Work package 6: Statistics and Data Management
Description of the work package
This work package is led by Dr Florian Lagler of PMU with the assistance of Dr Angelika Moder for statistical analyses and document preparation.
This work to be done as part of this work package includes the preparation of study protocols including the statistical analysis plan and corresponding case report forms for trials to be performed in work package 8, work package 9, and work package 10. All clinical data will be collected, evaluated and reported. This requires a validated database system in compliance with the ICH E9 guideline and other regulatory requirements.
This system will be used for handling data cleaning processes and for final storage of the data. The statistical evaluation and presentation of the data will follow the standards of the ICH E3 and E9 guidelines. Results derived from statistical analyses within a trial will permit sample size calculation for the subsequent trials and will be the subject of final reporting.
The tasks included in this work package are described below:
- Preparation of documents for trials that are part of work packages 7 through work packages 10: Statistical analysis plans will be created as integral parts of the study protocols and corresponding case report forms (CRFs) firstly for trials in work package 8 and work package 9 after receipt of the final report containing results of work package 7 provided by KU Leuven and secondly for trial that is part of work package 10 after finalization of statistical evaluations of the respective previous trials.
- Calculation of sample size for trials of work packages 7 through work packages 10: The number of trial participants for each of the four trials will be calculated based on information derived from recently published results and data acquired over the course of the whole project.
- Data management for trials of work packages 7 through work packages 10: This task is designed to ensure the quality of the data collected in the clinical trials to facilitate optimal analysis and reporting of the clinical trials. This requires the following steps
a. Preparation of a SOP for data entry in the CRFs,
b. Implementation of a database and subsequent entry of CRF data,
c. Planning and execution of data validation steps.
- Statistical analysis of data derived from trials of work packages 8 through work packages 10: Statistical analysis is critical for answering the research questions and testing the hypotheses of each of the clinical trials mentioned above. Interim analyses of safety and efficacy data will be done according to the ICH guidance E9, ‘Statistical Principles for Clinical Trials’. For the study with healthy adult volunteers, our clinical partner KU Leuven will actively contribute to data analysis.
- Statistical reporting: This task is designed to help us set the stage for the publication of interim and final reports on the efficacy and safety of enalapril based on the data obtained in the clinical trials. Reports will be provided periodically to the scientific management to guide the planning and conduct of on-going and subsequent trials and the final publication of the trial outcomes.