LAUSR

ACKNOWLEDGMENTS Complete and accurate data is the cornerstone of any clinical trial – without it, it is impossible to make sound inferences about the safety and effectiveness of an experimental treatment. Data on the patient’s experience of a disease/condition and its treatment in clinical trials has grown in importance over the years, with an industry focus on the development of high quality clinical outcome assessment (COA) tools and, in particular, patient-reported outcome (PRO) measures. The traditional technology for capturing PRO data has been paper. However, with the recognition of the limitations of paper-based data collection and the increased availability of reliable and relatively inexpensive hardware, the electronic collection of these data (i.e., ePRO) is rapidly becoming the mainstream method of data capture in clinical trials.