INNOVATIONS IN COMBINING PATIENT REPORTED OUTCOMES WITH COGNITIVE TESTING DATA TO STREAMLINE AND LEVERAGE REAL-TIME DATA COLLECTION
Author(s)
Curry CPHT Corporation, Boston, MA, USA
Presentation Documents
OBJECTIVES: Understand features of an electronic device that allow a marked improvement in the quality of collected data; the importance of improved data quality leading to enhanced patient safety and drug labeling; populations best suited for paired PRO and cognitive measurement technologies; important practical considerations for implementation in clinical trials including training and compliance; the potential for using real-time parallel data for adverse event safety monitoring. METHODS: This session discusses using ePRO and biometric technology for parallel data capture emphasizing advantages, disadvantages, execution, and ways to leverage these data. The session will review PRO and cognitive testing technologies, including comparisons of devices that combine physiological measures with a patient interface with systems that use separate PRO input and biometric devices. RESULTS: Assessing a treatment’s ability to enhance or prohibit reduction of cognitive processing efficiency is an emerging study in the pharmaceutical industry. Case studies examine how the use of cognitive function tests in combination with ePRO can enhance the data collection so drug effects otherwise unidentified can be determined. The speaker will discuss the future of ePRO combined with biometric measurements as a standard of clinical research. CONCLUSIONS: Clinical trial endpoints can involve collection of physiologic and patient-reported outcome data; a combination of subjective and objective data. Electronic forms of information capture assure trial efficiencies including edit checks and shorter time to database lock. ePRO provides time-stamped, legible and complete data from subjects. Biometric devices capture the physiological measurements. Typically, cognition data have been collected from patients separately from PRO data during clinical trials, increasing respondent burden and risk of error such as transposing manually entering data. The use of ePRO and biometric devices, evolution of data transmission technology, and greater technologic sophistication of consumers, provide an opportunity for parallel electronic data capture, simultaneously capturing and transmitting physiologic and PRO parameters in clinical studies.
Conference/Value in Health Info
2010-11, ISPOR Europe 2010, Prague, Czech Republic
Value in Health, Vol. 13, No. 7 (November 2010)
Code
PMH56
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Mental Health