Developing Customized Evaluation Software for Clinical Trials: An Example with Obstructive Lung Diseases

Abstract

Corresponding customized software tool is usually unavailable, which increases the time and workload for evaluating the results of a clinical trial. In the present paper, we demonstrate the development process of a customized software for one clinical trial on patients with obstructive lung disease. Over hundred patients and volunteers as controlled were in cluded in the clinical trial. They were examined by spirometry and EIT in a seated position during spontaneous tidal breathing. Subsequently, standard vital capacity maneuver and forced full expiration maneuver were performed. In or der to evaluate the offline data, a customized software was developed. The requirements of the software were defined by investigators. The software was then tested on patients’ data and refined based on feedbacks of the investigators. We finalized the customized software with analysis of various disease-specific parameters and indices. Compared to the data process with device specific programs and other commercial software, the customized software is more flexible, user-friendly and extendable. As conclusion, customized software simplif ies the evaluation process distinctly and help s physicians to focus on study design and result interpretation.