Department of Medical Statistics, University Goettingen

Working Group Biometry and Data Management in Clinical Trials


Aiming to improve biometry and data management in clinical trials the working group Biometry and Data Management in Clinical Trials was formed.
The working group lies at the cross-section between the Department of Medial Statistics and the Clinical Trials Unit UMG and supervises clinical trials in all aspects of biometry and data management.

Range of services


    1. Assistance in filing the application

    Together with the Clinical Trials Unit UMG we support grant applications concerning biostatistical aspects particularly, this includes assistance with:

    • Choice of primary and secondary endpoints
    • Choice of a suitable study design
    • Calculation of sample size and power
    • Early involvement of data management aspects

    2. Data management and off-site monitoring

    Results of clinical trials have to be collected reliable and in high quality to be plausible. Our data management supports you with these requirements by:

    • Creation of web-based databases in secuTrial®
    • Support with choice of items and assistance in conception of questionnaires
    • Configuration, validation and versioning of electronic case report forms (eCRF) for data collection
    • User management and user support concerning eCRF
    • Support in pharmacovigilance, e.g. reporting of (suspected/unexpected) serious adverse events
    • Creation of data management specific documents like safety reports, e.g. for administration, ethics committee, data monitoring committee
    • Query management/off-site data checks for securing high quality data
    • Database lock at end of the trial

    3. Interim analyses and statistical evaluation of clinical trials

    Following data acquisition and database lock the statistical evaluation is performed with special attention to the testing of primary and secondary endpoints. Besides the statistical evaluation at the end of trials this includes also evaluations during the trial. The working group handles all necessary biometrical aspects concerning the evaluation of your trial data:

    • Creation of a statistical analysis plan (SAP)
    • Intermediate statistical analyses, e.g. sample size recalculations
    • Descriptive evaluation of patient population
    • Statistical evaluation of primary and secondary endpoints of different data types
    • Preparation of meaningful graphics

    4. Assistance with publications

    Subsequently to clinical trials the results are mostly published. Here we also offer:

    • Evaluation of specific statically questions
    • Explanation of used statistical methods ("Material and Methods")
    • Creation of publication-ready graphics
    • Publication of trial protocols

    Contact:


    Thomas Asendorf, M.Sc.
    Group Head
    WG Biostatistics & Data Management in Clinical Trials
    (Department of Medical Statistics | Clinical Trial Unit UMG)
    Von-Siebold-Straße 3
    37075 Göttingen
    Phone: 0551 / 39-63026
    E-Mail: thomas.asendorf@med.uni-goettingen.de