Clinical data acquisition utilising mobile technology

Abstract

The pharmaceutical industry is spending more and more on Research and Development (R&D) every year. In addition, these R&D costs are increasing at a faster rate than sales. In order to resolve this dilemma a significant increase in R&D productivity is required. One of the main contributions to these R&D costs is the acquisition of data during clinical trials. The most important objective of a clinical trial is the collection of high quality data. No matter how well a clinical trial is conducted, if the data quality is poor, a meaningful analysis is not possible. The data acquisition method therefore plays a significant role in the overall outcome of a clinical trial. In this study a Mobile Clinical Data Acquisition System (MCDAS) was developed for the electronic collection of high-quality Patient-Reported Outcome (PRO) data. The system consisted of a cellular phone based electronic Diary (eDiary) for capturing data, and a website for administering the collected data. The system was designed so that it could be implemented on any clinical trials, no matter what data was collected. The MCDAS was successfully implemented on two clinical trials. The study shows that electronically capturing clinical data improves the quality of data obtained, thereby reducing the time and costs associated with clinical trials.