NANA – Registry-based non-randomized studies for assessing the benefits and harms of drugs

Department of Medical Statistics

Overview

The research team in the NANA project is investigating whether it is currently possible and sensible to use the registry data available in Germany for assessing the benefits and harms of new drugs. 

For this purpose, the team is carrying out ten to twelve register-based non-randomized studies. The results of these analyses will be compared with the existing results on the same clinical question from randomised controlled trials.

The project aims to provide insights into the circumstances under which an analysis based on routinely collected data can provide reliable results on the benefits and harms of drugs and which aspects need to be carefully considered when such analyses are implemented.

The project is funded by the “Federal Joint Committee”. Find here the project description of the “Innovationsausschuss”.

Project process

Starting point of each emulation was a clinically relevant question formulated under the PICO framework and identified to equal parts through one of two possible processes. Our advisory board consisting of pharmacological experts compiled a list of currently relevant questions for which we tried to identify and recruit suitable registers
In addition, we contacted potentially suitable German registers and recruited those that were interested and offered to provide suitable data. Questions were then formulated by clinical experts chosen by cooperating registers. 

The basic PICOS are translated to more detailed target trials through iterative discussions with the clinical experts. If an emulation is feasible in principle using the available data, we create a study protocol and conduct a prospective risk of bias assessment

While we conducteach non-randomized registry-based cohort study, we record all feasibility problems and relevant methodological aspects. 

This is followed by a final bias assessment and a systematic comparison of randomized controlled trials (RCTs) on the same clinical question (if available) and our results in order to assess causes of deviation between the two.

Besides gaining insights on the feasibility of conducting such non-randomized studies using currently available German registry data we also aim to support the dissemination of state-of-the art statistical methodology. 
We develop materials like templates for all important steps of the analysis process and reusable R analysis scripts that will be made available to the public.

Given talks and presentations

As part of the NANA project, the following presentations and talks were given:

Contact

Leitung

Univ.-Prof. Dr. Tim Friede

Univ.-Prof. Dr. Tim Friede

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Wissenschaftlicher Mitarbeiter

Omar Ammous, M.D.

 Omar Ammous, M.D.

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Datenmanager

Enes Malik Cakir, MSc

 Enes Malik Cakir, MSc

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Wissenschaftliche Mitarbeiterin

Dr. Regina Kampo

Dr. Regina Kampo

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Wissenschaftliche Mitarbeiterin

Susanna Salem, MSc

 Susanna Salem, MSc

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Doktorandin

Maxi Schulz, MSc

 Maxi Schulz, MSc

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Wissenschaftliche Mitarbeiterin

Paula Starke, MSc

 Paula Starke, MSc

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