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Mobile access to virtual randomization for investigator-initiated trials
Thomas M Deserno1, András P Keszei2
11 Peter L. Reichertz Institute for Medical Informatics (PLRI), University of Braunschweig and Medical School Hannover, Braunschweig, Germany.
Clinical Trials (London, England)
|April 29, 2017
Summary
Virtual randomization via smartphones offers an affordable and accessible solution for unbiased treatment allocation in clinical trials. This mobile system computes allocations on demand, enhancing trial integrity for investigator-initiated studies.
Area of Science:
- Clinical Trials Methodology
- Health Informatics
- Biostatistics
Background:
- Randomization is crucial for unbiased clinical trial treatment allocation and statistical validity.
- Centralized randomization systems can be costly and inaccessible for certain trials.
- Investigator-initiated trials often lack resources for sophisticated randomization methods.
Purpose of the Study:
- To introduce a mobile-accessible virtual randomization system for clinical trials.
- To provide an affordable and on-demand allocation method for investigator-initiated studies.
- To ensure unbiased treatment allocation and valid statistical inference in resource-limited settings.
Main Methods:
- Developed a system integrating electronic data capture/clinical trial management systems with an R interface via Java R Interface.
- Utilized representational state transfer web services for mobile device communication.
- Implemented a comprehensive R script supporting various randomization models (simple, block, stratified) for blinded and unblinded trials.
Main Results:
- Developed iOS and Android applications for smartphone-based randomization.
- Successfully randomized 156 subjects across five investigator-initiated trials using mobile devices.
- Instantaneous display and storage of allocation numbers and treatment arms.
Conclusions:
- Virtual randomization transforms traditional allocation lists into on-demand computations, ensuring trial integrity.
- This mobile solution makes advanced randomization accessible for investigator-initiated and potentially large multi-center trials.
- The system supports 88% of common randomization models, enhancing broad applicability.
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