gms | German Medical Science

63. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e. V. (GMDS)

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie

02. - 06.09.2018, Osnabrück

Towards explorative trials for precision prevention

Meeting Abstract

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  • Georg Fuellen - Universitätsmedizin Rostock, Institut für Biostatistik und Informatik in Medizin und Alternsforschung, Rostock, Deutschland

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie. 63. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS). Osnabrück, 02.-06.09.2018. Düsseldorf: German Medical Science GMS Publishing House; 2018. DocAbstr. 208

doi: 10.3205/18gmds100, urn:nbn:de:0183-18gmds1003

Veröffentlicht: 27. August 2018

© 2018 Fuellen.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe



Introduction: Individualizing healthspan-promoting interventions is the precision medicine approach to healthy aging. Interventions in rhesus monkeys demonstrate that healthy aging can be promoted by diet intervention in animal models close to human. In the form of caloric restriction mimetics, feasible diet and small-molecule interventions are now on the horizon. These interventions must ultimately be combined in individualized ways. In turn, good biomarkers are needed, both for intervention selection and outcome assessment. Blood count data and omics data are examples for the former, while epigenetic clocks based on DNA methylation are gaining acceptance for the latter. Marker-based strategy designs are now used to guide precision medicine trials in oncology.

Methods: We conducted a literature survey.

Results: The specific problems posed by trials for individualized healthspan-promoting interventions will be described, regarding the biomarker-based choice of interventions, of endpoints (incl. surrogate biomarkers) and other variables to be measured, choice of trial participants and overall design. One consideration is whether the control group should be given standard-of-care, or a random choice of the interventions. Another consideration is how the individual assignment of interventions can be based on molecular biomarker(s) such as gene expression measurements, which are only informative in aggregate, affecting the power analysis. Also, informed consent of elderly people to biomarker-based trials may be an issue.

Discussion: Precision prevention trials are becoming feasible based on progress in effective interventions, biomarkers and trial designs. Feedback from the biometrics/biostatistics community is sought and highly appreciated.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.