Insider Insights

Germany: Pros and cons of register-based randomised trials, as defined by IQWiG. 

October 6, 2022

Study designs that combine explanatory and pragmatic aspects have recently been weighted up by authors at IQWiG with a particular focus on register-based randomised control trials. 

Randomised control trials are often required for the approval of new drugs and are often seen to be the gold standard for comparing new treatments to pre-existing ones. However, they often come under criticism as they can be too complex, too lengthy and the heavily controlled conditions may not be transferable to everyday clinical care. These disadvantages has caused pragmatic studies such are real world evidence studies to gain traction and are favoured by some randomised control trials critics. 

In an article in the journal Prevention and Health Promotion , Stefan Lange, deputy head of the Institute for Quality and Efficiency in Health Care (IQWiG ), and his colleague Jörg Lauterberg present the spectrum that lies between these two study designs. If a trial is overly pragmatic then the data can loose its meaning as there are not a sufficient amount of control parameters and so some differences may no longer be able to observed. However, they do facilitate the large number of patients that may be required for differences to become apparent.  

Register- based randomised control trials may facilitate the combining the best of both worlds. i.e. provide reliable knowledge that can be transferred to routine care and be less complex to carry out, since they use existing structures from patient registers. Lange and Lauterberg point out the potential of such a design but had concerns that the data quality of the basic variables and outcomes in many registries is not yet sufficient for good Register- based randomised control. 

In their article, Lange and Lauterberg propose a modification of the legislation in Germany of the application-accompanying data collection for medicinal products with very limited evidence. In it, randomised comparisons are currently excluded. However, in Lange and Lauterberg’s opinion, further research into such new active substances with relatively uncomplicated and but meaningful register – based RCTs should definitely be made possible. 


  1. Registerbasierte randomisierte Studien: das Beste aus beiden Welten? . Accessed 4th October 2022 
  2. Lange, S., Lauterberg, J. Pragmatischere randomisierte Studien mit Fokus auf Registerbasierung. Präv Gesundheitsf (2022). 

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