Articles

Advances in web-centric cloud computing have facilitated the establishment of an integrated cloud environment connecting a wide variety of clinical trial stakeholders. A web-centric cloud framework is proposed for real-time monitoring and risk prediction during clinical trials. The framework focuses on identifying relevant datasets, developing a data-management interface, and implementing machine-learning algorithms for data analysis. Detailed descriptions of the data-management interface and the machine-learning processes are provided, targeting active clinical trials with therapeutic uses in cancer. Demonstrations utilize publicly available clinical-trial data from the ClinicalTrials.gov repository. The real-time monitoring and risk prediction systems were assessed by developing five supervised-classification-machine-learning models for trial-status prediction and six unsupervised models for patient-safety-profile assessment, each representing a different phase of the clinical-trial process. All supervised models yielded high accuracy and area-under-the-curve values at the testing stage, while the unsupervised models demonstrated practical applicability. The results underscore the advantages of using the trial-status algorithm, the patient-safety-profile model, and the proposed framework for performing real-time monitoring and risk prediction of clinical trials.