as the identification and selection of so-called confounders, the determination of the observation start, the collection of patient-reported outcomes or the handling of missing values. The rapid report describes the available scientific knowledge on these topics and draws conclusions for the necessary quality standards in the implementation of a routine practice data collection.

IQWiG asks for comments

Interested persons, institutions and (professional) societies can submit comments on IQWiG's preliminary report until 19 August 2025. On 16 September 2025, IQWiG will hold a scientific debate to clarify further questions from the written comments. The results of the hearing may lead to changes and/or supplements to the preliminary report.