PRM194 - Why Aren’t All Pro/Coa Clinical Trials Using Electronic Data Collection To Optimize Data Integrity And Patient Experience?

Abstract

In this conceptual paper, we will explore reasons for continued use of paper data collection for Patient Reported Outcomes (PRO) and Clinical Outcome Assessments (COA). Reasons include instruments designed specifically for paper, the inability to determine true risks of paper-use, unknown true costs of electronic vs. paper administration, instrument author barriers (only allowing paper administration, costly requirements for migration), unclear translation expectations, and a general fear of the unknown. As electronic PRO/COA (ePRO/eCOA) offers several benefits over paper, including enhanced patient experience, improved compliance, and higher data quality, we will compare the advantages of electronically captured PRO/COA data to that captured via paper in order to show that ePRO/eCOA benefits far outweigh those of paper. The support and advocacy of ePRO/eCOA in clinical trials by regulatory authorities will be reviewed, along with describing current trends of the general population shifting towards the use of electronic devices in their daily routines. In focusing on patient centered clinical trials, ePRO/eCOA makes a significant contribution in reducing patient burden and optimizing their overall experience with making their required assessment entries. Additionally, this conceptual paper will focus on how PROs can be integrated into the eClinical solution to reduce the burden to patients, sites, and clinical teams and discuss this in relation to each phase of a clinical trial including set-up, management (also referred to as maintenance), and close-out. The risks and mitigation strategies in transitioning to ePRO/eCOA collection modes will be evaluated to provide guidance for the successful transition from paper to an integrated electronic PRO/COA solution. In this age of technological advancements, including an integration plan in clinical trials, can help to alleviate many of the obstacles in transitioning from paper to electronic PRO/COA while also mitigating potential risks and minimizing the burden to patients and clinical trial personnel.