Article
A survey on the quality of biostatistical aspects in studies evaluated by medical ethics committees
Search Medline for
Authors
-
Geraldine Rauch
- Institute of Biometry and Clinical Epidemiologie, Charité Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany
-
Lorena Hafermann
- Institute of Biometry and Clinical Epidemiologie, Charité Universitätsmedizin Berlin, Berlin, Germany
-
Iris Pigeot
- Leibniz Institute for Prevention Research and Epidemiology (BIPS), University of Bremen, Bremen, Germany
-
Ulrich Mansmann
- Universität München, München, Germany
| Published: | September 6, 2019 |
|---|
Outline
Text
Background: The global aim of medical ethics committees is to judge the scientific quality and validity of medical research projects (studies), thereby assessing the benefit-risk profile. Apart from judging content-related aspects and the legal validity, the study design and the analysis strategy must also be assessed from a biostatistical point of view. According to the latest amendment of the "Arzneimittelgesetz" (AMG), a biostatistician is a mandatory member of medical ethics committees. The level and quality of the biostatistical aspects within medical studies presented to medical ethics committees varies widely. The biostatistical requirements for a medical research project are however not standardized and there exist no national guidelines or recommendations.
Objectives: The aim of this work is to systematically assess the current state of the art with respect to the level and quality of biostatistical aspects within medical studies presented to medical ethics committees. From a systematic assessment of common pitfalls, misspecifications and incomplete biostatistical aspects within medical studies, we hope to get a basis for the important task of guideline development.
Materials und methods: We conducted a systematic survey on biostatisticians who are or were active as members of medical ethics committees in Germany. The survey consisted of 11 items addressing the quality of medical studies presented to ethics committees with respect to a number of biostatistical topics.
Results and conclusions: From 103 biostatisticians which we actively contacted via email, 58 (56.3%) participated in our survey. The participants came from nearly all states in Germany. A total of 45 (91.8%) participants indicated that studies according to the AMG have a higher biostatistical level than freely formulated studies. Participants judged a median to high need for quality improvement for all biostatistical topics including sample size calculation, multiple testing, missing values etc. The presentation will present the detailed results and conclusions.
The authors declare that they have no competing interests.
The authors declare that a positive ethics committee vote has been obtained.
