![]() Real-time data are not available to support timely enrollment decisions, to manage compliance, to detect emerging problems in the trial, or to support adaptive trial designs.If the data are intended to support an endpoint with the diabetes trial or study collecting data for submission or post-marketing verification, the following issues with paper become too expensive in terms of risk and resources: When the trials or studies are not collecting endpoint data, the disadvantages of paper methods may be manageable. Requirements for treatment and management of emergent events anticipated with these patients.įor many sponsors and clinical research organizations the decision to collect patient data on paper diaries or electronic ones is an economic issue.Complex randomization schemes and various defined treatment regimens.Study designs with inclusion and exclusion criteria that involve daily measures during screening.Patient data collection at various locations-the site, at home, at work, at school, etc.This article highlights the conversion from paper to ePRO for a PRO instrument designed to assess the impact of diabetes on the quality of life of patients with diabetes.ĭiabetes programs are similar to other therapeutic areas, but often require these additional components: The likelihood of comparability or measurement equivalence of the ePRO version to the paper one depends on the degree to which there is modification of the content, format, and usability of the PRO items and scales. The primary goal when transitioning from the use of paper questionnaires to versions administered electronically is to preserve psychometric validation by minimizing the degree of change between the paper version and the electronic one. Transitioning a diary or questionnaire from paper to electronic formats requires physically modifying the appearance of the diary or questionnaire to fit on the screen of a device. This simplifies and streamlines the entire data collection and management process. Many sponsors leverage technologies by collecting symptom, event, and quality of life (QOL) data on the same electronic platform. The use of electronic patient reported outcome (ePRO) data in clinical research is increasing as regulatory authorities acknowledge the credibility of such data, particularly in comparison to paper and pencil self-reports completed in unsupervised settings. Data are collected directly from patients on diaries and/or questionnaires, which are either printed on paper or available on electronic devices. ![]() ![]() As such, biopharmaceutical companies and researchers around the world are working to identify new, effective and safe treatments to help this growing patient population.ĭiabetes clinical research often includes patient reported outcomes (PROs) to measure symptoms and safety over the course of the trial, quality of life, and the economic burden of the disease.
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