WP9: Statistics and data management
Work package 9 is led by Prof. Dr. A. Dempfle (IMIS) and MSc K. Brandt (ZKS), who both have extensive experience in the planning and conduct of clinical trials in various fields of medical research.
The aim of the work package 9 "Statistics and data management" is to ensure best methodologic quality of the randomized sham-controlled phase I and IIa clinical studies and proper management of acquired data. Continuously, the progress of data acquisition will be monitored. High-quality data will be analysed with advanced statistical methods.
The main objectives of work package 9 are:
- To provide statistical expertise to ensure the highest possible quality of results
- To provide monitoring for the clinical studies
- To provide data management for the clinical studies
- To provide statistical support to any of the applicant partners
- To assure data security
Main tasks of work package 9 are:
- Preparation of clinical trials
IMIS and ZKS will contribute to the development of detailed study protocols. These protocols will follow all relevant guidelines, especially ethical aspects. Data documentation concepts will be developed and trained.
- Randomization, data management and electronic data capture
Randomization for all five randomized trials will be performed as detailed in the study protocol. Electronic Case Report Forms (eCRFs) for electronic data capture will be designed to collect all relevant baseline, treatment and follow-up data. A clinical trial database will be set-up.
- Measures to assure data security
All data collected will be managed in a safe and secure environment. Data transmissions will be encrypted with secure socket layer (SSL) technology. The database server with the stored data is located in a secure data centre and is protected by a firewall. Only trained and authorized investigators and site-staff are allowed to enter or edit data. Backups are performed regularly.
To assure high-quality data and patient safety a quality control system will be established. There will be regular on-site monitoring visits and monitoring reports will be generated that cover all quality aspects of the study conduct, data documentation as well as patient safety and recruitment. ZKS Kiel will coordinate the overall monitoring process.
- Development of statistical analysis plan and statistical analysis
A detailed statistical analysis plan will be developed for each trial and all statistical analyses performed. The statistical analyses will cover all clinical studies with respect to primary and secondary outcomes. The interpretation and publication of the study results will be done in collaboration with the other partners.
- Provide statistical support
IMIS will provide statistical support to the partners of the STIPED Consortium if needed. Statistical modelling for a proper analysis of neurophysiological and neuroimaging data will be done using appropriate statistical methods.